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1)https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8526756/ (cost of the CRISPER transference process (dCas9/CRISPR is a viable method of epigenetic editing, using the DNMT3A catalytic domain)?)
2) can the work described in the paper(https://link.springer.com/article/10.1007/s11060-023-04531-z) be found at https://clinicaltrials.gov/ ?
3) was this proof of concept carried out in live human beings?
"Great news for $NWBO & #DCVax. It appears that Dr. Linda Liau and her team at UCLA have successfully used CRISPR technology to change unmethylated cancer patients into methylated patients. This will help enable more solid tumor cancer patients to be cured: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173680608"
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173681773
Great news for $NWBO & #DCVax. It appears that Dr. Linda Liau and her team at UCLA have successfully used CRISPR technology to change unmethylated cancer patients into methylated patients. This will help enable more solid tumor cancer patients to be cured: https://t.co/zxPNSRjmVC…
— ATLnsider (@ATLnsider) January 23, 2024
Dr. Al Musella is also excited about the prospects of this CRISPR technology helping more GBM patients. IMO this technology will also help $NWBO #DCVax effectively treat more GBM patients & other solid tumor cancer patients. Patients with methylated gene type are also more… pic.twitter.com/Jd2JZhAkkF
— ATLnsider (@ATLnsider) January 23, 2024
Danielle's NHS oncologist has referred her to Professor Ashkan in The London Neurosurgery Partnership for a dendritic cell vaccine which could be life-saving. DCVax-L is a personalised vaccine made from each patient's own dendritic cells a type of cell that helps the immune system recognise and attack cancer cells. But the treatment isn't available on the NHS and can only be funded privately, which costs £250,000.
https://www.mirror.co.uk/news/uk-news/mum-given-just-14-months-31926610
https://www.nbcnews.com/health/cancer/fda-says-cancer-treatment-car-t-therapy-may-increase-risk-cancer-rcna135262?utm_source=flipboard&utm_content=topic%2Fnews
CANCER
FDA says cancer treatment CAR-T therapy may increase risk of cancer
The agency is requiring drugmakers to add a warning label to its CAR-T therapy products, but it noted that the benefits of the treatment still outweigh the potential risks.
Non-Hodgkin’s Lymphomas under microscopy
Non-Hodgkin lymphoma, seen under a microscope, can be treated with CAR-T therapy. Getty Images
Jan. 23, 2024, 7:09 PM EST
By Berkeley Lovelace Jr.
The Food and Drug Administration this week told several drugmakers to add a boxed warning — the agency’s strongest safety label — to the prescribing information for a type of cancer treatment called CAR-T therapy, saying the treatment itself may increase a person’s risk of cancer.
Carly Kempler, a spokesperson for the FDA, said that, despite the warning, "the overall benefits of these products continue to outweigh their potential risks."
The agency’s decision to update the labels was based on reports of rare blood cancers in patients who had previously gotten CAR-T therapy, Kempler said. As of Monday, the agency had received 25 reports of the blood cancers in CAR-T patients, she said.
Bruce Levine, a professor in cancer gene therapy at the University of Pennsylvania, said that in addition to the reports submitted to the FDA, two abstracts published late last year in the journal Blood also cited a potential cancer risk associated with CAR-T therapy, which likely “forced the FDA’s hand.”
CAR-T — or chimeric antigen receptor T cell — therapy uses a patient’s own immune cells to treat certain blood cancers, such as leukemia, multiple myeloma and lymphoma. It involves harvesting the immune cells — in this case, T cells — then genetically altering them in a lab to make them target cancer cells, and finally reinfusing them back into the patient.
It’s proven to be highly effective in hard-to-treat cases, experts said. In 2022, doctors who had treated two leukemia patients with CAR-T a decade ago said it was fair to say the therapy had cured the patients of the disease.
“This has been a game changer when we think about treating lymphoma and other diseases,” said Dr. Matthew Frigault, the clinical director of the Massachusetts General Hospital Cellular Immunotherapy Program in Boston.
The first CAR-T therapy, Novartis’ drug Kymriah, received FDA approval in 2017. Since then, another five have been approved.
The makers of five of the drugs — Bristol Myers Squibb, for Abecma and Breyanzi; Gilead Sciences' Kite Pharma, for Yescarta; Johnson & Johnson's Carvykti; and Novartis, for Kymriah — received letters from the FDA, stating that they must submit proposed label changes in the next 30 days to note that, in rare cases, CAR-T therapy can increase the risk of rare blood cancers. (Kite Pharma did not receive a letter about the sixth CAR-T drug, Tecartus.)
If the drugmakers disagree, they can instead submit a rebuttal explaining why a change isn’t needed.
In a statement to NBC News, a spokesperson for Novartis said the company has not found “sufficient evidence” to support a link between cancer and its treatment, which has been used in more than 10,000 patients. However, the spokesperson said, the company will work with the FDA to update its label “appropriately.”
Spokespersons for Johnson & Johnson and Gilead Sciences also said the drugmakers would work with the agency to update their labels.
A spokesperson for Bristol Myers Squibb said the company is evaluating “next steps” following the FDA’s notice, although it has not seen any cancer cases associated with its treatment.
“Patient safety is our top priority,” the spokesperson said.
How might CAR-T therapy cause cancer?
Still, there’s the question of how CAR-T could cause cancer — if it does at all.
CAR-T treatments are still relatively new: Frigault noted that the FDA has required that the makers of the products conduct 15-year follow-up studies to assess the potential risk of secondary cancers following treatment. (Secondary cancers are cancers that can arise from treatment.)
The FDA “is not saying that every single one of the cases they’ve reported has clearly shown CAR-T has led to this,” he said, “but more that there may be an association.”
“This is what the FDA does. They look for a signal,” he added.
If CAR-T does cause cancer, the risk is likely very small, said Dr. Hemant Murthy, a hematology-oncology physician at the Mayo Clinic in Jacksonville, Florida.
More than 27,000 doses of CAR-T therapy have been administered in the U.S., according to the FDA.
“I don’t really see this affecting too much of practice,” Murthy said.
Dr. Saad Usmani, a myeloma physician and cell therapist at Memorial Sloan Kettering, said the label change should support physicians’ current practice of discussing with patients the risk of developing secondary cancers following cancer treatment.
Usmani noted that other cancer treatments, such as radiation and chemotherapy, also carry a risk of secondary cancers.
“The change is expected given the recent reports, albeit very low incidence in such cases,” he said.
Dr. Marcela Maus, an associate professor of medicine at Harvard Medical School and director of the Cellular Immunotherapy Program at Massachusetts General Hospital, said physicians might be more cautious, but it most likely won’t change much in their practice.
“We need to manage the cancer that they have now, so I don’t imagine it being massively different,” she said.
Berkeley Lovelace Jr.
Berkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.
CHAIKIN ANALYTICS
/
When is the Nature Pre Print due for publication ? https://t.co/AqCgR5j5dY…TRIAL REGISTRATION: https://t.co/nUBxJHCqQp Identifier: NCT01204684 $nwbo @alphavestcap https://t.co/aXFjLWNT46
— alphavestcapital.com (@alphavestcap) January 23, 2024
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173678618
ATLnsider
Re: abc1212 post# 666327
Tuesday, January 23, 2024 9:15:07 AM
Post#
666339
of 666402
I agree abc1212, Dr. Liau and her team at UCLA are quietly and deliberately finding a cure for 100% of GBM patients.
Using DCVax has moved the cure rate from around 5% to around 13%. Using DCVax along with poly-ICLC has moved the cure rate to about 50%.
Adding combination treatments, like PD-1 inhibitors, PDL-1 inhibitors, and CSF-1R inhibitors may move the cure rate to 65%+.
Now, using DCVax along with poly-ICLC, along with other combination treatments like PD-1 inhibitors, PDL-1 inhibitors, CSF-1R inhibitors, and CRISPR technology to convert unmethylated patients into methylated patients, will get Dr. Liau closer to her goal of helping 100% of cancer patients.
ATLnsider
Re: None
Tuesday, January 23, 2024 1:59:32 AM
Post#
666251
of 666403
Apparently, according to this article that was published last week on 1/15/2024, researchers at UCLA, including Dr. Linda Liau, Dr. Timothy Cloughesy and Dr. Phionah NghiemPhu, have been able to use CRISPR gene editing technology to change unmethylated GBM patients into methylated GBM patients.
https://link.springer.com/article/10.1007/s11060-023-04531-z
The CRISPR technology is a method of epigenetic editing, and these researchers were able to convert unmethylated patients into patients with MGMT methylation.
The primary stated purpose of this study was to make the unmethylated patients more sensitive to chemotherapy, and increase PFS and OS for unmethylated patients.
However, we also know that unmethylated patients are also less sensitive to immunotherapy treatments, and the average PFS and OS for unmethylated patients, treated with immunotherapies, is less than what it is for methylated patients.
This CRISPR technology that will convert unmethylated patients into methylated patients, bodes well for DCVax along with poly-ICLC as a monotherapy, and DCVax along with poly-ICLC in combination with other treatments, like PD-1 inhibitors, PDL-1 inhibitors, and CSF-1R inhibitors.
In fact, I believe chemotherapy treatments will not be needed at all. Only DCVax-L along with poly-ICLC, and the other combination treatments will be used to treat patients in the future.
https://www.researchsquare.com/article/rs-3287211/v1
Autologous tumor lysate-pulsed dendritic cell (ATL-DC) vaccination is a promising immunotherapy for patients with high grade gliomas, but responses have not been demonstrated in all patients. To determine the most effective combination of autologous tumor lysate-pulsed DC vaccination, with or without the adjuvant toll-like receptor (TLR) agonists poly-ICLC or resiquimod, we conducted a Phase 2 clinical trial in 23 patients with newly diagnosed or recurrent WHO Grade III-IV malignant gliomas. We then performed deep, high-dimensional immune profiling of these patients to better understand how TLR agonists may influence the systemic immune responses induced by ATL-DC vaccination. Bulk RNAseq data demonstrated highly significant upregulation of type 1 and type 2 interferon gene expression selectively in patients who received adjuvant a TLR agonist together with ATL-DC. CyTOF analysis of patient peripheral blood mononuclear cells (PBMCs) showed increased expression of PD-1 on CD4+ T-cells, decreases in CD38 and CD39 on CD8+ T cells and elevated proportion of monocytes after ATL-DC + TLR agonist administration. In addition, scRNA-seq demonstrated a higher expression fold change of IFN-induced genes with poly-ICLC treatment in both peripheral blood monocytes and T lymphocytes. Patients who had higher expression of interferon response genes lived significantly longer and had longer time to progression compared to those with lower expression. The results suggest that ATL-DC in conjunction with adjuvant poly-ICLC induces a polarized interferon response in circulating monocytes and specific activation of a CD8+ T cell population, which may represent an important blood biomarker for immunotherapy in this patient population.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01204684
Biological sciences/Cancer/CNS cancer
https://www.reddit.com/r/NWBO/comments/198skz4/nwbo_the_work_of_robert_prins_and_his_team/
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173627729
https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/
https://nwbio.com/video-dr-marnix-bosch-speaks-at-asco-2023/
https://nwbio.com/wp-content/uploads/NWBT_ASCO_slides_06032023_FINAL.pdf
https://smithonstocks.com/highly-probable-uk-approval-of-dcvax-l-in-1h-2024-would-be-a-crowning-achievement-for-northwest-biotherapeutics/
Why Dendritic Cell Vaccines Like DCVax-L Promise to be A Major Advance in Solid Cancer Therapy
The company’s press release of December 21, 2023 eloquently explains the reasoning that leads me to conclude that dendritic cell vaccines represent a novel, paradigm shifting approach to treating in not just GBM but all resectable solid tumors. I quote from the press release:
“One of the key factors making GBM so difficult to treat is that it is an extremely heterogeneous tumor. Accumulating evidence suggests that intratumor heterogeneity likely is the key to understanding treatment failure in GBM (Sottoriva, PNAS, 2013). Another key challenge is that as GBM develops, it induces an immunosuppressive microenvironment which compounds the difficulty of mounting an effective immune response against the tumor - especially within the central nervous system, which is an immune privileged space behind the blood brain barrier.
DCVax-L is designed to address both of these key challenges. As the Company previously reported, proteomic studies have demonstrated that a single tumor lysate sample contained tens of thousands of different peptides and, out of this pool, the dendritic cells selected, processed and presented over 600 different peptides (tumor targets) to T cells. T cell studies (TCR sequencing and T cell clonal expansion assays) analyzing the breadth and strength of T cell response following DCVax-L treatment have found extensive responses, including clonal expansion of up to 800 T cell clones at month 4 and up to 1200 T cell clones at month 8 in the samples studied. Each T cell clone focuses on a particular and distinct target. In individuals not being treated with the vaccine, only 2 – 20 new T cells clones are seen between month 4 and month 8.
The results of these proteomic, T cell and other studies provide support for what the Company believes to be the mechanism of action of DCVax-L: i.e., mobilizing a broad spectrum and strong de novo T cell response that addresses the extensive heterogeneity of GBM and overcomes the immunosuppressive microenvironment around the tumor.
The Company believes that this mechanism of action will be applicable for most types of solid tumors. Solid tumors comprise approximately 90% of all cancers, and a key difficulty that other treatment approaches have encountered with solid tumors is their heterogeneity.
The Company has already had positive results with DCVax-L in some compassionate use cases with other diverse solid tumors. The Company looks forward to building on its experience with DCVax-L in GBM and the compassionate use cases to address a wide range of other operable solid tumors.
The Company also had positive results in its Phase 1 trial of DCVax-Direct, in which more than a dozen diverse types of inoperable solid tumors were treated. DCVax-Direct involves essentially the same mechanism of action as DCVax-L, except that the tumor target proteins are taken up by the dendritic cells in situ in the tumor following intra-tumoral injection, rather than from tumor lysate from a surgically resected tumor tissue sample. The Company looks forward to resuming its clinical development of DCVax-Direct for a wide range of inoperable solid tumors.” (Note that the underlining for emphasis is mine.)
https://twitter.com/AllenTurner206?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1625866069780070401%7Ctwgr%5Ef63c5686b065b5071c66f18f79c23977002be4ca%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Finvestorshub.advfn.com%2Fboards%2Fread_msg.aspx%3Fmessage_id%3D173678492
https://www.reddit.com/r/wallstreetbets/comments/1995j9e/the_american_system_profits_over_life_a_tiny/?sort=new
https://classic.clinicaltrials.gov/ct2/show/NCT01204684
Re: The Danish Dude post# 666269
666374
The Danish Dude:Does the LL- UCLA -Spore clinic have a third registrational trial wth dc vax l ? A.E.K.
Re: Guzzi62 post# 666267
Tuesday, January 23, 2024 5:00:57 AM
Post#
666269
of 666373
That is the DCVax-L + poly-iclc + Keytruda trial
https://classic.clinicaltrials.gov/ct2/show/NCT04201873
This is the correct DCVax-L + poly-iclc trial
https://clinicaltrials.gov/study/NCT01204684
marzan
Re: Guzzi62 post# 666267
Tuesday, January 23, 2024 5:44:08 AM
Post#
666274
of 666374
TDD is correct that he is mentioning the Jan 31st 2024 the Expected Primary Completion date for the PCLYC combo trial that is about14 yrs old since the trial start date. The failure of the Keytruda + PLX 3697 combo trial to treat the easy to treat melanoma cancer is testimony that DcVaxL is indispensable in any Keytruda combo. Expected primary completion for this combo: DCVaxL + PCLYC + Keytruda+PLX 3697 is Aug 2024 after about 4 yrs of the trial start date. No wonder Merck is expanding its PA plant like crazy as it is eyeing for the Tumor Agnostic approval in the near future. Recall Merck tried combo trials with so many other cancer companies including Daisy Senkaye PLX 3697, but none of those have been this effective and fruitful as in the case of our hard to treat rGBM combo trial. Watch the Cementing combo phase 3 trial iPR is announced soon expanding the 40 patients phase 2 to 100 patients phase 3 and the big times for NWBO longs begin any day, imo.
ATLnsider
Re: newman2021 post# 666336
Tuesday, January 23, 2024 9:28:44 AM
Post#
666344
of 666377
Thanks newman2021, unfortunately I don’t know when the nature article will come out.
But, in addition to the nature article, I am more looking forward to NWBio being the Sponsor or a major collaborator, on multiple registrational Phase II/III clinical basket trials, that will test the safety and efficacy of both DCVax-L and DCVax Direct, in treating all or most solid tumor cancer, both operable and inoperable, using RWE and/or RWD.
I hope these basket trials will look at DCVax-L or DCVax Direct (depending if the tumors are operable or inoperable), along with poly-ICLC, as the control group, and DCVax along with poly-ICLC, in combination with other treatments like PD-1 inhibitors, PDL-1 inhibitors, and CSF-1R inhibitors, as the treatment group.
ATLnsider
Re: abc1212 post# 666327
Tuesday, January 23, 2024 9:15:07 AM
Post#
666339
of 666382
I agree abc1212, Dr. Liau and her team at UCLA are quietly and deliberately finding a cure for 100% of GBM patients.
Using DCVax has moved the cure rate from around 5% to around 13%. Using DCVax along with poly-ICLC has moved the cure rate to about 50%.
Adding combination treatments, like PD-1 inhibitors, PDL-1 inhibitors, and CSF-1R inhibitors may move the cure rate to 65%+.
Now, using DCVax along with poly-ICLC, along with other combination treatments like PD-1 inhibitors, PDL-1 inhibitors, CSF-1R inhibitors, and CRISPR technology to convert unmethylated patients into methylated patients, will get Dr. Liau closer to her goal of helping 100% of cancer patients.
Bullish
BULLISH
This is a PSA to all manipulative and collusive Market Makers, Hedge Funds and Short Sellers:
ae kusterer
Re: None
Tuesday, January 23, 2024 10:10:30 AM
Post#
666367
of 666384
ATLnsider
Re: None
Tuesday, January 23, 2024 1:59:32 AM
Post#
666251
of 666366
Apparently, according to this article that was published last week on 1/15/2024, researchers at UCLA, including Dr. Linda Liau, Dr. Timothy Cloughesy and Dr. Phionah NghiemPhu, have been able to use CRISPR gene editing technology to change unmethylated GBM patients into methylated GBM patients.
https://link.springer.com/article/10.1007/s11060-023-04531-z
The CRISPR technology is a method of epigenetic editing, and these researchers were able to convert unmethylated patients into patients with MGMT methylation.
The primary stated purpose of this study was to make the unmethylated patients more sensitive to chemotherapy, and increase PFS and OS for unmethylated patients.
However, we also know that unmethylated patients are also less sensitive to immunotherapy treatments, and the average PFS and OS for unmethylated patients, treated with immunotherapies, is less than what it is for methylated patients.
This CRISPR technology that will convert unmethylated patients into methylated patients, bodes well for DCVax along with poly-ICLC as a monotherapy, and DCVax along with poly-ICLC in combination with other treatments, like PD-1 inhibitors, PDL-1 inhibitors, and CSF-1R inhibitors.
In fact, I believe chemotherapy treatments will not be needed at all. Only DCVax-L along with poly-ICLC, and the other combination treatments will be used to treat patients in the future.
Bullish
BULLISH
This is a PSA to all manipulative and collusive Market Makers, Hedge Funds and Short Sellers:
TIME IS RUNNING OUT. THE CLOCK IS TICKING!!!
hyperopia
Re: None
Tuesday, January 23, 2024 8:31:40 AM
Post#
666310
of 666369
Nature article about recent cell therapy deals
some highlights:
Pharma spends big to access key cell and gene therapy assets
High-value cell therapy deals are driving investment in the cell and gene therapy field, but new approaches such as gene editing are also beginning to contribute.
By Mike Ward 16 November 2023
In the ever-evolving landscape of biotechnology and pharmaceuticals, one sector has emerged as particularly promising in the quest to combat previously untreatable diseases: cell and gene therapy. Half a century after scientists proposed the idea of modifying defective genes to treat diseases with a genetic root, the approach is beginning to bear fruit.
To date, the United States Food and Drug Administration (FDA) has approved 31 cell and gene therapies, ten of which are targeting oncology indications. It has also approved multiple oligonucleotide-based drugs, while all eyes are currently on whether the agency will approve the first therapy developed using a gene-editing technology for sickle cell disease and beta thalassemia in December 2023.
Groundbreaking cell and gene therapy technologies have the potential to revolutionize medicine, offering new hope to patients facing previously insurmountable challenges and so have emerged as an attractive target for pharmaceutical companies. However, the journey from discovery to market is fraught with complexity, and therefore dealmaking could play a pivotal role in shaping the future of the field.
In the 12 months to the end of September 2023, according to BioWorld, 246 partnership deals focusing on cell and gene therapy programs and platforms were signed, of which 43 also disclosed financial details. During this 12-month period, the three highest valued deals were signed in 2022. In 2023, the leading ten transactions have a potential value of $16.8 billion.
Cell therapy-focused deals
Many of the deals signed in the cell and gene therapy space involve cell therapies for cancer, and several deals in recent years have been penned for pharma companies to access next-generation cell therapy opportunities. For example, in August 2022, Roche signed a deal with Poseida Therapeutics to develop allogeneic CAR-T cell therapies for blood cancers including multiple myeloma, B cell lymphomas and other indications. Poseida will receive an upfront payment of $110 million, and if milestones are met Poseida could receive up to $6 billion, which makes this deal one of the most potentially valuable in the field in recent years. Also targeting multiple myeloma through a high-value deal, Arcellx and Kite Pharma joined forces in December 2022 to co-develop and co-commercialize Arcellx’s phase 2 cell therapy CART-ddBCMA (Table 1).
Big pharma Bristol Myers Squibb (BMS) also signed a couple of high-value oncology-focused deals earlier in 2022. In January 2022, BMS partnered with Century Therapeutics to use their induced pluripotent stem cell (iPSC)-based allogeneic cell therapy platforms to develop up to four iPSC-derived, natural killer cell and/or T cell programs to treat hematologic malignancies and solid tumors. BMS then expanded its relationship with Immatics to develop allogeneic TCR-T/CAR-T programs using Immatics’ gamma delta T cell-derived, adoptive cell therapy (ACT) platform, ACTallo . . . .
Freedom to operate
One of the challenges for companies attempting to establish cell and gene therapy partnerships is to ensure that they have all the elements in place to have freedom to operate. In addition to the scientific challenges, issues around manufacturing and scale-up need to be addressed, often requiring access to the intellectual property estates of other organizations. Indeed, with CRISPR-Cas9 platforms, the challenge potential partners face is the fact that the United States and European Union have given primacy to different patent estates.
While the biggest headline-grabbing transactions have involved pharmaceutical companies getting access to promising therapeutic candidates, most of the deals are focused on tapping into the technologies that are essential to developing and manufacturing these new generations of therapies. Indeed, some of the transactions associated with manufacturing technologies can be very complex as pharma stack up the patents needed to have freedom to operate.
Clearly, the promise of cell and gene therapy is immense, with the potential to revolutionize the treatment of numerous diseases. So, as the industry evolves and technologies advance, the art of dealmaking will remain at the forefront of bringing these life-changing therapies from the laboratory to the clinic, offering hope to patients who have long awaited a cure.
https://www.nature.com/articles/d43747-023-00093-1
One of my takeaways is that the the tide is turning, and Big Pharma’s former reluctance to consider a different operating model is changing. These companies are definitely aware of, and eager to partner with seemingly obscure gene and cell therapy companies, as noted by the sheer number of deals that were made last year, (~250) and that in the vast majority, (over 200) the financial details are actually unknown. So if anyone thinks that just because a deal hasn’t been struck with Northwest Bio yet, that Big Pharma companies aren’t interested, well nothing could be further from the truth.
Another, is that most of them are pre-clinical or early-phase developmental deals, to treat rare diseases with very small patient populations, while Northwest Bio is very late-stage, and targeting solid-tumor cancers, which is a massive potential patient population.
Additionally, many of the deals are focused on manufacturing technologies, which are complex and difficult to develop, and great importance is placed on having the patent protections to operate freely, and maintain superiority (and high pricing).
So, to sum it up:
In comparison to virtually ALL of those companies, Northwest Bio is sitting in a very enviable partnership/buyout position; late-stage in their development, with marketing approval and automated manufacturing capability in hand, (or nearly, depending on timing) as well as a multi-patented manufacturing process, while addressing a massive, highly-desired market.
I’ve said this before, but I think it deserves repeating: Underestimate Linda Powers at your own peril. One of the many things she does clearly understand, is negotiating leverage.
Tuesday, January 23, 2024 10:44:18 AM
Post#
666383
of 666386
https://www.fiercebiotech.com/biotech/merck-co-signs-220m-macrocyclic-peptide-deal-after-hailing-next-wave-drug-discovery
The Danish Dude:Does the LL- UCLA -Spore clinic have a third registrational trial wth dc vax l ? A.E.K.
Re: Guzzi62 post# 666267
Tuesday, January 23, 2024 5:00:57 AM
Post#
666269
of 666373
That is the DCVax-L + poly-iclc + Keytruda trial
https://classic.clinicaltrials.gov/ct2/show/NCT04201873
This is the correct DCVax-L + poly-iclc trial
https://clinicaltrials.gov/study/NCT01204684
marzan
Re: Guzzi62 post# 666267
Tuesday, January 23, 2024 5:44:08 AM
Post#
666274
of 666374
TDD is correct that he is mentioning the Jan 31st 2024 the Expected Primary Completion date for the PCLYC combo trial that is about14 yrs old since the trial start date. The failure of the Keytruda + PLX 3697 combo trial to treat the easy to treat melanoma cancer is testimony that DcVaxL is indispensable in any Keytruda combo. Expected primary completion for this combo: DCVaxL + PCLYC + Keytruda+PLX 3697 is Aug 2024 after about 4 yrs of the trial start date. No wonder Merck is expanding its PA plant like crazy as it is eyeing for the Tumor Agnostic approval in the near future. Recall Merck tried combo trials with so many other cancer companies including Daisy Senkaye PLX 3697, but none of those have been this effective and fruitful as in the case of our hard to treat rGBM combo trial. Watch the Cementing combo phase 3 trial iPR is announced soon expanding the 40 patients phase 2 to 100 patients phase 3 and the big times for NWBO longs begin any day, imo.
ATLnsider
Re: newman2021 post# 666336
Tuesday, January 23, 2024 9:28:44 AM
Post#
666344
of 666377
Thanks newman2021, unfortunately I don’t know when the nature article will come out.
But, in addition to the nature article, I am more looking forward to NWBio being the Sponsor or a major collaborator, on multiple registrational Phase II/III clinical basket trials, that will test the safety and efficacy of both DCVax-L and DCVax Direct, in treating all or most solid tumor cancer, both operable and inoperable, using RWE and/or RWD.
I hope these basket trials will look at DCVax-L or DCVax Direct (depending if the tumors are operable or inoperable), along with poly-ICLC, as the control group, and DCVax along with poly-ICLC, in combination with other treatments like PD-1 inhibitors, PDL-1 inhibitors, and CSF-1R inhibitors, as the treatment group.
Bullish
ATLnsider
Re: None
Tuesday, January 23, 2024 1:59:32 AM
Post#
666251
of 666366
Apparently, according to this article that was published last week on 1/15/2024, researchers at UCLA, including Dr. Linda Liau, Dr. Timothy Cloughesy and Dr. Phionah NghiemPhu, have been able to use CRISPR gene editing technology to change unmethylated GBM patients into methylated GBM patients.
https://link.springer.com/article/10.1007/s11060-023-04531-z
The CRISPR technology is a method of epigenetic editing, and these researchers were able to convert unmethylated patients into patients with MGMT methylation.
The primary stated purpose of this study was to make the unmethylated patients more sensitive to chemotherapy, and increase PFS and OS for unmethylated patients.
However, we also know that unmethylated patients are also less sensitive to immunotherapy treatments, and the average PFS and OS for unmethylated patients, treated with immunotherapies, is less than what it is for methylated patients.
This CRISPR technology that will convert unmethylated patients into methylated patients, bodes well for DCVax along with poly-ICLC as a monotherapy, and DCVax along with poly-ICLC in combination with other treatments, like PD-1 inhibitors, PDL-1 inhibitors, and CSF-1R inhibitors.
In fact, I believe chemotherapy treatments will not be needed at all. Only DCVax-L along with poly-ICLC, and the other combination treatments will be used to treat patients in the future.
Bullish
BULLISH
This is a PSA to all manipulative and collusive Market Makers, Hedge Funds and Short Sellers:
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Nature article about recent cell therapy deals
some highlights:
Pharma spends big to access key cell and gene therapy assets
High-value cell therapy deals are driving investment in the cell and gene therapy field, but new approaches such as gene editing are also beginning to contribute.
By Mike Ward 16 November 2023
In the ever-evolving landscape of biotechnology and pharmaceuticals, one sector has emerged as particularly promising in the quest to combat previously untreatable diseases: cell and gene therapy. Half a century after scientists proposed the idea of modifying defective genes to treat diseases with a genetic root, the approach is beginning to bear fruit.
To date, the United States Food and Drug Administration (FDA) has approved 31 cell and gene therapies, ten of which are targeting oncology indications. It has also approved multiple oligonucleotide-based drugs, while all eyes are currently on whether the agency will approve the first therapy developed using a gene-editing technology for sickle cell disease and beta thalassemia in December 2023.
Groundbreaking cell and gene therapy technologies have the potential to revolutionize medicine, offering new hope to patients facing previously insurmountable challenges and so have emerged as an attractive target for pharmaceutical companies. However, the journey from discovery to market is fraught with complexity, and therefore dealmaking could play a pivotal role in shaping the future of the field.
In the 12 months to the end of September 2023, according to BioWorld, 246 partnership deals focusing on cell and gene therapy programs and platforms were signed, of which 43 also disclosed financial details. During this 12-month period, the three highest valued deals were signed in 2022. In 2023, the leading ten transactions have a potential value of $16.8 billion.
Cell therapy-focused deals
Many of the deals signed in the cell and gene therapy space involve cell therapies for cancer, and several deals in recent years have been penned for pharma companies to access next-generation cell therapy opportunities. For example, in August 2022, Roche signed a deal with Poseida Therapeutics to develop allogeneic CAR-T cell therapies for blood cancers including multiple myeloma, B cell lymphomas and other indications. Poseida will receive an upfront payment of $110 million, and if milestones are met Poseida could receive up to $6 billion, which makes this deal one of the most potentially valuable in the field in recent years. Also targeting multiple myeloma through a high-value deal, Arcellx and Kite Pharma joined forces in December 2022 to co-develop and co-commercialize Arcellx’s phase 2 cell therapy CART-ddBCMA (Table 1).
Big pharma Bristol Myers Squibb (BMS) also signed a couple of high-value oncology-focused deals earlier in 2022. In January 2022, BMS partnered with Century Therapeutics to use their induced pluripotent stem cell (iPSC)-based allogeneic cell therapy platforms to develop up to four iPSC-derived, natural killer cell and/or T cell programs to treat hematologic malignancies and solid tumors. BMS then expanded its relationship with Immatics to develop allogeneic TCR-T/CAR-T programs using Immatics’ gamma delta T cell-derived, adoptive cell therapy (ACT) platform, ACTallo . . . .
Freedom to operate
One of the challenges for companies attempting to establish cell and gene therapy partnerships is to ensure that they have all the elements in place to have freedom to operate. In addition to the scientific challenges, issues around manufacturing and scale-up need to be addressed, often requiring access to the intellectual property estates of other organizations. Indeed, with CRISPR-Cas9 platforms, the challenge potential partners face is the fact that the United States and European Union have given primacy to different patent estates.
While the biggest headline-grabbing transactions have involved pharmaceutical companies getting access to promising therapeutic candidates, most of the deals are focused on tapping into the technologies that are essential to developing and manufacturing these new generations of therapies. Indeed, some of the transactions associated with manufacturing technologies can be very complex as pharma stack up the patents needed to have freedom to operate.
Clearly, the promise of cell and gene therapy is immense, with the potential to revolutionize the treatment of numerous diseases. So, as the industry evolves and technologies advance, the art of dealmaking will remain at the forefront of bringing these life-changing therapies from the laboratory to the clinic, offering hope to patients who have long awaited a cure.
https://www.nature.com/articles/d43747-023-00093-1
One of my takeaways is that the the tide is turning, and Big Pharma’s former reluctance to consider a different operating model is changing. These companies are definitely aware of, and eager to partner with seemingly obscure gene and cell therapy companies, as noted by the sheer number of deals that were made last year, (~250) and that in the vast majority, (over 200) the financial details are actually unknown. So if anyone thinks that just because a deal hasn’t been struck with Northwest Bio yet, that Big Pharma companies aren’t interested, well nothing could be further from the truth.
Another, is that most of them are pre-clinical or early-phase developmental deals, to treat rare diseases with very small patient populations, while Northwest Bio is very late-stage, and targeting solid-tumor cancers, which is a massive potential patient population.
Additionally, many of the deals are focused on manufacturing technologies, which are complex and difficult to develop, and great importance is placed on having the patent protections to operate freely, and maintain superiority (and high pricing).
So, to sum it up:
In comparison to virtually ALL of those companies, Northwest Bio is sitting in a very enviable partnership/buyout position; late-stage in their development, with marketing approval and automated manufacturing capability in hand, (or nearly, depending on timing) as well as a multi-patented manufacturing process, while addressing a massive, highly-desired market.
I’ve said this before, but I think it deserves repeating: Underestimate Linda Powers at your own peril. One of the many things she does clearly understand, is negotiating leverage.
$nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) January 23, 2024
"Since ABECMA (bmy) approved 3/21,now .. aware of the risk of T cell malignancies, with serious outcomes, including hospitalization and death,... with BCMA- and CD19-directed genetically modified autologous T cell immunotherapieshttps://t.co/Pt3ZJtRGlR
https://www.fda.gov/media/175623/download?attachment
Celgene Corporation,
A Bristol-Myers Squibb Company
Attention: Brittany Dustman
3401 Princeton Pike
Lawrenceville, NJ 08648
Dear Ms. Dustman:
Please refer to your Biologics License Application (BLA) submitted under section 351(a)
of the Public Health Service Act for idecabtagene vicleucel.
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA
to require holders of approved drug and licensed biological product applications to make
safety related labeling changes based upon new safety information that becomes
available after approval of the drug or biological product.
Since ABECMA (idecabtagene vicleucel) was approved on March 26, 2021, we have
become aware of the risk of T cell malignancies, with serious outcomes, including
hospitalization and death, following treatment with BCMA- and CD19-directed
genetically modified autologous T cell immunotherapies. FDA identified postmarketing
adverse event and clinical trial reports describing occurrence of mature T cell
malignancies, including CAR-positive tumors, following treatment with BCMA- and
CD19-directed genetically modified autologous T cell immunotherapies. For additional
information please see CBER safety communication titled, “FDA Investigating Serious
Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous
Chimeric Antigen Receptor (CAR) T cell Immunotherapies,” and a posting at July -
September 2023 | Potential Signals of Serious Risks/New Safety Information Identified
by the FDA Adverse Event Reporting System (FAERS) | FDA for BCMA- or CD19-
directed genetically modified autologous T cell immunotherapies. We consider this
information to be “new safety information” as defined in section 505-1(b)(3) of the
FDCA. Furthermore, we consider the serious risk of T cell malignancy to be applicable
to all BCMA- and CD19-directed genetically modified autologous T cell
immunotherapies.
In accordance with section 505(o)(4) of the FDCA, we are notifying you that based
on the new safety information described above and discussed during the January
19, 2024 teleconference, we have determined that the new safety information
Page 2 – STN BL 125736/257 – Brittany Dustman
should be included in the labeling for all BCMA- and CD19-directed genetically
modified autologous T cell immunotherapies. For ABECMA (idecabtagene
vicleucel), we have determined that the new safety information should be included
in the labeling as follows:
1. Boxed Warning, Highlights Section of the Prescribing Information (Pl)
T cell malignancies have occurred following treatment with BCMA- and CD19-
directed genetically modified autologous T cell immunotherapies, including
ABECMA. (5.9)
2. Boxed Warning, Full Prescribing Information
T cell malignancies have occurred following treatment with BCMA- and CD19-
directed genetically modified autologous T cell immunotherapies, including
ABECMA [see WARNINGS AND PRECAUTIONS (5.9)].
3. WARNINGS AND PRECAUTIONS, Secondary Malignancies, Highlights
Section of the PI
Secondary malignancies: T cell malignancies have occurred following treatment
with BCMA- and CD19-directed genetically modified autologous T cell
immunotherapies, including ABECMA. (5.9)
4. WARNINGS AND PRECAUTIONS, 5.9 Secondary Malignancies, Full
Prescribing Information
T cell malignancies have occurred following treatment with BCMA- and CD19-
directed genetically modified autologous T cell immunotherapies, including
ABECMA. Mature T cell malignancies, including CAR-positive tumors, may
present as soon as weeks following infusion, and may include fatal outcomes.
[See BOXED WARNING, ADVERSE REACTIONS (6.3), PATIENT
COUNSELING INFORMATION (17).]
5. ADVERSE REACTIONS, 6.3 Postmarketing Experience
Because adverse events to marketed products are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to product exposure.
The following adverse event has been identified during postmarketing use of
ABECMA.
Neoplasms: T cell malignancies
6. Section 17 PATIENT COUNSELING INFORMATION
Secondary Malignancies
Secondary malignancies, including T cell malignancies, have occurred [see
BOXED WARNING, WARNINGS AND PRECAUTIONS (5.9), ADVERSE
REACTIONS (6.3)].
Page 3 – STN BL 125736/257 – Brittany Dustman
7. MEDICATION GUIDE
ABECMA can increase your risk of getting cancers including certain types of
cancers of the immune system. Your provider should monitor you for this.
In accordance with section 505(o)(4), within 30 calendar days of the date of this letter,
you must submit a supplement proposing changes to the approved labeling in
accordance with the above direction or notify FDA that you do not believe a labeling
change is warranted and submit a rebuttal statement detailing the reasons why such a
change is not warranted. If you submit a supplement that includes only language
identical to that specified above, the supplement may be submitted as a changes being
effected (CBE-0) supplement. If the supplement includes proposed language that
differs from that above, submit a prior approval supplement (PAS).
Under section 505(o)(4), if you fail to submit a response within 30 calendar days, you
would be in violation of the FDCA that may deem your product to be misbranded under
section 502(z) and may subject you to enforcement action, including civil monetary
penalties under section 303(f)(4)(A) and an order to make whatever labeling changes
FDA deems appropriate to address the new safety information.
Please submit your safety labeling submission to STN 125736.
Prominently identify the submission with the following wording in bold capital letters at
the top of the first page of the submission, as appropriate:
SAFETY LABELING CHANGES UNDER 505(o)(4) - PRIOR APPROVAL
SUPPLEMENT
OR
SAFETY LABELING CHANGES UNDER 505(o)(4) – CHANGES BEING EFFECTED
OR
SAFETY LABELING CHANGES UNDER 505(o)(4) – REBUTTAL (CHANGE NOT
WARRANTED).”
Prominently identify subsequent submissions related to the safety labeling changes
supplement with the following wording in bold capital letters at the top of the first page of
the submission:
SAFETY LABELING CHANGES UNDER 505(o)(4) - AMENDMENT
If you have any questions, please contact the Regulatory Project Manager, Nevitt
Morris, at (240) 402-8269 or by email at Nevitt.Morris@fda.hhs.gov.
Page 4 – STN BL 125736/257 – Brittany Dustman
Sincerely,
Nicole Verdun, MD
Director
Office of Therapeutic Products
Center for Biologics Evaluation and Research
T-Cell Malignancies Reported in Patients Who Received BCMA- and CD19-Directed CAR T-Cell Therapy
November 29, 2023
Ashling Wahner
News
Article
The FDA has received reports of T-cell malignancies in patients who have been treated with CD19- or BCMA-directed autologous CAR T-cell immunotherapies.
FDA
FDA
The FDA has received reports of T-cell malignancies in patients who have been treated with CD19- or BCMA-directed autologous CAR T-cell immunotherapies.1 These T-cell malignancies include CAR-positive lymphoma and were reported from postmarketing adverse effect (AE) data sources and clinical trials in patients who received several CAR T-cell products in the class.
The FDA has determined that the risk of T-cell malignancies is apparent in all currently approved CD19- and BCMA-directed genetically modified autologous CAR T-cell immunotherapies, including:
Idecabtagene vicleucel (Abecma), which is indicated for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody2
Lisocabtagene maraleucel (Breyanzi), which is indicated for the treatment of adult patients with large B-cell lymphoma (LBCL) who have disease that is refractory to frontline chemoimmunotherapy or that has relapsed within 12 months of frontline chemoimmunotherapy; disease that is refractory to frontline chemoimmunotherapy or that has relapsed after frontline chemoimmunotherapy and are ineligible for hematopoietic stem cell transplantation because of age or comorbidities; or disease that is refractory or has relapsed after at least 2 lines of systemic therapy.3
Ciltacabtagene autoleucel (Carvykti), which is indicated for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy, including an IMiD, a PI, and an anti-CD38 monoclonal antibody4
Tisagenlecleucel (Kymriah), which is indicated for the treatment of patients 25 years of age and younger with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse; adult patients with relapsed/refractory LBCL who have received at least 2 prior lines of systemic therapy, excluding those with primary central nervous system lymphoma; and adult patients with relapsed/refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy5
Brexucabtagene autoleucel (Tecartus), which is indicated for the treatment of adult patients with relapsed/refractory mantle cell lymphoma and adult patients with relapsed/refractory B-cell precursor ALL6
Axicabtagene ciloleucel (Yescarta), which is indicated for the treatment of adult patients with LBCL that is refractory to frontline chemoimmunotherapy or that has relapsed within 12 months of frontline chemoimmunotherapy, as well as adult patients with relapsed/refractory LBCL who have received at least 2 prior lines of systemic therapy7
The FDA emphasizes that although the benefits of these products in their indicated uses continue to outweigh their potential risks, it is investigating the identified risk of T-cell malignancy, which may have serious outcomes, such as hospitalization and death.1 The agency is evaluating whether regulatory action pertaining to this risk is necessary.
All gene therapy products with integrating lentiviral or retroviral vectors, including CD19- and BCMA-directed genetically modified autologous T-cell immunotherapies, are labeled with a United States prescribing information class warning for the development of secondary malignancies. The initial FDA approvals of these products included postmarketing requirements per Section 505(o) of the Federal Food, Drug, and Cosmetic Act for investigators to conduct 15-year observational follow-up safety studies for the purpose of assessing the long-term safety profiles of these products and the risk of developing secondary malignancies after treatment.
Patients being treated with these CD19- and BCMA-directed genetically modified autologous T-cell immunotherapies should receive life-long monitoring for the development of new malignancies. If a patient develops a new malignancy after receiving treatment with these products, they should contact the respective product’s manufacturer to report the incident and receive instructions regarding the collection of patient samples that will be tested for the presence of the CAR transgene.
Suspected AEs, including T-cell malignancies, related to these products can be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Health care providers, clinical investigators, caregivers, and patients with questions about these products can contact the FDA’s Center for Biologics Evaluation and Research at ocod@fda.hhs.gov.
References
FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies. News release. FDA. November 28, 2023. Accessed November 29, 2023. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-t-cell-malignancy-following-bcma-directed-or-cd19-directed-autologous
Abecma. Prescribing information. Bristol-Myers Squibb; 2021. Accessed November 29, 2023. https://packageinserts.bms.com/pi/pi_abecma.pdf
Breyanzi. Prescribing information. Bristol-Myers Squibb; 2022. Accessed November 29, 2023. https://www.fda.gov/media/145711/download
Carvykti. Prescribing information. Janssen Biotech; 2023. Accessed November 29, 2023. https://www.fda.gov/media/156560/download
Kymriah. Prescribing information. Novartis; 2022. Accessed November 29, 2023. https://www.fda.gov/media/107296/download
Tecartus. Prescribing information. Gilead; 2021. Accessed November 29, 2023. https://www.fda.gov/media/140409/download?attachment
Yescarta. Prescribing information. Gilead; 2022. Accessed November 29, 2023. https://www.fda.gov/media/108377/download
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FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
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November 28, 2023
Summary of the Issue
The Food and Drug Administration (FDA) has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or postmarketing adverse event (AE) data sources.
FDA has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. T-cell malignancies have occurred in patients treated with several products in the class. Currently approved products in this class (listed alphabetically by trade name) include the following:
Abecma (idecabtagene vicleucel)
Breyanzi (lisocabtagene maraleucel)
Carvykti (ciltacabtagene autoleucel)
Kymriah (tisagenlecleucel)
Tecartus (brexucabtagene autoleucel)
Yescarta (axicabtagene ciloleucel)
Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action.
As with all gene therapy products with integrating vectors (lentiviral or retroviral vectors), the potential risk of developing secondary malignancies is labeled as a class warning in the U.S. prescribing information (USPIs) for approved BCMA-directed and CD19-directed genetically modified autologous T cell immunotherapies. The initial approvals of these products included postmarketing requirements (PMRs) under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to conduct 15-year long term follow-up observational safety studies to assess the long-term safety and the risk of secondary malignancies occurring after treatment.
Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies. In the event that a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the Chimeric Antigen Receptor (CAR) transgene.
To report suspected adverse events including T cell malignancies, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Healthcare providers, clinical investigators, patients, and caregivers who have questions may contact FDA’s Center for Biologics Evaluation and Research (CBER) at ocod@fda.hhs.gov.
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https://www.drugoffice.gov.hk › healthcare_providers
Nov 29, 2023 — The United States: FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen ...
Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers
CMS (.gov)
https://www.cms.gov › view › ncacal-decision-memo
A. The Centers for Medicare & Medicaid Services (CMS) proposes to cover autologous treatment with T-cells expressing at least one chimeric antigen receptor ...
FDA Alerts To Major Risk Of T-cell Malignancy In BCMA- ...
TruLaw
https://trulaw.com › FDA
Dec 13, 2023 — ... malignancies is in place for authorized BCMA-directed and CD19-directed genetically modified autologous T cell immunotherapies. Consumers ...
CAR T Cells: Engineering Immune Cells to Treat Cancer
National Cancer Institute (.gov)
https://www.cancer.gov › treatment › research › car-t...
Mar 10, 2022 — Dozens of targeted therapies are now standard treatments for many cancers. And over the past decade, immunotherapy—therapies that enlist and ...
Missing: death, ?| Show results with: death,
FDA Reports Hospitalizations & Deaths Linked to CAR-T ...
Trial Site News
https://www.trialsitenews.com › fda-reports-hospitaliz...
Nov 29, 2023 — ... malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies.
CAR-T cell therapy for hematological malignancies
ScienceDirect
https://www.sciencedirect.com › science › article › pii
T cell malignancies, with serious outcomes, including hospitalization and death, following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. from www.sciencedirect.com
by C Wang · 2023 — Novartis' Kymriah, a CD19-directed genetically modified autologous T-cell immunotherapy, was the first CAR-T cancer immunotherapy to reach the U.S. market ...
Safety and clinical efficacy of BCMA CAR-T-cell therapy in ...
Journal of Hematology & Oncology
https://jhoonline.biomedcentral.com › articles
by G Roex · 2020 · Cited by 102 — Recently, chimeric antigen receptor (CAR)-T-cell immunotherapy has entered the clinical trial arena [6, 7]. CAR-T cells are autologous ...
CAR T-Cell Therapy in Hematologic Malignancies
ASCO Publications
https://ascopubs.org › doi › EDBK_320085
by S Gill · 2021 · Cited by 48 — At the time of writing, five anti-CD19 CAR T-cell products are approved by the U.S. Food and Drug Administration for seven different ...
Prolonged hematological toxicity in patients receiving ...
Frontiers
https://www.frontiersin.org › fimmu.2022.1019548
by H Li · 2022 · Cited by 6 — ... BCMA/CD19 CAR-T-cell therapy for ... following treatment with chimeric antigen receptor T cells in patients with hematologic malignancies.
FDA investigating risk of secondary cancers after CAR-T ...
CNN.com
https://www.cnn.com › 2023/11/29 › health › car-t-ther...
Nov 29, 2023 — ... BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. ... T therapy requires genetic modification of T cells ...
FDA Investigates T-Cell Malignancy Risk Linked to CAR T- ...
LinkedIn · Biopatrika
4 reactions · 1 month ago
... directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. ... to severe outcomes, including hospitalization and death ...
CAR T-cell immunotherapy of B-cell malignancy: the story so far
Sage Journals
https://journals.sagepub.com › doi
May 27, 2020 — Chimeric antigen receptor (CAR) T-cell immunotherapy has achieved unprecedented efficacy in the treatment of chemotherapy-resistant or ...
Sitero Addresses FDA Investigation of T-Cell Malignancy ...
Sitero
https://sitero.com › car-t-cell-risks-fda-investigation-su...
... treated with BCMA- or CD19-directed autologous CAR T-cell immunotherapies. ... The reported serious outcomes have included hospitalization and death. What are ...
FDA probing serious risk of T-cell malignancies in CAR- ...
Seeking Alpha
https://seekingalpha.com › news › 4040765-fda-investi...
Nov 28, 2023 — ... treated with CAR-T cell immunotherapies directed ... BCMA-directed and CD19-directed genetically modified autologous T-cell immunotherapies.
65th ASH Annual Meeting & Exposition: Author Index A
The Conference Exchange
https://ash.confex.com › ash › webprogram › authora
Ackermann, J. 3787 - Impact of Sex on Clinical Outcomes after CD19 CAR T-Cell Therapy for Large B-Cell Lymphoma: Response and Survival Are ...
Chimeric Antigen Receptor-T Cell Therapy
Lippincott Williams & Wilkins
https://journals.lww.com › hemasphere › fulltext › chim...
by J Buechner · 2018 · Cited by 51 — The technology and strategy of using autologous, genetically modified, and adoptively transferred T cells for individualized cancer treatment differs ...
FDA-approved CAR T-cell Therapies
UPMC Hillman Cancer Center
https://hillman.upmc.com › ... › CAR T-Cell Therapy
... genetically modified T cells to find and kill cancer. UPMC Hillman Cancer Center was ... cell lymphoma after two or more lines of systemic therapy, including:.
About CARVYKTI
carvyktihcp.com
https://www.carvyktihcp.com › about-carvykti
CARVYKTI® (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the ...
Respiratory Viral Infections in Recipients of Cellular Therapies
Oxford Academic
https://academic.oup.com › ofid › article › ofad166
by R Wilson Dib · 2023 · Cited by 2 — ... cells targets cancer cells by recognizing their tumor-associated antigens [4]. CAR T-cell therapies directed against CD19 are being used in the treatment of ...
Management of adults and children receiving CAR T-cell ...
Annals of Oncology
https://www.annalsofoncology.org › article › fulltext
by PJ Hayden · 2022 · Cited by 165 — Kinetics and biomarkers of severe cytokine release syndrome after CD19 chimeric antigen receptor-modified T-cell therapy. Blood. 2017; 130 ...
Risk of Infections with Chimeric Antigen Receptor T-Cell ...
Transplantation and Cellular Therapy
https://www.astctjournal.org › article › fulltext
by J Meir · 2021 · Cited by 29 — Owing to differential expression patterns on the B cell surface, CAR-T therapy targeting CD19 will likely result in more bacterial infections, ...
Facts About Chimeric Antigen Receptor (CAR) T-Cell ...
Leukemia & Lymphoma Society
https://www.lls.org › sites › default › files › FS...
PDF
The first 2 autologous CAR T-cell therapies, tisagenlecleucel (Kymriah®) and axicabtagene ciloleucel (Yescarta®), were approved by the US Food and Drug ...
FDA on Risk of Secondary Secondary T-Cell Malignancy ...
HMP Global Learning Network
https://www.hmpgloballearningnetwork.com › news
Dec 5, 2023 — ... (BCMA)- or CD19 genetically modified autologous CAR T-cell immunotherapies, specifically. ... malignancy-following-bcma-directed-or-cd19-directed ...
Clinical Lessons from Chimeric Antigen Receptor-T Cells
Mary Ann Liebert
https://www.liebertpub.com › doi › full › hum.2021.173
by M Irving · 2021 · Cited by 41 — The successful translation of CAR-T cell therapy to other tumor types, including solid tumors, is the next big challenge. As the field advances ...
CAR-T cell therapy for hematological malignancies
Frontiers
https://www.frontiersin.org › fimmu.2022.1019115
by J Huang · 2022 · Cited by 14 — In the past decade, the emergence of chimeric antigen receptor (CAR) T-cell therapy has led to a cellular immunotherapy revolution against ...
The EBMT/EHA CAR-T Cell Handbook
EBMT
https://www.ebmt.org › sites › default › files › 2...
PDF
by N Kröger · 2022 · Cited by 9 — Chimeric antigen receptor T cell therapy (CAR-T) is a new class of medicinal prod- ucts that are genetically engineered from T cells. It is ...
Pharmacology of Chimeric Antigen Receptor–Modified T ...
Annual Reviews
https://www.annualreviews.org › doi › annurev-pharmt...
by EZ Song · 2021 · Cited by 11 — CAR-T cell therapies utilize genetically modified T cells to attack tumor cells in patients. They are based on the concept that engineered receptors consisting ...
FDA Warns of T-Cell Malignancy Risk Following ...
Precision Medicine Online
https://www.precisionmedicineonline.com › fda-warns...
Nov 29, 2023 — ... CD19-directed autologous cell treatments within clinical trials and in the post-market setting. The cell therapies flagged by the FDA include ...
FDA investigating risk of malignancy linked with CAR-T cell ...
The Pharma Letter
https://www.thepharmaletter.com › article › fda-investi...
Nov 29, 2023 — ... BCMA-directed and CD19-directed genetically modified autologous T cell immunotherapies. The initial approvals of these products included ...
Infectious complications in patients with relapsed refractory ...
ashpublications.org
https://ashpublications.org › bloodadvances › article › I...
Mar 29, 2022 — ... modified T-cell immunotherapy . Blood ... , et al. Late events after treatment with CD19-targeted chimeric antigen receptor modified T cells .
BCMA CAR-T cells in multiple myeloma–ready for take-off?
Taylor & Francis Online
https://www.tandfonline.com › ... › Latest Articles
by L Scheller · 2023 — Chimeric antigen receptor T cells (CAR-T) are genetically modified cells equipped with a new receptor to specifically recognize and destroy antigen-positive ...
Critical care management of chimeric antigen receptor T-cell ...
American Cancer Society Journals
https://acsjournals.onlinelibrary.wiley.com › doi › caac
by A Shimabukuro-Vornhagen · 2022 · Cited by 34 — CA: A Cancer Journal for Clinicians publishes information about the prevention, early detection, and treatment of cancer, ...
Chimeric Antigen Receptor T-Cell - an overview
ScienceDirect
https://www.sciencedirect.com › topics › chimeric-antige...
... cancer cells without actually genetically modifying them as in CAR-T cells. ... CAR-T cells directed against CD19 not only results in clearance of malignant ...
A deep insight into CRISPR/Cas9 application in CAR-T cell ...
Stem Cell Research & Therapy
https://stemcellres.biomedcentral.com › articles
by E Razeghian · 2021 · Cited by 78 — CAR-T cell therapy includes the genetic modification of patients' autologous T cells or allograft cells to efficiently express a CAR involving a ...
CAR T-Cell Therapy for Relapsed/Refractory Non-Hodgkin's ...
hematologyandoncology.net
https://www.hematologyandoncology.net › may-2022
by F St-Pierre · Cited by 10 — The development of CD19-specific chimeric antigen receptor (CAR) T-cell therapy has revolutionized treatment for patients who have R/R aggressive B-cell NHL, ...
More results
https://www.researchsquare.com/article/rs-3287211/v1
https://www.reddit.com/r/NWBO/comments/198skz4/nwbo_the_work_of_robert_prins_and_his_team/
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173627729
https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/
https://nwbio.com/video-dr-marnix-bosch-speaks-at-asco-2023/
https://nwbio.com/wp-content/uploads/NWBT_ASCO_slides_06032023_FINAL.pdf
https://smithonstocks.com/highly-probable-uk-approval-of-dcvax-l-in-1h-2024-would-be-a-crowning-achievement-for-northwest-biotherapeutics/
Why Dendritic Cell Vaccines Like DCVax-L Promise to be A Major Advance in Solid Cancer Therapy
The company’s press release of December 21, 2023 eloquently explains the reasoning that leads me to conclude that dendritic cell vaccines represent a novel, paradigm shifting approach to treating in not just GBM but all resectable solid tumors. I quote from the press release:
“One of the key factors making GBM so difficult to treat is that it is an extremely heterogeneous tumor. Accumulating evidence suggests that intratumor heterogeneity likely is the key to understanding treatment failure in GBM (Sottoriva, PNAS, 2013). Another key challenge is that as GBM develops, it induces an immunosuppressive microenvironment which compounds the difficulty of mounting an effective immune response against the tumor - especially within the central nervous system, which is an immune privileged space behind the blood brain barrier.
DCVax-L is designed to address both of these key challenges. As the Company previously reported, proteomic studies have demonstrated that a single tumor lysate sample contained tens of thousands of different peptides and, out of this pool, the dendritic cells selected, processed and presented over 600 different peptides (tumor targets) to T cells. T cell studies (TCR sequencing and T cell clonal expansion assays) analyzing the breadth and strength of T cell response following DCVax-L treatment have found extensive responses, including clonal expansion of up to 800 T cell clones at month 4 and up to 1200 T cell clones at month 8 in the samples studied. Each T cell clone focuses on a particular and distinct target. In individuals not being treated with the vaccine, only 2 – 20 new T cells clones are seen between month 4 and month 8.
The results of these proteomic, T cell and other studies provide support for what the Company believes to be the mechanism of action of DCVax-L: i.e., mobilizing a broad spectrum and strong de novo T cell response that addresses the extensive heterogeneity of GBM and overcomes the immunosuppressive microenvironment around the tumor.
The Company believes that this mechanism of action will be applicable for most types of solid tumors. Solid tumors comprise approximately 90% of all cancers, and a key difficulty that other treatment approaches have encountered with solid tumors is their heterogeneity.
The Company has already had positive results with DCVax-L in some compassionate use cases with other diverse solid tumors. The Company looks forward to building on its experience with DCVax-L in GBM and the compassionate use cases to address a wide range of other operable solid tumors.
The Company also had positive results in its Phase 1 trial of DCVax-Direct, in which more than a dozen diverse types of inoperable solid tumors were treated. DCVax-Direct involves essentially the same mechanism of action as DCVax-L, except that the tumor target proteins are taken up by the dendritic cells in situ in the tumor following intra-tumoral injection, rather than from tumor lysate from a surgically resected tumor tissue sample. The Company looks forward to resuming its clinical development of DCVax-Direct for a wide range of inoperable solid tumors.” (Note that the underlining for emphasis is mine.)
https://twitter.com/AllenTurner206?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1625866069780070401%7Ctwgr%5Ef63c5686b065b5071c66f18f79c23977002be4ca%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Finvestorshub.advfn.com%2Fboards%2Fread_msg.aspx%3Fmessage_id%3D173678492
https://www.researchsquare.com/article/rs-3287211/v1
https://www.reddit.com/r/NWBO/comments/198skz4/nwbo_the_work_of_robert_prins_and_his_team/
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173627729
https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/
https://nwbio.com/video-dr-marnix-bosch-speaks-at-asco-2023/
https://nwbio.com/wp-content/uploads/NWBT_ASCO_slides_06032023_FINAL.pdf
Impressive LCM strategy before initial approval! #dcvax $nwbo
— Allen Turner (@AllenTurner206) February 15, 2023
DCVax-L + Poly-ICLC. Est primary completion Jan 2024. Unpublished interim results: ~50% survival at >8 YEARS.
DCVax-L + PD-1. Est primary completion Aug 2024. Unpublished interim results: ~65% survival at >26 mos. pic.twitter.com/T0jAwH65Uo
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://www.researchsquare.com/article/rs-3287211/v1
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173627729
https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/
https://nwbio.com/video-dr-marnix-bosch-speaks-at-asco-2023/
https://nwbio.com/wp-content/uploads/NWBT_ASCO_slides_06032023_FINAL.pdf
Impressive LCM strategy before initial approval! #dcvax $nwbo
— Allen Turner (@AllenTurner206) February 15, 2023
DCVax-L + Poly-ICLC. Est primary completion Jan 2024. Unpublished interim results: ~50% survival at >8 YEARS.
DCVax-L + PD-1. Est primary completion Aug 2024. Unpublished interim results: ~65% survival at >26 mos. pic.twitter.com/T0jAwH65Uo
Re: Guzzi62 post# 665942
Monday, January 22, 2024 3:22:46 PM
Post#
666113
of 666142
This has already been discussed, but here are some of my previous thoughts.
I just want to make one more point on the Elios tlpo versus tlpodc phase ii disease free melanoma trial and show you how they are working like Novocure does. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10401209/
Look at the link/figure below. Now realize that based upon this, they’re currently saying, well since tlpo and tlpodc are essentially equal, we should do a phase iii on tlpo because we can’t really afford to keep trialing tlpodc.
But wait a minute, look at cases at risk at thirty and 36 months.🤨 By 36 months, which is what they go by in their trial “survival section,” only one, that’s right, one data point was used to get their survival number for tlpo.😬 But look, they matured the tlpodc group and let 19 cases be at risk for the 36 month analysis.
You see what they did there? They didn’t bother to build a DC manufacturing base like NWBO, so apparently they said fck it, let’s just get one good 36 month data point and call it a day, so that we don’t have to build up an industry. (They also only had six tlpo data points at 30 months)
(Note: remember the Elios (Orbus Therapeutic’s parent) trial was for melanoma)
https://www.ncbi.nlm.nih.gov/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Click%20on%20image%20to%20zoom&p=PMC3&id=10401209_jitc-2023-006665f02.
Anything else recently published that qualifies to be listed with the manuscripts below ?
https://www.reddit.com/r/NWBO/comments/19ba83u/nwbo_how_northwest_biotherapeutics_succeeded_in/?rdt=55151&onetap_auto=true
https://www.reddit.com/r/NWBO/comments/198skz4/nwbo_the_work_of_robert_prins_and_his_team/
https://www.reddit.com/r/NWBO/comments/1603vv0/the_american_system_profits_over_life_nwbos/
https://drive.google.com/file/d/1zr8aHIN5ZZLO9wBf4HlJTc-C-mfajb0w/view
https://smithonstocks.com/highly-probable-uk-approval-of-dcvax-l-in-1h-2024-would-be-a-crowning-achievement-for-northwest-biotherapeutics/?co=northwest-biotherapeutics
https://smithonstocks.com/could-there-have-been-hundreds-of-millions-or-even-more-than-a-billion-counterfeit-shares-of-northwest-biotherapeutics-created-through-illegal-naked-shorting/
https://t.co/ZhGShsoxUlhttps://t.co/MTNivDXzFu$nwbo @alphavestcap Will the Nature
— alphavestcapital.com (@alphavestcap) January 22, 2024
Pre Print, when published, canonize the new SOC survival for ndGBM-rGBM from today's 16.5 months to 50% given the expectation to live 7-10 years with DC VAX L ?https://t.co/Sn9liYLIap
flipper44
Member Level
Re: None
Monday, January 22, 2024 7:43:58 AM
Post#
665970
of 665992
Already here.
Tony Blair’s institute for global change one day envisions BioNTech being a solution with its MRNA cancer vaccine approach.
That said, he needs to understand what he vaguely refers to as a BioNtech “generic” off the shelf broad spectrum cancer vaccine needing to lead the way is illusory, because BioNTech is just barely into phase ii, and their technology is god awful expensive and cumbersome.
What he does not understand is that DCVax-l is already here. This already personalized vaccine is not off the shelf, but tailored and far more broad spectrum than anything BioNtech has —even at the conception stage.
For long timer’s here, let’s take a brief look at BioNTech’s forthcoming uphill climb.
First, as Dr. Bosch might caution, BioNTech is back to the trade of thinking they are already smart enough to identify all the right antigens from a person’s tumor. Just like Dr. Allison’s Neon, and other precursor attempts. Granted, BionTech might select a few more antigens than the other companies before them, but already, in phase I, there are signs that each trial phase will diminish in response.
Second, let’s look at what BioNTech does after they select what they believe to be the correct neoantigens from a patient’s tumor.
“The vaccine is infused into a person’s bloodstream. In some patients it can cause immune cells called dendritic cells to make the neoantigen proteins. And in some cases, the dendritic cells also train the rest of the immune system, including T cells, to recognize and attack tumor cells that express these same proteins. With the T cells on high alert to destroy cells bearing these proteins, the cancer may have a lower chance of returning.”
https://www.mskcc.org/news/can-mrna-vaccines-fight-pancreatic-cancer-msk-clinical-researchers-are-trying-find-out
Long in tooth investors on this board recall Argos’ attempts at an mRNA cancer vaccine wherein they electroplated about 15 antigens’ mRNA coding into a patient’s dendritic cells, so that the dendritic cells could make and express said antigen fragments. Here again, Argos thought they had selected enough antigens, and that they were smart enough to pick the right ones. They also inserted two cumbersome and unnatural steps into the process — electroporation and mRNA induced cellular antigen re-manufacturing.
It didn’t work.
Now BioNTech thinks they can select the right antigens, but as you see above, instead of electroplating the antigens into dendritic cells, they are simply hoping “in some cases” it can cause dendritic cells in the body to uptake and make the antigens BionTech selected, and then hope “in some cases” that some dendritic cells will express BioNTech’s human selected antigens to t-cells.
Just in theory, it’s more hope based than Argos.
Anyway, back to the Tony Blair institution recognizing that before technically convoluted (my words) and expensive therapies can make their way onto the stage, we urgently need to use a broad spectrum cancer vaccine. Any guesses what it should be?
Spoiler alert. DCVax-l. In many expert opinions.
Mr.Blair is also hopeful the (swift) process speeds up maa application reviews. (That 10 million pound infusion to the MHRA to move high impact therapies, like “cancer vaccines” to the commercial market in 2024.)
Unfortunately, Mr. Blair wants to turn that money into a slow foot dragging effort, only to have its speed ready and available when BioNtech’s cumbersome boondoggle gets to third base. (Even BioNTech admits their technology, if successful, will not get to commercialization for several years.)
Fortunately, Mr.Blair’s BioNTech advocacy is not the UK’s near term plan. Patients can see real improvement once the MHRA expectedly approves DCVax-l, imo. It has everything Mr. Blair dreams of.
1. Personalized Cancer Vaccine.
2. Incredibly Safe. Perhaps the safest cancer therapy ever devised.
3. Reasonable costs expected to lower even further once full scale closed system automation takes hold.
4. Plus it has the additional advantage of synergy with other immunotherapeutic.
It’s already here Mr. Blair.
NWBO
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TDD:
Here's the link to the ChatGBT correspondance. Please do indulge me, where I buried its response to my question.
https://chat.openai.com/share/ddc9aa99-25f1-4c91-a964-d9a03d5ed16f
Please do correlate the word for word response.
And going forward, please incorporate any evidence for accusations when raising them, so that we can waste as little time as possible.
And how is it, you never seem to question the nonsense of Ex, LC, Legend, icnothing and the like? Their bias correlates with your own?
Gilead’s Trodelvy Fails to Improve Survival in Lung Cancer (1)
Gilead’s Trodelvy Fails to Improve Survival in Lung Cancer (1)
Company will see if some patients may still benefit from drug
Stock falls in premarket trading after study results releasedBy Madison Muller
(Bloomberg) -- Gilead Sciences Inc.’s Trodelvy failed to significantly improve survival in a trial of patients with advanced lung cancer, a blow to the targeted treatment that’s in one of the most promising classes in oncology.
Patients getting Trodelvy didn’t live significantly longer than those getting chemotherapy alone, the Foster City, California-based company said Monday in a statement. Gilead said it plans to discuss the results with regulators and will work to identify whether there are certain lung cancer patients who may still benefit from the drug.
The stock fell 8.4% at 8:37 a.m. in early New York trading. The shares had gained about 8% to start the year.
Already approved to treat some types of breast cancer and bladder cancer, Trodelvy is an antibody-drug conjugate, a medication that directly delivers strong tumor-killing doses while minimizing damage to surrounding tissues. Excitement about ADCs runs high, with big drugmakers making deals to acquire them. But another ADC similar to Trodelvy being developed by AstraZeneca Plc and Daiichi Sankyo Co. fell short of expectations last year in lung and breast cancer patients.
Gilead’s trial included 603 patients with advanced non-small cell lung cancer who didn’t respond to other treatments like chemotherapy or checkpoint inhibitors. There was a numerical improvement in overall survival among patients with common subtypes of non-small cell lung cancer who got Trodelvy, the company said. The drug’s safety profile was consistent with prior studies.
There was a difference of more than three months in overall survival in favor of Trodelvy in a sub-group of patients who hadn’t responded to prior immunotherapy, which Gilead plans to study. The drugmaker will present data from the study at an upcoming medical meeting.
“The need for effective treatments remains urgent,” Chief Medical Officer Merdad Parsey said in the statement.
Deals for makers of ADCs and their drugs include Johnson & Johnson’s agreement to pay $2 billion for Ambrx Biopharma Inc., AbbVie Inc.’s $10.1 billion deal for ImmunoGen Inc. and Merck & Co.’s agreement to pay as much as $22 billion for the rights to sell three experimental ADCs from Daiichi Sankyo.
dstock07734
Absolutely! No other companies have the treatments that can trigger the same magnitude of anti-tumor response as NWBO's DCVax-L. This company on the news would not pose any competition to NWBO either.
IMO, Merck could be among the ones that have been suppressing the news coverage of NWBO until the time is right for Merck. Which company could force AI to take down Dr. Liau's webinar video twice? Only the most relevant one.
As the Company previously reported, proteomic studies have demonstrated that a single tumor lysate sample contained tens of thousands of different peptides and, out of this pool, the dendritic cells selected, processed and presented over 600 different peptides (tumor targets) to T cells. T cell studies (TCR sequencing and T cell clonal expansion assays) analyzing the breadth and strength of T cell response following DCVax-L treatment have found extensive responses, including clonal expansion of up to 800 T cell clones at month 4 and up to 1200 T cell clones at month 8 in the samples studied. Each T cell clone focuses on a particular and distinct target. In individuals not being treated with the vaccine, only 2 – 20 new T cells clones are seen between month 4 and month 8.
The results of these proteomic, T cell and other studies provide support for what the Company believes to be the mechanism of action of DCVax-L: i.e., mobilizing a broad spectrum and strong de novo T cell response that addresses the extensive heterogeneity of GBM and overcomes the immunosuppressive microenvironment around the tumor.
https://classic.clinicaltrials.gov/ct2/show/NCT02301611?cond=NCT02301611&draw=2&rank=1
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7914039/pdf/10434_2021_Article_9709.pdf
The Danish Dude : Can you amplify "back in review status again"? Thanks.A.E.K.
Re: biosectinvestor post# 665890
Sunday, January 21, 2024 5:48:26 PM
Post#
665908
of 665950
I look very much forward to the published version of Robert Prins et al article in Nature Portfolio about the Dcvax-l and poly-iclc, now it is back in review status again.
Have run for 14 years in parallel with the P3 trial and look at the estimated completion date.
I'll be darned.
Under 10 days.
Has the Nature Preprint had a processing change recently? How long until publication?
"Status:
Under Review"
https://www.researchsquare.com/article/rs-3287211/v1
https://www.reddit.com/r/NWBO/comments/16jm3ig/groundbreaking_phase_ii_trial_on_gliomas_unveils/?utm_source=share&utm_medium=web2x&context=3
https://www.reddit.com/r/NWBO/comments/19ba83u/nwbo_how_northwest_biotherapeutics_succeeded_in/?rdt=55151&onetap_auto=true
https://www.reddit.com/r/NWBO/comments/198skz4/nwbo_the_work_of_robert_prins_and_his_team/
https://www.reddit.com/r/NWBO/comments/19ba83u/nwbo_how_northwest_biotherapeutics_succeeded_in/?rdt=55151&onetap_auto=true
https://www.reddit.com/r/NWBO/comments/198skz4/nwbo_the_work_of_robert_prins_and_his_team/
$NWBO
— 🇩🇰 The Danish Dude 🇩🇰 (@FlemmingBruce) January 21, 2024
Do you know the DCVax-L - poly-iclc combo trial that has an article about it in review at Nature Portfolio and which has run for 14 years now, has an estimated primary completion date next week? pic.twitter.com/Tsd3V55Zvm
dstock07734
Re: theorysuit post# 665767
Sunday, January 21, 2024 12:18:17 PM
Post#
665806
of 665808
Read the following and fill up your mind with real genuine science to ebb away the nonsense in your mind.
Purpose: Autologous tumor lysate-pulsed dendritic cell (DC) vaccination has shown promising long-term survival in a cohort of patients with newly diagnosed glioblastoma. The purpose of this study was to better understand the mechanisms and modulation of the immune microenvironment underlying the clinical efficacy of DC-based vaccine therapy. Experimental Design: We performed bulk RNA sequencing on tumor samples from patients with newly diagnosed glioblastoma obtained prior to treatment with dendritic cell vaccination. We characterized the molecular mechanisms and immune microenvironments of long-term survivors (LTS, n= 8), medium-term survivors (MTS, n= 13), and short-term survivors (STS, n = 17). Results: There was an enrichment of the mesenchymal subtype of glioblastoma in the long-term survival group. Additionally, decreased tumor cell density, upregulation of cell surface markers, and increased neuronal activity were associated with the longer survival cohorts. Two microglia populations, one associated with increased survival and one associated with decreased survival in the DC-treated cohorts, but not standard of care (SOC) cohorts, are also potentially implicated in response to DC immunotherapy. There were increases in functional activity of the immune environment in longer survivor cohorts. Conclusions: These analyses suggest the potential to identify tumor-based predictive factors that may be associated with favorable responses to DC vaccination in glioblastoma patients; and if validated, these findings may enable better patient selection for future clinical trials.
https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE249282
Aiguo Li, PhD (Biologist)
https://ccr.cancer.gov/neuro-oncology-branch/clinical-team/neuro-oncology-branch-teams
Krishnan R. Patel
https://ccr.cancer.gov/staff-directory/krishnan-r-patel
Bharati Mehani Postdoctoral Fellow at NCI-NIH | Cancer Genomics | Epigenetics | Single-cell RNA Seq | Tumor Microenvironment | Brain Transcriptomics
https://www.linkedin.com/in/bharatimehani/
Nicole Briceno (Biologist)
https://ccr.cancer.gov/neuro-oncology-branch/clinical-team/neuro-oncology-branch-teams
Kai Wang
https://www.med.upenn.edu/apps/faculty/index.php/g275/p8133343
Kenneth Aldape
https://ccr.cancer.gov/staff-directory/kenneth-aldape
Eytan Ruppin
https://ccr.cancer.gov/staff-directory/eytan-ruppin
Emma Billingslea-Yoon
https://www.uclahealth.org/providers/emma-billingslea-yoon
Robert M. Prins
https://www.uclahealth.org/departments/neurosurgery/research/research-scientists/robert-m-prins-phd
Mark Gilbert, M.D.
https://ccr.cancer.gov/staff-directory/mark-r-gilbert
Linda Liau
https://www.uclahealth.org/cancer/members/linda-liau
https://www.reddit.com/r/NWBO/comments/1603vv0/the_american_system_profits_over_life_nwbos/
https://www.reddit.com/r/NWBO/comments/198skz4/nwbo_the_work_of_robert_prins_and_his_team/
"DCVax-L is currently being used in two ongoing combination trials. One UCLA trial involves DCVax-L combined with poly-ICLC.[21] This is for nGBM and rGBM and unpublished data is showing approximately 50% overall survival at 100 months.[22] Another trial involves DCVax-L, poly-ICLC and Keytruda.[23] This trial is for rGBM and unpublished data is showing approximately 60-65% survival at 800 days (Figure 1).[24]"
https://www.researchsquare.com/article/rs-3287211/v1
https://www.reddit.com/r/NWBO/comments/16jm3ig/groundbreaking_phase_ii_trial_on_gliomas_unveils/?utm_source=share&utm_medium=web2x&context=3
4 mo. ago
Thanks for your informed input on this Bio, much appreciated!
IMO this tees up things nicely for a partnership announcement with MRK before the end of the year. The paper even mentions that the next phase of this investigation is "initiated" with this combination herein plus Keytruda: "In fact, we have now initiated a phase I trial combining ATL-DC+Poly-ICLC with pembrolizumab in recurrent glioblastoma patients (NCT04201873)."
They might use the language 'initiated', but the fact of the matter is that this DCVax + Poly ICLC + PD-1 (Keytruda) has already been going strong now for at least +32 months. The unpublished results at 26 months were showing a ~65% SURVIVAL for RECURRENT GBM patients, which is absolutely staggering! 65% SURVIVAL for RECURRENT GBM!!!
exwannabe:Probably 99.999%, because if you or I get gbm tomorrow , with SOC, we sleep with the fishes (
$NWBO
— hoffmann6383 (@hoffmann6383) January 17, 2024
The American System - Profits Over Life; A Tiny Biotech's Battle to Bring a Cancer Vaccine to Market
Posted over at r/Wallstreetbets with MAA submission updates: https://t.co/GKVBJ6Iqxq
learningcurve2020:Shares sold by Malik a month ago were less than 1% of his holdings.Had to do it for a tax bill.A.E.K.
Re: None
Sunday, January 21, 2024 12:05:27 PM
Post#
665801
of 665801
Did we ever figure out how Malik had all those shares to sell?
http://www.otcmarkets.com/otcapi/company/financial-report/369942/content
If anyone is interested then please take a read of my NWBO 2023-24 Catalyst List here:
https://www.reddit.com/r/NWBO/comments/16ipzhq/nwbo_catalyst_list_update_202324/?utm_source=share&utm_medium=web2x&context=3
I also conducted a deep dive 55 page Synopsis on NWBO and DCVax which can be downloaded in PDF form from Google Drive here:
https://drive.google.com/file/d/1zr8aHIN5ZZLO9wBf4HlJTc-C-mfajb0w/view?usp=share_link
Any questions feel free to pm or dm me. Thanks
$NWBO lawsuit against market makers and upcoming MHRA application
Discussion
Northwest Biotherapeutics (NWBO) is making headlines due to its lawsuit against market makers, which includes the scumbag firm Citadel, and its forthcoming Marketing Authorization Application (MAA) submission to the Medicines and Healthcare products Regulatory Agency (MHRA). This dual development is exciting af for those of us that have been following this stock and it lead vaccine candidate DCvax that treats glioblastoma (GBM), an aggressive cancer with low survival rates.
The Lawsuit Against Market Makers: NWBO's lawsuit alleges market manipulation and interference in the trading of its stock. Citadel, a well-known market maker, is one of the entities named in NWBO's lawsuit. NWBO contends that certain market makers engaged in unethical practices that negatively impacted the company's stock price and trading volume.
The outcome of this lawsuit will likely have significant implications for NWBO and may set a precedent for how companies address alleged market manipulation. It highlights the ongoing debate about the transparency and fairness of financial markets, especially in the context of emerging biotechnology companies.
NWBO's Upcoming MAA Application to MHRA: In a separate development, NWBO is preparing to submit a Marketing Authorization Application (MAA) to the Medicines and Healthcare products Regulatory Agency (MHRA). The MAA is a critical step in the process of seeking approval for a pharmaceutical product in Europe. NWBO is seeking approval for its lead therapeutic candidates, dcvax.
Upon approval, dcvax will become accessible to patients in the European market and, in my opinion, will immediately bump SP over $3 per share.
NWBO's lawsuit underscores the importance of market integrity and fair practices, while its MAA application highlights the painstaking efforts required to bring novel therapies to patients in multiple jurisdictions.
As someone who has lost family and friends to GBM, I am eager for this vaccine to be made available globally. If their lawsuit exposes Kens crew for the scumbags they are than that will just be icing on the cake. It’s shocking that this stock isn’t front and center on WSB when you consider there is a multi year attack by market makers to ruin a small pharma company that is trying to upend the standard of care for an agressive form of cancer with low survival rates. Let that sink in……
On the suit, I have no opinion on the legal merits of it. But the thesis that spoofing explains the long term depressed stock price is weird, and it doesn't make sense to me. Spoofing is done to profit. Seems non-controversial. Market makers profit through trading; mainly spreads and execution fees. The ideal conditions for trading profits: 1) high activity, 2) high volatility and 3) wide spreads. The problem with the "spoofing = long term price suppression" thesis is that it would require market makers to act contrary to their own profit motive. NWBO typically trades (less than) a few million on an average day. It is surprisingly stable within a typical trading day, with a few notable exceptions. Spreads are typically fairly tight for an OTC stock. If someone wants to profit via spoofing, those are not desirable trading conditions. NWBO is trying to make a case for it. They might be able to make a very weak case for price suppression. I see no logical way to make a case for spoofing as the means to price suppression.
Also, as a reminder to people check out this meeting out from July 2019, which was a meeting of Brain Tumour Research, Member of Parliment Derek Thomas, and both Dr Navid Malik and Erik Ramos from NWBO:
https://www.braintumourresearch.org/media/news/news-item/2019/07/19/brain-tumours-discussed-at-meeting-with-health-minister
I found this particularly interesting:
"Dr Navid Malik of Northwest Biotherapeutics spoke of the need for Parliament to work with the Medicines and Healthcare products Regulatory Agency (MHRA) to modernise the clinical trial process, streamlining and reducing the number and length of trials required for at least an initial (“conditional”) approval for products with an established safety profile. This accelerated pathway would enable regenerative medicines that demonstrate safety and predict efficacy in small early-stage clinical trials to reach patients sooner."
NWBO have been working with these guys now for a long time and tomorrow we should know about whether the appointment of a champion might just be NWBO.
·
That might go to explaining the longer MIA time scales than many expected. If indeed this is true I think this would be massive news! The production ramp up will then be much quicker than anyone expect, and not only will resulting revenues be much higher much quicker but I suspect with the FW automation margins will also be superb!
tombaxers commented on An eye-opening FDA document relating to $NWBO DCVax Phase 3 trial design
Excellent work Bio, many thanks for this one! It really helps put a lot of the trial design FUD firmly to bed. As is becoming more & more clear the FDA have been on board with the DCVax trial likely from right back during pre-trial design stages. Linda and Linda made sure this trial was done by the book, hand in hand with the RAs and thus it took a long time in the making, but it is going to ensure this gets us across the finish post and ultimately to patients in need without the sort of fuckery that Dendreon was subject to with Provenge!
I dont think the patent portfolio and it's extent/ depth in covering the different aspects of IP has had any real detailed coverage to date and this is paramount to NWBOs ascent to the top and maintaining it's position there for years to come.
Would also be very interesting to hear how/ when you feel Flaskworks will go from prototype to a certified scalable production item which will allow NW Bio and it's CDMOs to move into the really big production numbers. As Elon always says, prototypes are easy, production is hard!
Calling all Reddit Army folk. On the premise that you all also f**king hate Ken Griffin and his band of shorts I kindly request that you take a look at what is going on at $NWBO in more detail.
The situation that NWBO have been up against in the public markets for years and years is nothing short of astounding and that they were able to survive this long and get their potentially revolutionary cancer treatment to the stage it is now (JAMA peer reviewed journal article backed up by 73 authors whom are a who’s who of Neuro-oncology) is even more incredible.
Furthermore, the level of deep involvement against NWBO blatantly includes Stat News; Novocure; Adam Feurstein and, less obviously a whole hareem of other paid bashers; probable big pharma competitors (who stand to loose a significant proportion of their chemo cash cows when NWBO's DCVax takes over their market share); major hedge funds and others.
A number of combination therapies using DCVax that are presently still being trialed but have not yet been PR’d are initially showing absolutely staggering results for the hardest to treat of all cancers, GBM and rGBM (see attached). 50% Overall Survival at 100 months in GBM is absolutely astonishing and with further tweaking is definitely coming close for the very first time to an actual Cancer CURE!
When all this goes down and the industry realises what NWBO hold (including an extensive patent portfolio in both the biology and manufacturing), the entire industry will be turned on it’s head and the resulting valuation of NWBO (if it has not been purchased outright by big pharma) will be staggering. Furthermore, after all is said and done - after court cases settle; short squeezes are over; effects on competitors is clear etc - the multifaceted ramifications in the financial markets is going to be huge!
You may just read into this that I am another pumper trying to get free press, but I have more in this than just my long position. I have experienced the destructiveness of cancer in multiple members of my family and the very fact these institutions are systematically trying to bankrupt a company that very likely holds a revolutionary step change in cancer treatment makes me sick to my stomach. I therefore urge you to do your own due diligence and investigate this further to see for yourselves exactly what is going on. If you would like any assistance in this regard then I would be happy to help direct you to some individuals who are far more versed in what is going on than me. A great place to begin your due diligence would be the NWBO iHub board and the following Twitter handles:
u/FlemmingBruce
u/hoffmann6383
u/rago_carlo
u/AlMusella
These guys all do very in depth due diligence. This is also a very god blog:
https://knowwhatyouhold.com/t/a-tale-of-many-trials/181
I look forward to your consideration of this!
Under IRP in the UK when DCVax-L gets marketing application approved, will
Northwest Biotherapeutics then be able to get DCVax-L approved by regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area) under IRP and witt new short Time horizons for authorisations, set at 60 to 110 days?
The Danish Dude
Re: exwannabe post# 665572
Friday, January 19, 2024 5:56:03 PM
Post#
665576
of 665671
So if you expect -L to approved by the MHRA under IRP then that means they first have to submit and get approved by some other RA
So you are now saying you misinterpret, what ought to be easily understood, even by a dane like me? Are you so desperate, that you hope for illiteracy to be your saviour? Well looking at your fud colleagues here, you maybe could have a point.
Try to read it again and take a new go at the written word.
Under IRP in the UK when DCVax-L gets marketing application approved, will
Northwest Biotherapeutics then be able to get DCVax-L approved by regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area) under IRP and witt new short Time horizons for authorisations, set at 60 to 110 days?
Did you see me write WHEN? That is WHEN DCVAX-L gets approved by MHRA THEN. So no, I do not personally assume us to be getting approved under IRP, but IRP will work for DCVAX-L afterwards.
Yes, it is possible that Northwest Biotherapeutics could get DCVax-L approved by regulators in Australia, Canada, Japan, Singapore, Switzerland, the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area) under the IRP and with new short time horizons for authorizations, set at 60 to 110 days
.
See?
That part said DCVax-L would get approved under IRP with other regulators. I assume after MHRA approval.
This is because the IRP is a regulatory pathway that allows for the expedited review of innovative therapies that have the potential to address unmet medical needs. The IRP is designed to be more efficient and flexible than traditional regulatory pathways, and it can help to accelerate the availability of new therapies to patients.
Nothing about DCVax-L getting approved under IRP pathway
In the case of DCVax-L, the IRP could be used to expedite the review of the marketing application for the drug in the UK. Once the marketing application is approved in the UK, Northwest Biotherapeutics could then use the IRP to seek approval for DCVax-L in other countries that participate in the IRP. This could potentially help to shorten the time it takes for DCVax-L to become available to patients in other countries.
I don't know if IRP in any way can expedite the review time with the MHRA. Flipper seems to believe a SWIFT protocol could have started in the UK by January 1st.
So if you expect -L to approved by the MHRA under IRP then that means they first have to submit and get approved by some other RA.As that has not happened, I guess you assume the present MAA will not be approved and we are waiting for a few years.
DD, when did you turn basher?
Games, must we .... as James Mason would've said.
You know as well as me, that you can only twist and turn my words here to get any kind of bullshit out of this your fud lot can have wet dreams about.
Bullish
BULLISH
ATL-DC=DCVax
flipper44
Member Level
Re: None
Saturday, January 20, 2024 11:05:04 AM
Post#
665663
of 665671
Bard likes poly-iclc with dendritic cell therapy
Poly-ICLC (Polyinosinic-polycytidylic acid-poly-l-lysine carboxymethylcellulose) administration can significantly impact dendritic cell therapy against cancer in several ways:
Activation and Maturation:
Toll-Like Receptor (TLR) 3 Agonist: Poly-ICLC acts as a ligand for TLR3, a receptor present on dendritic cells. This triggers signaling pathways within the dendritic cells, leading to their activation and maturation. Activated dendritic cells express higher levels of co-stimulatory molecules (CD80, CD86) and MHC (Major Histocompatibility Complex) molecules, enhancing their ability to antigen presentation and T cell priming.
Enhanced Cytokine Production: Poly-ICLC stimulates dendritic cells to produce pro-inflammatory cytokines like IL-12, IL-6, and TNF-a. These cytokines recruit and activate other immune cells like T cells and natural killer cells, further boosting the anti-tumor immune response.
Antigen Processing and Presentation:
Improved Antigen Uptake: Poly-ICLC can upregulate receptors responsible for antigen uptake (e.g., DEC-205) on dendritic cells, leading to increased internalization and processing of tumor antigens. This allows dendritic cells to present a broader range of tumor antigens to T cells, promoting a more diverse and effective anti-tumor response.
Cross-Presentation: Poly-ICLC can induce dendritic cells to cross-present tumor antigens, a process where internalized antigens are loaded onto MHC class I molecules for presentation to CD8+ cytotoxic T lymphocytes (CTLs). CTLs play a crucial role in directly killing tumor cells.
Migration and Homing:
Increased Chemotaxis: Poly-ICLC can induce the production of chemokines by dendritic cells, attracting other immune cells to the tumor site. This enhances the infiltration of T cells and NK cells into the tumor microenvironment, leading to localized anti-tumor activity.
Improved Lymphoid Homing: Poly-ICLC can upregulate adhesion molecules on dendritic cells, facilitating their migration to draining lymph nodes. This allows dendritic cells to efficiently interact with and prime T cells in the lymph nodes, generating a stronger systemic immune response against the tumor.
Overall, poly-ICLC administration in dendritic cell therapy enhances the cells' ability to effectively activate, mature, and present tumor antigens to the immune system. This leads to a more vigorous and targeted anti-tumor response, offering promising potential for cancer treatment.
However, it's important to note that research on poly-ICLC and its effectiveness in dendritic cell therapy is still ongoing. While clinical trials have shown promising results, further studies are needed to optimize its use and address potential side effects.
I hope this explanation helps! Please let me know if you have any further questions about poly-ICLC or dendritic cell therapy.
Re: skitahoe post# 665601
Friday, January 19, 2024 10:42:44 PM
Post#
665611
of 665671
Poly-ICLC brings the entire immune system to the fight once DCVax-L sets the targets. I do not expect that it will be any different for other cancers though it may work best with cancers that have some viral causes because Poly-ICLC triggers certain responses as though the body is under attack from viral RNA.
Poly-ICLC doesn't target cancers by itself however and there is little indication that it is effective by itself. They may want to partner with other companies too, as independent companies often want to do and Oncovir, just like NWBO and Merck would certainly have that right to do so. But it seems to work particularly well with DCVax-L and there are reasons for that - which is likely because of the number of targets, including viral targets that DCVax-L finds in brain tumors, and because Poly-ICLC is literally about raising the alarm bells with regard to defenses to viral antigens and targets. But it may also work with other antigens too, so that could be the difference with other tumors, if they do or do not have any indications of viral antigens. Certainly, side trials, and RWD would help a lot in discovering best applications of the combination. But also there could be cancers for which DCVax-L and Checkpoint inhibitors alone might be incredibly powerful together as well. And there could be some where entirely different combinations might work best based on particular targets for a given cancer or sub-group in a given cancer type.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
Re: meirluc post# 665608
Friday, January 19, 2024 10:38:50 PM
Post#
665610
of 665671
Poly-ICLC is an immune stimulant. It is injected separately, intramuscularly, into patients and that is where the proof of increased efficacy has been shown so far. It works by stimulating the body into thinking it is under attack by viruses. That's what it does.
It apparently raises the alarm throughout the body and brings all the DC's and certain other immune cells and stimulants throughout the body to bear on the alarm set by DCVax-L.
biosectinvestor
Member Level
Re: None
Friday, January 19, 2024 10:33:00 PM
Post#
665609
of 665672
Perspective On Long Drug Development Timelines $NWBO and $REGN Regeneron
It has been argued many times by shorts that a company developing a breakthrough drug for 20 or more years is unprecedented and really a sign of failure, not success, but this is simply not true. And for the cell therapy space, many of these treatments are literally LIVING DRUGS. They have not had an easy path to commercialization over many years but recent years have seen success. Technologies have improved, researchers and companies have improved the processes and technologies by which such drugs can be commercialized, and quite frankly, the entire notion is ahistorical and not at all consistent with history or scientific discovery.
Let me share this story below from the NYTimes. I'm going to just give the beginning part and a free access link for people to read it themselves. The main point is literally at the very beginning however. If the view of shorts held, Regeneron would not exist. But it's quite a successful company. So this argument is not a rule. Some people claim there are "rules" which is nonsense. Science, technology development and research follow their own paths and the notion that such absolute rules exist has been proven wrong repeatedly, especially with regard to certain not very bright commentators in this space.
Gift Link: https://www.nytimes.com/2011/11/21/business/eylea-a-vision-drug-wins-long-sought-approval.html?unlocked_article_code=1.PE0.IEZB.aNopTthUtqWA&smid=url-share
Success Long in Coming for Eylea, a Vision Treatment
By Andrew Pollack
Nov. 20, 2011
It has three Nobel Prize winners on its board. Its chairman, P. Roy Vagelos, is a pharmaceutical industry star who ran Merck during its heyday. Its chief scientist has written frequently cited biomedical papers.
Yet for all that, Regeneron Pharmaceuticals has known mostly failure in nearly 24 years of existence, piling up cumulative losses of $1.2 billion.
But that is now changing. Late Friday, the company won approval from the Food and Drug Administration for what is expected to be its first big drug — to treat the wet form of age-related macular degeneration, a leading cause of severe vision loss in the elderly.
For a year after approval, short's kept the share price FLAT for REGN. But Eylea was a blockbuster drug.
So shorts and manipulators can really hang on. But the reality is, they are frequently WRONG. They don't want you to know that, so they bring a lot of effort to fighting success no matter what. They work extremely hard to discourage longs and undermine confidence in companies and their management, no matter who they are, and no matter how competent they are... doesn't matter. Their job is to change the narrative and discourage interest. But the reality is, they often just flat out lie. Complexity is their friend, and the story for many of these companies and new technologies is filled complexity. They presume that investors like a simple story. So they relentlessly give a narrow, simple story of failure and work to keep the price low to affirm that they are right.
The reality is, we all hope to see a squeeze here. Imagine if we saw a squeeze like GME's.
Wouldn't that be something!
See Dumb Money - you'll enjoy it!
Short Trailer:
Long Preview:
Bullish
BULLISH
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
Re: skitahoe post# 665601
Friday, January 19, 2024 10:32:44 PM
Post#
665608
of 665672
Gary, I believe that Poly-ICLC is a maturation agent for DCVax (L and D) and therefore
should be as effective for other cancers as it is for GBM. OTOH, I am guessing that
the efficacy of DCVax itself may vary from one type of cancer to another and that may depend
on the extent, makeup and locations of the mutated cancerous antigenic moieties.
As for NWBO swallowing of Oncovir, I am all for it if the price tag is reasonable.
Bullish
BULLISH
$NWBO: How Northwest Biotherapeutics succeeded in distancing the competition.
June 2016 Northwest Biotherapeutics (NWBO) announced its Scientific Advisary Board 1).
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173665364
https://www.reddit.com/r/NWBO/comments/19ba83u/nwbo_how_northwest_biotherapeutics_succeeded_in/
https://twitter.com/FlemmingBruce/status/1748677097860588023
r/NWBO - $NWBO: How Northwest Biotherapeutics succeeded in distancing the competition.
"... comprised of leading experts in immunotherapies and oncology from both the U.S. and Europe."
The current members of the SAB is:Dr. Jerome Galon - Director of the Integrative Cancer Immunology Lab at INSERM (the French national institutes of health). He is associate Director and co-founder of European Academy of Tumor Immunology (EATI) and board Director of the Society for Immunotherapy of Cancer (SITC).
Dr. John Smyth - first Chair of Medical Oncology in Edinburgh and, over the course of 30 years, has developed multidisciplinary oncology to create the Edinburgh Cancer Research Centre,
And last but not least
Dr. Samir N. Khleif - Director of the Georgia Cancer Center, the State cancer center of Georgia at Augusta University. He is a Georgia Research Alliance Distinguished Cancer Scientist and Clinician, and a professor of Medicine, Biochemistry, Cancer Biology and Graduate Studies. He also serves as the Director of the Immuno-Oncology and Immunetherapeutics Program. Dr. Khleif previously served as Chief of the Cancer Vaccine Section at the National Cancer Institute (NCI), and Professor of Medicine at Uniformed Services University of the Health Sciences. He also served as a Special Assistant to the FDA Commissioner from 2006-2009, where he led the FDA Critical Path for Oncology designed to restructure the oncology drug development process.
In 2023 NWBO announced that Linda Liau had joined the SAB. 2)
In a new article 3) centered around Khleifs research into why immunotherapy wasn’t working, we learn about his focus on why some cancers become resistant to immunotherapy. His goal is to find ways to overcome this resistance. Despite immunotherapy's limitation, its effectiveness in some cases only works in about 15% of patients with advanced cancer. His research aims to improve this success rate by understanding and overcoming resistance. Not least is combination therapies where previous studies that combined immunotherapies with other treatments often failed due to a lack of understanding of their molecular interactions. Khleif's work concentrates on T-cells, which fight cancer. He studies how cancer cells evade the immune system and how checkpoint inhibitors can unleash T-cells against cancer.
Simultaneously to Khleifs work, Dr. Robert Prins of UCLA has for many years now researched into the efficacy of combination therapies and checkpoint inhibitors and not least, why it at times is not efficient and even fails.
A team under his lead has been researching into that and in researching Dr. Robert Prins' grants, we can correlate that work, with the grant in question 4)
r/NWBO - $NWBO: How Northwest Biotherapeutics succeeded in distancing the competition.
Let's look at the abstract of said grant.
The lack of effective glioblastoma treatments poses a significant health problem and highlights the need for novel and innovative approaches. Immunotherapy is an appealing strategy because of the potential ability for immune cells to traffic to and destroy infiltrating tumor cells in the brain. New information suggests that patients mounting immune responses after immunotherapy preferentially recognize novel neoantigens created by tumor-specific mutations. Our data, and that from other immunotherapeutic strategies for patients with cancer, suggest that the vast majority of tumor-specific T cells induced by such personalized, patient-specific immunotherapies do NOT recognize well-characterized, known antigens. Such information is consistent with recent data from other immune-responsive cancers, such as melanoma, in which the percentage of tumor-specific T cells recognizing known antigens was less than 1%. In order to design the most effective immunotherapeutic strategies for glioblastoma, we believe that it is critical to understand which antigens tumor-specific T cells recognize in this disease. Our hypothesis is that glioblastoma patients treated with immunotherapy will mount anti-tumor immune responses against specific mutations and splice variants in their individual tumors. Similarly, our other recent findings strongly suggest that the addition of PD-1 antibody (mAb) blockade to DCVax enhances both the intra-tumoral CD8+ T cell response and clinical benefit in pre-clinical studies. Furthermore, the timing of PD-1 mAb blockade is immunologically relevant; our unpublished, recent clinical trial results highlight how the neoadjuvant (prior to surgery) treatment with PD-1 mAb blockade induces enhanced anti-tumor immune responses and clinical benefit. We hypothesize that the addition of PD-1 mAb blockade should amplify the neoantigen-specific T cell response induced by DC vaccination, both in the blood and the tumor. To test these important questions, In Aim 1, we will develop a new bioinformatics pipeline to predict neoantigens that arise specifically from the types of genetic alterations that occur in GBM.
The teams work have been published in the following articles
Neoadjuvant anti-PD-1 immunotherapy promotes a survival benefit with intratumoral and systemic immune responses in recurrent glioblastoma 5)
Neoadjuvant PD-1 blockade induces T cell and cDC1 activation but fails to overcome the immunosuppressive tumor associated macrophages in recurrent glioblastoma 6)
Resolution of tissue signatures of therapy response in patients with recurrent GBM treated with neoadjuvant anti-PD1 7)
Immune checkpoint blockade induces distinct alterations in the microenvironments of primary and metastatic brain tumors 8)
Dendritic Cell Vaccination in Conjunction with a TLR Agonist Polarizes Interferon Immune Responses in Malignant Glioma Patients 9)
All this work correlates well with Dr. Khleifs research into the why's and if's of combination therapies being efficient or not and the last article in bold above, is currently in pre-print at Nature Portfolio and lay forward the results of combining DCvax-L with Poly-Iclc in a combination treatment, a clinical trial which NWBO have been running in parallel since 2014 with the DCVax-L phase 3 trial and which is estimated to finish this year.
The results can be said to be the pinnacle of the research currently being done into getting checkpoint inhibitors to work efficiently with DCVax-L. DCVax-L in PARTICULAR, since that has been not only the dendritic cell vaccine used by the UCLA during the Phase 3 trial, but also in Robert Prins and his teams work.
If you look at the abstract above, look at what is said about immunotherapies lack of recognizing known antigens.
DCVax-L counters over 11.000 antigens.
Pfizers and Modernas take on a cancer vaccine to be finish in a lower grade cancer, is 6-34 antigens.
You should definitely listen in to Dr. Marnix Bosch presentation of Mechanism of Action, in where he explains about how DCvax-L work with antigens 10).
r/NWBO - $NWBO: How Northwest Biotherapeutics succeeded in distancing the competition.
And then you ought to listen in to these presentations of Linda Liau during the last years of her speaking about the combination therapies of DCVax-L with poly-iclc and checkpoint inhibitors, in which even the titles are referring to "overcoming resistance".
Video 11)
r/NWBO - $NWBO: How Northwest Biotherapeutics succeeded in distancing the competition.
Video 12)
r/NWBO - $NWBO: How Northwest Biotherapeutics succeeded in distancing the competition.
Last but not least, you should listen in on the Al Musella webinar from December 2022, wherein Linda Liau explicitly removes all doubt, that ATL-DC used at UCLA is equivalent of NWBO's DCVax-L vaccine.
Video 13)
r/NWBO - $NWBO: How Northwest Biotherapeutics succeeded in distancing the competition.
The work that has been done by the like of Robert Prins and Dr. Khleif, has been incorporated as knowledge into the combination therapies of using DCvax-L with poly-iclc and Keytruda.
There is no doubt, that NWBO is not only ahead of the competition, but by quite a distance.
The quietness we, as retailers, have been suffering to endure for much too long, covers over efforts being done, of which we currently are left in a void to speculate about.
Don't let that fool you and don't let the extreme efforts done by market makers and a horde of fud on stock boards and social medias, let you having second thoughts about where this leads.
There is only one outcome and if anything, you should be encouraged about suppressing of the share price of NWBO. It is used to get shares cheap.
Dr. Khleifs disclosures are as follow
Khleif is an inventor on a patent application related to technology described. Khleif reports the following disclosures: stock and/or ownership interest in Georgiamune, Precision Immunotherapy, Ayala (formerly Advaxis), IO Biotechnology, PDS Biotechnology, KAHR Medical, Sandbox Inc., and Northwest Biotherapeutics. Khleif is an advisor to Aligos Therapeutics, Aummune, Bayer Consumer Care, FREE Foundation for Research & Education Excellence, GI Innovation, Incyte, Nectin TX, Northwest Biotherapeutics, RAPA Therapeutics, Sandbox Inc., Stemline Therapeutics Inc. Khleif reports research contracts with AstraZeneca and Bristol-Myers Squibb.
My disclosures:
I'm an retail nvestor in Northwest Biotherapeutics. I am not advising anyone to invest in NWBO. Do your own due diligence. The above is for your reading and viewing pleasure.
NWBO announces the members of the Scientific Advisary Board 2016
NWBO announces Linda Liau joining the SAB Advisary Board 2023
Understanding Immunotherapy Resistance Leads to New Therapeutic Strategies — and Hope
Dr. Robert Prins' grants
Perspective On Long Drug Development Timelines $NWBO and $REGN Regeneron
It has been argued many times by shorts that a company developing a breakthrough drug for 20 or more years is unprecedented and really a sign of failure, not success, but this is simply not true. And for the cell therapy space, many of these treatments are literally LIVING DRUGS. They have not had an easy path to commercialization over many years but recent years have seen success. Technologies have improved, researchers and companies have improved the processes and technologies by which such drugs can be commercialized, and quite frankly, the entire notion is ahistorical and not at all consistent with history or scientific discovery.
https://www.reddit.com/r/NWBO/comments/19b20eo/perspective_on_long_drug_development_timelines/
Let me share this story from the NYTimes. I'm going to just give the beginning part and a free access link for people to read it themselves. The main point is literally at the very beginning however. If the view of shorts held, Regeneron would not exist. But it's quite a successful company. So this argument is not a rule. Some people claim there are "rules" which is nonsense. Science, technology development and research follow their own paths and the notion that such absolute rules exist has been proven wrong repeatedly, especially with regard to certain not very bright commentators in this space.
Gift Link: https://www.nytimes.com/2011/11/21/business/eylea-a-vision-drug-wins-long-sought-approval.html?unlocked_article_code=1.PE0.IEZB.aNopTthUtqWA&smid=url-share
Success Long in Coming for Eylea, a Vision Treatment
By Andrew Pollack
Nov. 20, 2011
It has three Nobel Prize winners on its board. Its chairman, P. Roy Vagelos, is a pharmaceutical industry star who ran Merck during its heyday. Its chief scientist has written frequently cited biomedical papers.
Yet for all that, Regeneron Pharmaceuticals has known mostly failure in nearly 24 years of existence, piling up cumulative losses of $1.2 billion.
But that is now changing. Late Friday, the company won approval from the Food and Drug Administration for what is expected to be its first big drug — to treat the wet form of age-related macular degeneration, a leading cause of severe vision loss in the elderly.
For a year after approval, short's kept the share price FLAT for REGN. But Eylea was a blockbuster drug.
So shorts and manipulators can really hang on. But the reality is, they are frequently WRONG. They don't want you to know that, so they bring a lot of effort to fighting success no matter what. They work extremely hard to discourage longs and undermine confidence in companies and their management, no matter who they are, and no matter how competent they are... doesn't matter. Their job is to change the narrative and discourage interest. But the reality is, they often just flat out lie. Complexity is their friend, and the story for many of these companies and new technologies is filled with complexity. They presume that investors like a simple story. So they relentlessly give a narrow, simple story of failure and work to keep the price low to affirm that they are right.
The reality is, we all hope to see a squeeze here. Imagine if we saw a squeeze like GME's.
Wouldn't that be something!
See Dumb Money - you'll enjoy it!
Short Trailer:
biosectinvestor
Member Level
Re: exwannabe post# 665524
Friday, January 19, 2024 4:32:03 PM
Post#
665563
of 665601
ATL-DC is DCVax-L. NWBO had different iterations of dendritic cell vaccines using different antigens. Then they agreed to collaborate on L. NWBO had the technology and know how to begin the process of more robust, globalized trials and address ultimate commercialization.
You can keep trying to suggest false narratives but the evidence is deep and conclusive on the facts that ATL-DC is just a generic way to reference what is also DCVax-L, when NWBO is not participating and the brand name was not used. It’s simply stating what it is. And the title and description in the JAMA phase 3 article is the most obvious confirmation, but there are so many more confirmations, explicit, as well as circumstantial.
Association of Autologous Tumor Lysate-Loaded Dendritic Cell [(ATL-DC)] Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma
A Phase 3 Prospective Externally Controlled Cohort Trial
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
“Question Is treatment with autologous tumor lysate-loaded dendritic cell vaccination (DCVax-L) associated with improved overall survival (OS) for patients with newly diagnosed glioblastoma (nGBM) and recurrent glioblastoma (rGBM) compared with standard of care (SOC)?
Findings In this phase 3 nonrandomized controlled trial of 331 patients, patients with nGBM receiving DCVax-L had a median OS of 19.3 months from randomization (22.4 months from surgery), while contemporaneous, matched external control patients treated with SOC had a median OS of 16.5 months from randomization; for patients with rGBM, median OS was 13.2 months from relapse in the DCVax-L group vs 7.8 months in the external control cohort. Meaningful increases in the long-term tails of the survival curves in both nGBM and rGBM were also observed.
Meaning In this study, adding DCVax-L to SOC was associated with a clinically meaningful and statistically significant improvement in median OS for patients with both nGBM and rGBM compared with matched, contemporaneous external controls.”
Timothy F. Coughesy is the Principal Investigator of the combination trial.
What does he say here?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168782886
Who is listed as Principal Investigator?
Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma
https://clinicaltrials.gov/study/NCT04201873
Timothy F. Coughesy
What did he say? ATL-DC is DCVax-L.
But shorts will constantly straight up lie despite seeing not just this but piles and piles of similar confirmations that they are the same.
Why do they lie? Because it would undermine their entire case, if the world understood the truth and they could not create ambiguity and doubt… they’d have nothing to do or say, and the opportunity to manipulate would vanish. But this is what they do. What you do.
More, also not exhaustive, but very conclusive:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172127616
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
dstock07734
Re: KIPK post# 665446
Friday, January 19, 2024 3:16:28 PM
Post#
665558
of 665599
KIPK,
Great post.
Take a look how Merck and BMY interacted with Timothy Cloughesy on the combo trial. In the end, Merck won the game. Don't forget there was another trial ongoing while Merck was trying to take the combo trial away from BMY.
https://nwbio.com/nw-bio-announces-phase-ii-clinical-trial-program-combining-dcvax-l-and-pembrolizumab-keytruda-for-colorectal-cancer/
While NWBO, BMY, and UCLA struck a collaboration trial, there was also a five-year research project that BMY was involved. The first three years it was under Rober Prins and after Merck scuttled the trial by BMY. In the last two years, Dr. Liau was responsible for the research project.
Project 1: Active immunotherapy combined with checkpoint modulation for glioblastoma (PRINS, ROBERT M)
https://reporter.nih.gov/search/aT6j1fwCh0GppBwEcoWByA/project-details/9357417
https://reporter.nih.gov/search/aT6j1fwCh0GppBwEcoWByA/project-details/9543452
https://reporter.nih.gov/search/aT6j1fwCh0GppBwEcoWByA/project-details/9752974
Project 1: Active immunotherapy combined with checkpoint modulation for glioblastoma (LIAU, LINDA M)
https://reporter.nih.gov/search/3lvpysy0bkeM05TQ0Q0Y5Q/project-details/9983047
https://reporter.nih.gov/search/3lvpysy0bkeM05TQ0Q0Y5Q/project-details/10225550
Can we ponder whether BMY's $74b acquisition of Celgene had anything to do with its losing any potential deal with DCVax-L? The timing is so interesting. That's why I question the possibility.
Bristol-Myers to buy Celgene for $74 billion in largest biopharma deal
https://www.reuters.com/article/idUSKCN1OX0VM/
dstock07734
Re: KIPK post# 665446
Friday, January 19, 2024 3:34:29 PM
Post#
665559
of 665599
Again, after Merck got the combo trial, Merck started a collaboration trial on ADC with Daiichi. Note that before 2019, Merck already had a long term collaboration with Seagen on ADC. Its keytruda combined with Seagen's ADC produced extraordinary results and got FDA approval last year five months ahead PUDFA through Project Orbis. My understanding is that Merck's collaboration deal with Daiichi serves the only purpose of covering its true motive.
https://catalystcr.com/esmo-highlights-adcs/
At ESMO 2023, the brightest star was data from an 886 patient trial (EV-302)3 in first line untreated, locally advanced or unresectable bladder cancer. In this trial, enfortumab vedotin (Padcev®), a Nectin-4-targeted ADC from Seagen and Astellas Pharma was combined with pembrolizumab versus traditional chemotherapy. The data was striking, nearly doubling progression-free survival (PFS) from 6.3 months to 12.5, and nearly doubling overall survival (OS) from 16.1 months to 31.5. Though there were enhanced safety risks with the combination, the presentation received a rare standing ovation, and the results were lauded as “practice changing” for first-line bladder cancer patients.
KIPK
Re: None
Friday, January 19, 2024 9:31:51 AM
Post#
665446
of 665597
What is missing IMO with all this comparative valuations trying to put a price tag on NWBO is the fact that nothing with such deeps of effectiveness (and combination potential), unimaginable safety, and broad potential applications, from all solid cancers to infections, has ever been ever developed and validated to a great extend!!
Add to that the years of dedicated imputes and advancement from highly powerful academia as well as NWBO that has finally managed to craft a platform technology based on empowering the totality of the immune system that was declared by many a waste of time & by the more intelligent that feared its birth, let’s kill this thing!!
Past experience with other M & A that the current NWBO valuation is based on is meaningless IMO, unless the scope of their potential applications & the expected (hoped for) outcome is analyzed & critically considered.
The KITE, JUNO examples that are given at about $13B acquisition range were based on hope/potential only & the CAR-T stuff as a whole for solid tumors ended up being too expensive, having major side effects, ineffective and basically been discarded!!
If we expand this line of thinking, it’s easy to see all potential high flying technologies with billions & billions of $s & years of investments developed/hyped in recent decades have either disappeared or have minimal effectiveness. Stuff like gene editing (BLUE. SGMO), CRISPERs, ZIOP approach, telomerase hype (GERN) & even bunch of antibody-drug conjugate companies have failed miserably.
IMO, there is nothing like NWBO technology out there and thus, its evaluations stands alone and how high that would be is the big question.
NWBO technology has become de-risked, its broad application potentials have been documented & future expansions are reasonably predictable,
I wonder where is will end up & how much a self-aware big name pharma would be willing to pay for it??
Bullish
Sinking Fund
Jun 10, 2002,12:00am EDT
This article is more than 10 years old.
Have financiers torpedoed struggling small companies they were supposedly helping? Lawsuits raise some ugly accusations.
Rodney Young thought he'd hit the big time. For months he had been casting about for cash to save his young telecom-services outfit, Eagletech Communications . Then in March 2000 he sent a team of executives to New York to meet a group of potential investors at Salomon Smith Barney . Young had a patent, but no sales, and yet here were five Salomon officers and a group of investors offering to buy convertible preferred shares from Eagletech for up to $6 million. "I thought these people wanted to help us," he says.
He was soon disabused of that notion. Immediately after the meeting at Salomon, Eagletech's share price began to sink. By November it was down from $14 to 75 cents, erasing $113 million in stock market value. That seemed extreme even for a company that had only $300,000 in cash and was burning $100,000 a month.
Young now claims the wave of selling was led by the very investors at Salomon's table. In a suit filed in Florida, where Eagletech is based, Young alleges that mighty Salomon, along with a group of conspirators, set him up for a fall with convertible-debenture financing, then shorted the common stock all the way down. Salomon has asked the court to throw out the complaint, claiming it did nothing to harm Eagletech.
Eagletech's suit is one of five similar actions. They are led by John O'Quinn , a rapacious plaintiff attorney in Houston who has conjured multimillion-dollar verdicts in breast implants and tobacco. Much of the legal legwork is being done by another Houston lawyer, James W. Christian . Each complaint has been filed on behalf of puny companies against well-heeled financiers who allegedly offered desperately needed capital and then profited by short-selling of shares--all in the thinly regulated world of Bulletin Board stocks. One plaintiff, a legal-research outfit known as Internet Law Library, says it has identified more than 100 companies damaged in convertible-securities schemes, resulting in billions of dollars in lost market value.
The kind of financing at issue, since discredited, goes by the telling name of "death spiral preferred." It worked like traditional convertible securities, except that the conversion price was a movable goalpost. The more the stock went down, the more shares the owner of the convert could claim on converting.
In malevolent hands, this kind of convert could produce a windfall for the owner of the preferred and disaster for the company that issued it. Suppose a company's common stock is trading at $10 and you provide $5 million in convertible financing. In a conventional convert deal, the preferred would be exchangeable for, say, 400,000 shares. In the death spiral variety, the holder of the convertible is entitled to $5 million worth of shares, whatever their price. So you might buy the convertible preferred and immediately short 500,000 shares of common stock. If the stock sinks, you could short more. You might run the stock down to $1, pocketing, say, $20 million on the short sale of 10 million shares. Now you convert your preferred shares, demanding the 10 million common shares you're entitled to and using them to cover short sales. You have shelled out $5 million and collected $20 million.
Whether anything this blatant happened is a matter of dispute. What's certain: Plenty of companies with death spiral financing saw their common shares go into death spirals. Somebody was selling all the way down, and those sellers may have been in cahoots with convert holders.
In O'Quinn's cases the alleged conspirators range from top-tier investment banks like Salomon to mysterious Caribbean-based straw entities. The suits single out two active players in convertible deals: Mark Valentine , former chairman of Canadian brokerage Thomson Kernaghan; and Steven Hicks , president of Southridge Capital. Proving that they either shorted stocks or worked with others who did won't be easy.
The defendants say the allegations are completely unsubstantiated and have asked the courts to dismiss the cases. Michael Rosenblum, an attorney defending those suits, says even if the allegations are true, it doesn't constitute stock manipulation. Thomson Kernaghan is suing one of the plaintiffs, Nanopierce, for defamation in Canada.
According to the suits, Hicks arranged convertible financing for desperate companies, then the investors directly or indirectly shorted the borrowers' stock through Valentine's brokerage, covering their trail by running sales through U.S. and offshore brokers and marketmakers.
The outside investors may not even exist. Internet Law Library claims in its suit that the "investor" buying its convertibles--Cootes Drive LLC, named after a street where it is based in Grand Cayman--was a shell. The entity's correspondence is sent care of Citco Trustees , which is part of Citco, a private financial services company that claims to have $88 billion in assets. Citco hasn't been sued.
The victims were smallish companies traded on the Nasdaq Bulletin Board. Christian and his clients claim the Canadian bankers and others exploited lax oversight of this market by the National Association of Securities Dealers, selling stock they didn't have--"naked" short-selling. Stockbrokers can sometimes get away with it, if the buyers of shorted shares don't demand to see the certificates.
It's on this very point that one alleged victim has decided to fight back. Gary Valinoti , chairman of JagNotes.com , a tiny media company, needed cash to build a TV station for his online stock-news service. So he agreed to take down $10 million in convertible preferred financing. It seemed to be a better deal than selling common at $3 a share.
As soon as JagNotes booked the investment, the share price began to fall. Much to Valinoti's puzzlement, the stock continued falling, in good times and bad. He was further baffled by the list of large shareholders, required to disclose their holdings each month, which showed no selloffs. And yet by February 2001, the stock was trading at 10 cents. "Everybody I knew was buying, but who the hell was selling?" Valinoti wondered.
He concluded it had to be naked short-sellers. Instead of suing his tormentors, Valinoti decided to call their bluff. In February 2002 he announced a recapitalization plan, reconstituting JagNotes common stock into new Class A and B shares. To receive new issues, shareholders had to hand in their old stock certificates.
The recap took effect Apr. 8. As brokerages began sending in certificates on behalf of their clients, gaps appeared. Citibank's beneficial holder list, for example, accounted for 6,300 shares; one investor claimed he owns 1.2 million shares through his Citibank account.
Brokerages that didn't bother to demand certificates when clients bought JagNotes shares are in a jam. Morgan Stanley has a deficit of 500,000 shares, reports JagNotes. UBS Paine Webber seems to be missing 252,000 shares. Eventually brokers must collect from whoever sold them the phantom shares. Meantime they may have to buy on the open market to cover their clients' positions. That should drive up the shares of JagNotes and generate a windfall for Valinoti, who owns 5 million shares. Recent price: 39 cents.
Expect a fierce fight. O'Quinn has already spent about $3 million on discovery. He'll keep spending because, he says, "This could be bigger than tobacco."
"This (fight) could be bigger than tobacco" - FORBES article 2002
— kristen shaughnessy (@kshaughnessy2) January 19, 2024
The fight to expose the counterfeit shares flooding our financial markets started decades ago. That's how big this fight is. You'll find a familiar "voice" in this Forbes article from 2002.
When you call out…
Member Level
Re: flipper44 post# 665381
Friday, January 19, 2024 8:01:27 AM
Post#
665401
of 665457
I just want to make one more point on the Elios tlpo versus tlpodc phase ii disease free melanoma trial and show you how they are working like Novocure does. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10401209/
Look at the link/figure below. Now realize that based upon this, they’re saying, well since tlpo and tlpodc are essentially equal, we should do a phase iii on tlpo because we can’t really afford to keep trialing tlpodc.
But wait a minute, look at cases at risk at thirty and 36 months.🤨 By 36 months, which is what they go by in their trial “survival section,” only one, that’s right, one data point was used to get their survival number for tlpo.😬 But look, they matured the tlpodc group and let 19 cases be at risk for the 36 month analysis.
You see what they did there? They didn’t bother to build a DC manufacturing base like NWBO, so apparently they said fck it, let’s just get one good 36 month data point and call it a day, so that we don’t have to build up an industry. (They also only had six tlpo data points at 30 months)
(Note: remember the Elios trial was for melanoma)
https://www.ncbi.nlm.nih.gov/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Click%20on%20image%20to%20zoom&p=PMC3&id=10401209_jitc-2023-006665f02.jpg
In the American public securities industry, is paid for disinfomation free to roam unrestrained by regulators ?
i.e., Poor Man said, “Even if my team doesn’t drive this to zero, we’ve already made a fortune! My team has already received their bonuses for their work on this stock.”
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173657172
In the American public securities industry, is paid for disinfomation free to roam unrestrained by regulators ?
Poor Man said, “Even if my team doesn’t drive this to zero, we’ve already made a fortune!” (Figure 4).[59] Another relevant tidbit was where Poor Man stated, “My team has already received their bonuses for their work on this stock.”
https://twitter.com/alphavestcap/status/1748342868064768449
@alphavestcap
$nwbo
https://www.reddit.com/r/NWBO/comments/1603vv0/the_american_system_profits_over_life_nwbos/
https://twitter.com/TommyBaxendale/status/1655583081258942466
https://twitter.com/hoffmann6383/status/1747712460361027956
The American System - Profits Over Life; A Tiny Biotech's Battle to Bring a Cancer Vaccine to Market
DDOC
By: Hoffmann6383
There is a small and obscure biotechnology company attempting to bring a personalized vaccine to long suffering Glioblastoma (“GBM”) patients. GBM is the most aggressive and deadly form of brain cancer. This company, Northwest Biotherapeutics, Inc (“NWBO”), completed a phase III trial using a personalized autologous tumor lysate-loaded dendritic cell vaccine, called DCVax-L, that showed a clinically meaningful and statistically significant improvement in survival of GBM patients[1] and are now attempting to bring this treatment to market. On the other side, market makers and hedge funds (the “Wolf Pack”) are doing everything in their power to keep this vaccine from getting to the market in an effort to protect their own pocketbook.
NWBO started their DCVax-L Phase III trial in 2006 (the “Trial”).[2] The Trial took about 2 decades to complete.[3] It cost hundreds of millions of dollars.[4] The complexity of the blood-brain barrier in addition to the cost and time required to conduct a Phase 3 study has made progress in the treatment of GBM a rare occurrence. Newly diagnosed glioblastoma (“nGBM”) patients haven’t seen an improvement in standard of care (SOC) since 2005.[5] Recurrent glioblastoma (“rGBM”) patients have no SOC.[6] A diagnosis of GBM is near certain death.[7]
There are 14,490 Americans that are expected to receive a GBM diagnosis in 2023 and more than 10,000 that will die.[8] None of this mattered to the Wolf Pack. The Wolf Pack made a bet against NWBO and they are doing their best to protect that bet, i.e. naked, unreported and/or underreported short positions. To this end, the Wolf Pack has extensively and illegally manipulated NWBO’s share price and they have engaged in an enormous distortion campaign on social media despite real life consequences to NWBO, NWBO shareholders and most importantly, cancer patients. In this article, I’ll (1) introduce you to NWBO, (2) walk you through the lawsuit alleging illegal share price manipulation, (3) give a first-hand perspective of the social media distortion campaign and finally, (4) give some closing thoughts.
(1) Who is Northwest Biotherapeutics, Inc.?
Northwest Biotherapeutics, Inc. is a clinical stage biotechnology company focused on the development of personalized cancer vaccines to treat a broad range of solid tumor cancers.[9] NWBO’s lead treatment is DCVax-L, and the company has completed a Phase III nonrandomized controlled trial of 331 patients with GBM, a deadly brain cancer.[10] Five-year survival for nGBM is less than 5%.[11] The SOC for nGBM consists of surgical resection of the tumor, radiation therapy, and concomitant and adjuvant chemotherapy with temozolomide.[12] Nearly 100% of the tumors recur. There is no SOC for rGBM.[13] Since 2005 there have been hundreds of clinical trials in nGBM and rGBM. Prior to the results being shown for the DCVax-L trial, survival benefit has only been shown in one phase 3 trial in nGBM and no phase 3 trials in rGBM have shown a survival benefit.[14] That is until NWBO’s autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) demonstrated a survival benefit in nGBM and rGBM patients.[15]
A JAMA Oncology paper published on November 17, 2022 showed that adding DCVax-L to SOC showed a clinically meaningful and statistically significant improvement in mOS with both nGBM and rGBM when compared with matched, contemporaneous external controls.[16] On March 20, 2023 NWBO announced they received one of the first Medicines and Healthcare products Regulatory Agency (“MHRA”) licenses in the UK for commercial manufacturing of cell therapy products that allows for global delivery of their cell therapy products.[17] In an interview published July 14, 2023, Les Goldman, Senior Vice President of NWBO, stated that the company will be applying for approval in 4 places with the MHRA in the United Kingdom being the first.[18] On August 9th NWBO filed their 10-Q for the second quarter of 2023 and stated that the company is in “active discussions in regard to certain combination treatment regimens, and is planning for certain strategic trials with such combination treatments.”[19] On December 21st, 2023, NWBO filed their Marketing Authorization Application ("MAA") with the UK's MHRA for nGBM and rGBM. [20] Upon submitting their MAA, Linda Powers, CEO of NWBO, stated,
We are very excited to reach this important milestone as the culmination of more than 20 years of research and clinical development. We are extremely grateful to all of the parties who have made this possible, including the patients, the investigators and the shareholders whose patience and support have been invaluable. We believe DCVax-L can offer a much needed new treatment option for GBM patients, both alone and in combination with other treatment agents. We look forward to bringing the treatment to as many patients as possible, including in community settings where most patients are treated. [20]
DCVax-L is currently being used in two ongoing combination trials. One UCLA trial involves DCVax-L combined with poly-ICLC.[21] This is for nGBM and rGBM and unpublished data is showing approximately 50% overall survival at 100 months.[22] Another trial involves DCVax-L, poly-ICLC and Keytruda.[23] This trial is for rGBM and unpublished data is showing approximately 60-65% survival at 800 days (Figure 1).[24]
r/wallstreetbets - The American System - Profits Over Life; A Tiny Biotech's Battle to Bring a Cancer Vaccine to Market
Figure 1 - Keytruda/Poly-ICLC/DCVax-L Combination Trial in rGBM
On June 3, 2023 NWBO presented at the Industry Expert Theater at ASCO. You can see this presentation and much more information on NWBO here: https://nwbio.com/
(2) Illegal Share Price Manipulation – The Spoofing Lawsuit
Spoofing is a form of disruptive algorithmic trading activity to manipulate the markets.[25] Spoofers place bids or offers on stocks with the intent to cancel before the orders are filled.[26] Spoofing may cause prices to change because the market interprets the one-sided pressure in the limit order book as a shift in the balance of the number of investors who wish to purchase or sell the asset, which causes prices to increase (more buyers than sellers) or prices to decline (more sellers than buyers).[27]
On April 10, 2023, NWBO filed an Amended Complaint in the U.S. District Court for the Southern District of New York alleging that market makers Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Susquehanna International Group LLP, Virtu Americas LLC (collectively “Defendants”) deliberately engaged in repeated manipulative spoofing of NWBO’s stock from December 5, 2017 – August 1, 2022 (Figure 2).[28] NWBO states that Defendants engaged in 2,849 spoofing incidents occurring on 395 of 1,171 trading days, or nearly 34% of the trading days, in the relevant period.[29] NWBO sold over 283 million shares at manipulated prices, 49 million of which were sold at the closing price on dates where spoofing episodes occurred.[30] NWBO claims that the market manipulation directly impacted the price of NWBO’s shares sold into the market, causing NWBO significant losses as the stock was sold at artificially depressed prices.[31]
r/wallstreetbets - The American System - Profits Over Life; A Tiny Biotech's Battle to Bring a Cancer Vaccine to Market
Figure 2 - NWBO Spoofing Lawsuit Caption
May 10th, 2022 was the single most egregious day of illegal share price manipulation on record according to the Complaint.[32] There were a total of 100 spoofing episodes between Defendants totaling 2,883,387 shares of fictitious baiting orders (Figure 3).[33] On that day the market learned NWBO met both its primary and secondary endpoints with statistical significance, displayed an excellent safety profile and showed meaningful increases in long-term tails of the survival curves for both nGBM and rGBM.[34] Despite the excellent trial results, the share price declined from $1.73 to $0.3862, a 52 week low.[35] This was a 78% decline of the share price on a day with nothing but positive news related to NWBO.[36]
r/wallstreetbets - The American System - Profits Over Life; A Tiny Biotech's Battle to Bring a Cancer Vaccine to Market
Figure 3 - May 10, 2022 Spoofing Episodes
A large portion of the spoofing incidents on May 10, 2022 occurred prior to the DCVax-L data being presented publicly, for the first time, at 11:10 EST.[37] For example, 13 of 29 spoofing incidents by Citadel Securities, LLC (“Citadel”) occurred prior to the data being presented publicly.[38] Citadel executed 24 of their 29 spoofing incidents on May 10th prior to the presentation being completed. Essentially, Citadel wanted the market to think the trial results were a failure before the market even digested said results. It wasn’t just Citadel that wanted to portray the DCVax-L trial as a failure. It was all of the Defendants. We also had the head of a hedge fund live tweeting that the trial had failed.[39] There was a reporter claiming the trial had failed.[40] This reporter, Adam Feuerstein, is cited in Defendants’ Joint Memorandum of Law in Support of Motion to Dismiss Amended Complaint for the proposition that NWBO suffered a crisis.[41] The Defendants claim it was a “crisis” when the positive DCVax-L Phase III data was presented.[42] When Citizens for Responsibility and Ethics in Washington executive director, Melanie Sloan, asked the SEC to investigate NWBO’s stock for market manipulation she paid particular attention to Adam Feuerstein, whose relentless blog posts have not only been filled with exaggeration, mischaracterization and half-truths, but curiously have also coincided with spikes in short trading.[43]
The Defendants described their actions as “bedrock market-making activity” and if they are unable to continue with this activity it could potentially upend “the entire U.S. equity market system”.[44] Essentially, spoofing is part of Defendants’ business model and if anyone tells them to stop, they are going to bring down the entire market.
On the other hand, NWBO claims in their Court filings that the vast amount of illegal spoofing incidents is being done to cover naked short positions:
And like here, the plaintiff alleged that defendants sought to benefit from their spoofing by obtaining shares at below-market prices in order to cover short positions established through a related alleged scheme of naked short selling. [45]
Despite Defendants’ claims, spoofing is illegal, period. Spoofing is not a “bedrock market-making activity”. This is an activity that lands you in jail.[46]
Spoofing, much like naked shorting, is an illegal tactic used to destroy companies and cause their shareholders to lose a significant amount of their investments.[47] Oftentimes spoofing and naked shorting go hand in hand.
One doesn’t illegally manipulate NWBO’s stock price thousands of times in a vacuum. There is likely a significant naked, unreported and/or underreported short position that is being protected by the Wolf Pack.
(3) Firsthand View of an Extensive Social Media Distortion Campaign
What’s one way to protect a significant naked, unreported or underreported short position in a company whose stock is largely held by retail? An unrelenting misinformation campaign. Enter an online stock message board like InvestorsHub (“IHub”) with thousands of different investment forums. IHub has approximately 8,800 message boards for US listed companies, 12,984 boards for the US OTC, 2,131 for Canadian companies and 917 message boards for other markets.[48] In total IHub has approximately 24,832 message boards.[49] Out of these nearly 25k message boards, NWBO is and has been for over a year, the #1 most read and posted on forum at IHub.[50] This isn’t just a one off. NWBO wasn’t the most posted on and viewed board for a single day, but nearly every single day, for years on end. On an average day, you can look at the NWBO IHub board and see the same regurgitated negative narratives often containing false and/or misleading information. These negative narratives are an attempt to drown out any positive discussion.
What does a typical IHub poster on NWBO’s message board look like? Let’s take a look at Exwannabe (“Ex”).[51] Ex started posting on NWBO’s message board in 2014 and is up to 12,183 posts as of writing this article. He posts on weekends, weekdays, and at all hours of the day. Ex has, on multiple occasions, pointed out that he owns no shares of the company. Ex’s posts are always negative, often misleading and sometimes downright false. Ex claims he has been on these boards for nearly nine years and 12,000+ posts because (1) he found the company interesting, (2) he finds the NWBO supporters disgusting, (3) he wants to set the record straight and (4) he loves watching a good train wreck.[52] Could this lone poster just be a white knight that decided to dedicate a large portion of his life to helping the poor retail that invested in NWBO without any financial incentive to himself or herself? Sure, it’s possible, but unlikely, given the very negative comments he has made about NWBO longs. Now, throw in another 20+ Exwannabes that post on the same NWBO forum using the same reasoning for posting. Are the poor NWBO retail investors the luckiest retail investor base on the planet with so many white knights at their disposal or is something else happening here? Enter Poor Man and his team of supposed white knights.
Who is Poor Man? Poor Man is an IHub alias born on October 30, 2015.[53] Poor Man, as of writing this article, has 7,546 posts on NWBO’s message board and 205 posts on USRM’s board.[54] USRM is the stock symbol for U.S. Stem Cell, Inc. This is important for later. Much like Ex, Poor Man has an overwhelmingly negative slant to his NWBO posts on IHub. In August of 2022 I engaged in a private conversation with Poor Man on IHub.[55] It was a colorful conversation.[56] At one point Poor Man wrote to me stating, “If you want to work for short sellers, let me know.”[57] Poor Man went on to state “I helped bring the stock price down and got them delisted. So I’ve already received my bonus. Everything else is just small change at 68 cents. 7 years ago this stock was $10…”.[58] Poor Man also said, “Even if my team doesn’t drive this to zero, we’ve already made a fortune!” (Figure 4).[59] Another relevant tidbit was where Poor Man stated, “My team has already received their bonuses for their work on this stock.”[60]
r/wallstreetbets - The American System - Profits Over Life; A Tiny Biotech's Battle to Bring a Cancer Vaccine to Market
Figure 4 - Poor Man Private IHub Message
Poor Man stated that he works with a team on behalf of short sellers to drive the NWBO share price to zero. Perhaps Poor Man has simply been messing with me, a favorite ending statement of his reads, “And remember, everyone is lying.” Initially, I didn’t think much of the Poor Man conversation. That is until I became aware of a case filed on January 28, 2016 in the 17th Judicial Circuit, Broward County, FL, Case No. CACE-16-001616.[61] Remember where I said we would be circling back to USRM, or U.S. Stem Cell, Inc.? They are the plaintiff in the case. The defendants were aliases on IHub and Yahoo message boards including the same Poor Man currently still posting at IHub.[62] The Plaintiff believed Poor Man might have been working in concert with multiple people to publish disparaging and defamatory statements about USRM on the IHub message boards with the purpose of bringing economic loss to USRM (Figure 5).[63] It's important to note the case was dismissed on procedural grounds. The Court didn’t have personal jurisdiction over Poor Man under Florida’s Long Arm Statute. Therefore, the case was never heard on its merits.
r/wallstreetbets - The American System - Profits Over Life; A Tiny Biotech's Battle to Bring a Cancer Vaccine to Market
Figure 5 - Poor Man Complaint Allegations
Poor Man apparently has a history of trying to destroy largely retail held stocks through disparaging and defamatory statements on social media. Despite this history, which IHub was made aware of when they were served with a subpoena in this lawsuit, they recently made Poor Man a moderator of its’ NWBO message board.[64]
What happens, as in my case, when you don’t fall in line and join the misinformation campaign? Let’s take a look at my interactions with Legend431 at IHub, or murcidencel11 at X, or catmeadowlands at X, or crashoverIHub at X – all the same person. Apparently, they stick the goons on you to try to intimidate you into silence. I have received phone calls which I eventually realized (after letting the entire message save to my VM) were from prankdial.com. I have received numerous threatening messages in private messages on both IHub and twitter, with some of them shown in Figure 6. The personally identifying information has been redacted in Figure 6 and my notations are in red. My home address has been posted publicly on IHub at least twice. My cell phone number has been posted on both IHub and X. My wife’s name has been posted on IHub. There have been requests to meet at a bar next to my house so we can “hash things out”. A sampling of some of the messages can be seen below.
r/wallstreetbets - The American System - Profits Over Life; A Tiny Biotech's Battle to Bring a Cancer Vaccine to Market
Figure 6 - Legend431 Public and Private IHub Messages
There is a reason NWBO is the number one most active message board on IHub and it isn’t because all the traffic is organic. This is a smear campaign on steroids.
(4) Final Word
The Wolf Pack appear to have made a large bet that NWBO would fail, consequences to GBM patients be damned. There was a time where it looked like they might be right. NWBO had to pause their trial for roughly two years as they ran short on funds. Despite the hurdles, NWBO has now wrapped up their trial and have submitted their first application for regulatory approval in the UK. The overwhelming daily negative social media narratives are an attempt to drown out NWBO’s good news.
I don’t know for certain whether this overwhelming negative social media presence is there to protect any naked, unreported or underreported short position. Maybe this is all organic discussion. Doubtful, but I don’t care. NWBO isn’t a meme stock. This isn’t a fledging movie theater chain that is losing audiences to streaming apps. This isn’t a brick-and-mortar gaming store when everything is moving to online purchases. NWBO retail longs don’t invest in a company for the squeeze despite underlying concerns in said company. NWBO is the opposite. We invest in NWBO for the underlying company. If a squeeze happens, great. That’s karma for betting against a treatment for long suffering cancer patients. If there isn’t a squeeze, great. NWBO will find success either way.
DISCLOSURES: The author of this article holds 100,000+ common shares of NWBO. The author has received no compensation in connection with this article. This is an opinion piece. The information in this article is for informational purposes only. The information contained herein should not be understood or construed as legal, medical or financial advice.
CITATIONS:
[1] https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
[2] https://classic.clinicaltrials.gov/ct2/show/NCT00045968
[3] Id.
[4] www.nwbio.com
[5] https://ascopubs.org/doi/full/10.1200/JOP.2017.025536#:~:text=The%20current%20standard%20of%20care,year%20survival%20compared%20with%20treatment
[6] Id.
[7] Id.
[8] https://braintumor.org/events/glioblastoma-awareness-day/about-glioblastoma/#:~:text=Glioblastoma%20Facts%20%26%20Figures&text=More%20than%2014%2C490%20Americans%20are,succumb%20to%20glioblastoma%20every%20year.
[9] www.nwbio.com
[10] Id.
[11] https://www.nature.com/articles/s41598-020-68011-4
[12] https://www.ncbi.nlm.nih.gov/books/NBK469987/
[13] https://academic.oup.com/neuro-oncology/article/20/8/1034/4922286
[14] https://jamanetwork.com/journals/jama/article-abstract/2666504
[15] https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
[16] Id.
[17] https://nwbio.com/northwest-biotherapeutics-and-advent-bioservices-announce-receipt-of-license-for-commercial-manufacturing-at-sawston-u-k-facility/
[18] https://www.podchaser.com/podcasts/big-biz-radio-show-212005/episodes/big-biz-show-07142023-179502721
[19] https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057823001633/nwbo-20230630x10q.htm
[20] https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/
[21] https://classic.clinicaltrials.gov/ct2/show/NCT01204684?term=iclc&cond=glioblastoma&draw=3&rank=13
[22] https://www.youtube.com/watch?v=Yyihecx6gDo&t=1362s
[23] https://classic.clinicaltrials.gov/ct2/show/NCT04201873
[24] https://drive.google.com/file/d/1qfZuznKHiXaZrHIRACbDhkPhgO8d0ojp/view?usp=sharing
[25] https://en.wikipedia.org/wiki/Spoofing_(finance)
[26] Id.
[27] Id.
[28] https://www.cohenmilstein.com/case-study/northwest-biotherapeutics-inc-securities-litigation
[29] https://www.cohenmilstein.com/sites/default/files/NWBO%20v.%20Canaccord%20Amend.%20Complaint-%2004102023.pdf
[30] Id.
[31] Id.
[32] Id.
[33] Id.
[34] Id.
[35] Id.
[36] Id.
[37] https://www.youtube.com/watch?v=Gshv4VWU9JQ
[38] https://www.cohenmilstein.com/sites/default/files/NWBO%20v.%20Canaccord%20Amd.%20Comp.%20-%20Exbt.%201%20-%2004102923.pdf
[39] Twitter.com/midwesthedgie
[40] https://www.statnews.com/2022/05/10/it-took-years-but-the-failure-and-futility-of-northwest-bios-brain-cancer-vaccine-is-now-in-the-open/
[41] https://www.courtlistener.com/docket/66579590/northwest-biotherapeutics-inc-v-canaccord-genuity-llc/, Document #115
[42] Id.
[43] https://www.washingtonpost.com/business/northwest-biotherapeutics-stock-woes-highlight-the-harm-of-short-sales/2014/09/26/78b99b0a-4507-11e4-b47c-f5889e061e5f_story.html
[44] Id.
[45] https://storage.courtlistener.com/recap/gov.uscourts.nysd.590344/gov.uscourts.nysd.590344.123.0.pdf
[46] https://news.bloomberglaw.com/banking-law/ex-merrill-metals-traders-sentenced-to-one-year-for-spoofing-1
[47] https://westviewnews.org/2023/01/23/our-capital-markets-are-under-siege/james/
[48] https://investorshub.advfn.com/boards/hubstocks.aspx
[49] Id.
[50] https://investorshub.advfn.com/boards/most_post.aspx?p=d
[51] https://investorshub.advfn.com/boards/profile.aspx?user=81442&page=347
[52] https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172442036
[53] https://investorshub.advfn.com/boards/profilea.aspx?user=546046
[54] https://investorshub.advfn.com/boards/profileb.aspx?user=546046
[55] https://drive.google.com/file/d/1ppIw_rV3OOnDJYNV1dRosu8wjcGYBmpy/view?usp=sharing
[56] Id.
[57] Id.
[58] Id.
[59] Id.
[60] Id.
[61] https://drive.google.com/file/d/1BnnP3lqZoG7GS0-SIWjXl7UfXlkL5_my/view?usp=sharing
[62] Id.
[63] Id.
[64] https://drive.google.com/file/d/1t_XDHaYhSM_dxL_iIpLJJZW89FIV8J9s/view?usp=sharing
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henp2p
·
9 hr. ago
I am in this stock due to the fact that a close friend has glioblastoma and it is without a cure.. D-vax can help and extend her life, but it is not in the market yet. It is terrible to watch her pain. She has a very young child too🥲. Terrible!!!
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Mindless-Divide107
·
14 hr. ago
Hey. Lots if interested People do not want a cure. So just drink warm lemon water or die.
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this-user-name-sucks
·
15 hr. ago
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edited 11 hr. ago
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VegetableCreme6487
·
15 hr. ago
Hoffmann is the new and NWBO are the new Roaring Kitty and Gmaetstop
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OwnCalligrapher2488
·
19 hr. ago
only a matter of time
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starrico
·
19 hr. ago
https://youtu.be/cU_-1ECBMAU?si=W1bjne_VyscoGZXv
This is from a year ago. It’s about DCVAX.
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Agile_Seaweed_6470
·
19 hr. ago
I wonder if we pushed this up 5% today on our own
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Agile_Seaweed_6470
·
19 hr. ago
Yes, i had to pay the 5% premium… but I’m not not taking this trade
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Blurghblagh
·
19 hr. ago
Total BS.
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No_Storm_7686
·
20 hr. ago
·
edited 20 hr. ago
All this yapping yet you dont seem to realise that ”cancer” is just a broad label on thousunds of dirrent conditions. Theres no single ”vacine for cancer”.
He also posted this post on the subredit desicated to this stock around 5 months ago. Hes tottaly biased and simply writes a wall of text so people who are to lazy to read or check sources blindly trust him. Hes just pumping his bad performing biotech stock…
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Bigfoot_17
·
17 hr. ago
This isn't a vaccine for cancer.... it's a personalized vaccine for YOUR cancer! Do some real DD. They take YOUR cancer and YOUR dendritic cells and create the vaccine. It's injected multiple times into your arm over the year and YOUR immune system goes after the cancer cells displaying the antigens that were picked up by YOUR dendritic cells. (hundreds of antigens not just a couple like Car-T). It's truly a breakthrough.
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Bigfoot_17
·
20 hr. ago
Got in originally with 18,000shares before data lock at $0.33, after data lock announcement it screamed to $2.51. had to do some real DD after that to see WTF I got myself into! Have 460,000 now added 1000 today to support the cause again! With this stock you're not investing just in NWBO, you're investing in the end to wall street corruption (that's the only real scary part to this investment). Hoff needs a cape for taking on some of these bad actors! 🍻🍻🍻 To you Hoff!
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Accomplished_Ad_4838
·
20 hr. ago
Great post Hoffman thanks.
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VegetableCreme6487
·
20 hr. ago
I’ve done my DD as well, and I believe NWBO and the DCVax platform is legitimate. I’m in!
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TurfTank79
·
22 hr. ago
Website back up https://nwbio.com
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Freefromoutcome
·
22 hr. ago
Just Fomoed in 1,000 at HOD
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Soy_Boy_69420
·
22 hr. ago
whats up with the yahoo conversations section https://finance.yahoo.com/quote/NWBO/community?p=NWBO
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zen2me
·
22 hr. ago
JAMA published with 70 authors.
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Awkward_Operation216
·
22 hr. ago
OtC . Good luck on the vaccine thou
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red_purple_red
·
23 hr. ago
They could sell their research to a bigger company.
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Accomplished-Boat360
·
23 hr. ago
"Smear campaign on steroids"
FACT
If I hadn't actually met people from the company I wouldn't know what to think with all the misinformation being posted.
MURIDENCEL is the real deal. Ignore at your own peril. GLTA
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Spreadthewealth007
·
23 hr. ago
As usual, impressive and great stuff from Hoff. Thanks again for an awesome summary.
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LordBobTheWhale
·
23 hr. ago
Had a few bucks left over in Fidelity and bought 6 shares!
Here's to hodling until it saves lives and moons high enough to buy me a sandwich 🥪😀🥂
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JStiltz22
·
23 hr. ago
Great work
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freudmv
·
1 day ago
Just a thought: with the number of share everyone has y’all should get together and put a person on the board. Then you will be the insider and the rest of us will know if this is truly legit. Two things may be true at once: they may have a treatment that gives the patients a few more months and others may be manipulating the price. Some people are researchers who are dedicated to finding cure and then there’s the people who just want to make money and really don’t care if it is from cancer cures or casket sales. I’ll put $1k VOO and we can see where we are in 10 years.
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addieo81
·
1 day ago
Someone bought the recent top, a man’s got to do what a man’s got to do..
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Neowwwwww
·
1 day ago
Imagine if Wall Street bets breaks open corruption and leads to eliminating cancer. Fuck your jimmy
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Magic_carpetsheik
·
1 day ago
Kind of like how bromate is not allowed in flour in every other country except the United States. -bromate is linked to breast cancer.
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Gang_Gang_Onward
·
1 day ago
this is the classic bullshit reddit stock pick you tried to convince yourself to stop buying, you change your mind and think its finally gonna be the one and then youre left with a fucking turd in your watchlist every day -2%, -3%, down 50%+ from your entry, etc.
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AnywhereRemarkable31
·
1 day ago
im in with 1k shares
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teri-jhalak-srivalli
·
1 day ago
Kenny and his mayo back at it again?
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Overthehill410
·
1 day ago
OP - I haven’t read their studies, but if this treatment was as potentially valuable as I believe the initial three paragraphs are implying then I am assuming the investor base wouldn’t be retail but instead the blue chip funds that generally are the bedrock of biotech. I don’t put it past the larger funds like citadel to do shady quant stuff with all diluted retail based companies, but let’s be real if this thing is as good as the CEO is making it out to be baker, Wellington, perceptive etc would all have significant stakes and manipulation wouldn’t be a problem.
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Capital-Chard-6862
·
1 day ago
NW Bio is trading on the OTC. First off- The OTC is a highly manipulated market. Second, Your comment about why "blue-chip" funds" are not investing is based off not knowing what type of stocks these types of funds invest in. These larger funds are very risk adverse, NW Bio isnt on their radar because as of today, they have not products on the market sell, and as such no earnings or revenues to report outside of the UK "Specials" Program. Upon approval of DCVax the market will correct the SP. Ask yourself this: Why, just 10 short years ago, was Nvidia @ $5 SP, only to increase 10,000% since? Was was there a made rush to own Nvdia shares in such a short period? Where were all these investors back in 2014 when NVDA was trading at $5 per common? The market severely under-estimated NVDAs ability to bring products to market. I remember when Citron was shorting NVDA to death, only to get crushed as Nvidia out-performed. I know because I went threw the dark-times with NVDA, but man oh man did it pay-off just being patient. Some of these shares I hold are up over 10,000%. to date. My point: The Market has it wrong with NW Bio as well, and upon UK MHRA approval, there will be a major revaluation of the Companys SP, to the upside. Wall Street gets it wrong sometimes, but will correct itself. Sometimes in a huge way. I suspect that is what will happen once DCVax receives MHRA marketing approval. In these types of stocks, you are either in early, or chasing to the upside once the stock does make a move because of some binary new event. Me? I'd rather be eraly to the party, than late.
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Overthehill410
·
19 hr. ago
That simply isn’t how biotech works. All of those funds invest in early phase companies, it’s their entire model. I happen to work in biotech so am a little more familiar with it than most, but this isn’t exactly a secret. Just Google biotech financing and you will likely seen over a hundred financings in the last 12 months of companies with promising pipelines. Furthermore, the larger pharma companies would have been on it as a license partner or an MA target. While there are some moderately promising molecules in pipeline, last time I check on glioglastoma the only recent approval was the med device company out of Philly that had a radio wave therapy. If this was really viewed as durable, effective and safe their abstract/poster would have been accepted for ASCO/Esmo and people would be lining up to invest. Once again haven’t read the study results, maybe it’s just inept management but 20 years is a gross amount of time for a clinical trial and then to have a retail base both are red flags.
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ApprehensiveWork2326
·
1 day ago
It's listed on the OTC and very few institutional funds invest there or can even invest there due restrictions on their investment strategy.
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level 3
Overthehill410
·
18 hr. ago
Okay looking slightly more into this, this just seems like an utterly horrible management team. You have an autologous vaccine, ie super heavy manufacturing costs, and you decide to forgo FDA filing and allocate your last 1.5 million to filing in…… the U.K. The increase in life expectancy is obviously better than pure chemo, but is it enough to get favorable reimbursement on a suspect trial design? Also not sure if they were delisted or were always OTC but once again that’s a failure of management along the way. Having 1.1 billion outstanding shares is frankly absurd, and likely chilling their ability to be invested in. I could still squint and see a MA target for some of the players in this space like BMS or Novartis. While they likely got screwed at some point by shady trading, this company would appear to be its own worst enemy. There is no reason an oncology biotech with positive phase 3 should be in their position.
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HisDanishDudeness
·
1 day ago
·
edited 1 day ago
Robert Prins at the UCLA, has been researching for a decade in checkpoint inhibitors efficacy OR why they fail. That work has been published along the way THREE times in Nature.
https://www.nature.com/articles/s41591-018-0337-7
https://www.nature.com/articles/s41467-021-26940-2
https://www.nature.com/articles/s41467-021-24293-4
And his team is now following up with the latest article in Nature, currently in pre-print, that is the current outcome of all of this work ...
The combo trial of DCVax-L with poly-iclc, having run for 14 years.
https://pubmed.ncbi.nlm.nih.gov/37790490/
Take DCVax-L's efficacy and then multiply with 3 to 4.
Yes ... THATS what is about to unfold.
We have NEVER witnessed efficacy numbers against the worst of ALL cancers, like this before. And DCVax-L works with ALL solid tumors.
And NWBO already have automation and scaling ready. One week to make all doses. Pfizer and Moderna and their 2030 mRNA vaccines currently takes more than a month. DCVax-L counters > 11.000 neoantigens. mRNA between 6-34.
Big pharmas with a checkpoint inhibitor left out of the equation, will be hit.
Read the details here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173627729
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level 2
VegetableCreme6487
·
1 hr. ago
I hear a roaring kitty
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WeEatBabies
·
1 day ago
!remindme 1 year
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level 1
LongliveTCGs
·
1 day ago
This is like a C grade porn production, you’ve got the set up, the actors but cause the conclusion was no where in sight, I’ve failed to ejaculate
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TinkTheHustler
Cake day
·
1 day ago
HOFF.....thank you for the post.
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machyume
·
1 day ago
You had me at Citadel is a defendant. I’ll throw in $1k for it. I’m also a brain tumor survivor, not GBM thank goodness, but I know how rough it feels.
For anyone going through GBM, the new mRNA vax in EU also looks promising. If this company is smart it should dual phase in other countries in order to grow in a more favorable climate. Biotech in the US is brutal.
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level 2
VegetableCreme6487
·
1 hr. ago
Meow
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IndependentNo6285
·
1 day ago
Citadel eh, rings a bell. Grubby
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level 1
GoodGuyOver50
·
1 day ago
Say what? This is beyond messed up.
"Poor Man apparently has a history of trying to destroy largely retail held stocks through disparaging and defamatory statements on social media. Despite this history, which IHub was made aware of when they were served with a subpoena in this lawsuit, they recently made Poor Man a moderator of its’ NWBO message board.[64]"
Comment image
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Iceman72021
·
1 day ago
Investing $1010 tonight
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SargentPoohBear
·
1 day ago
MLA formatted r/karmacourt post
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Rg_dk
·
1 day ago
Great!
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SS324
·
1 day ago
If it's that promising, big pharma and wall street wouldn't short it, they would buy it. I think the reality is that nobody knows if this drug is going to work.
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level 2
Capital-Chard-6862
·
1 day ago
The vaccine/drug as already completed a PH3 Study with over 350+ patients.....best trial results for GBM in over 23 years. Dont take MY word for it though. Please have a look a the JAMA peer-review of the PH3 data, released last year with over 70 Authors. The vaccine works, there is no speculation at this point.
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SS324
·
20 hr. ago
When did this data come out? Im looking at this which suggests otherwise https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10296384/
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level 1
Pin_ups
·
1 day ago
I see a lot of those stocks daily on Merrill Edge apps, most of them just quick cash grab and then goes to zero with 12mo or so. I have seen enough biotech stocks never see the light beyond their R&D.
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Crazy-Entertainer242
·
1 day ago
I have seen enough biotech stocks never see the light beyond their R&D.
You've peaked my interest. Can you give me a couple examples, please? It might not be interesting or time well spent looking up these biotech stocks, to some folks, but I'm just weird and drawn to stuff like this. Thanks!
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level 3
Pin_ups
·
1 day ago
Merrill edge stock daily screener should give some insight.
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level 4
Crazy-Entertainer242
·
1 day ago
Sounds good. Thanks!
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level 1
TogicalLom
·
1 day ago
“Ignorance is bliss”
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level 1
Croiyx
·
1 day ago
🅱️🅰️🐐
I’ve been holding this shit since 2018 and after not reading your extensive DD you’ve convinced me to buy 1,000 more shares :8882:
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shot-by-ford
·
1 day ago
DYOR before investing in penny stocks, that’s all I’ll say
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arabidopsis
·
1 day ago
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level 1
jtenn22
·
1 day ago
Here’s my issue with them. After reading through the studies— it appears they changed the methodology in their p3 study with primary endpoints and comparisons (internal to external)… and the FDA I think had an issue with this. I personally have an issue with potential massaging of data to achieve certain endpoint results. I am in no way suggesting they did this I’m just providing my opinion on the matter. Clearly, beyond what is mentioned with the alleged stock manipulation , the market also is clearly not viewing this company as a good prospect.
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Capital-Chard-6862
·
1 day ago
The FDA didnt have a issue with it, they themselves made all patients cross-over and receive the vaccine. Dr. Linda Liau from UCLA Oncology confirmed this last spring.
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this-user-name-sucks
·
15 hr. ago
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level 3
jtenn22
·
1 day ago
Have they updated this?
“The primary study endpoint is OS (overall survival) compared to external controls in newly diagnosed glioblastoma, and the first secondary endpoint is OS compared to external controls in recurrent glioblastoma”
Focus on external controls… that’s just not how this works.
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OldenBoy
Cake day
·
21 hr. ago
times change: "FDA: Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products"
https://www.fda.gov/media/164960/download
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Capital-Chard-6862
·
1 day ago
sure it is. The FDA is accepting historical controls for deadly diseases vs. placebo. Reason being is that with deadly outcomes such as GBM, having patients in placebo is inhumane. The FDA released a paper on this whole topic last January. You also cannot "rig" OS. Using external controls for indications such as GBM are completely acceptable because the outcomes are known....you die in a certain amount of time based on data from 100s of trials. It what they call median survival rate.
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jtenn22
·
1 day ago
The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in newly diagnosed glioblastoma
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jtenn22
·
1 day ago
The phase 3 results, as far as I can tell— were not clear based on their Methodology for end points-/ and that is why they are trading for 50 cents.. it’s not market manipulation. The phase 3 study should be redone and done properly this time.
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jtenn22
·
17 hr. ago
No I don’t think they would lie. However I can’t understand this: why hasn’t a larger pharma company bought them out? Why haven’t they submitted for fda marketing approval?
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Capital-Chard-6862
·
1 day ago
So overall survival, which is golden standard for GBM, was not convincing to you? Because that was the end-point. Are you insinuating that the 70+ Authors are lying in making their determination and conclusion on DCVax in the JAMA peer-review?
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level 5
tompopcorn89
·
22 hr. ago
70+ Doctors
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Bigfoot_17
·
1 day ago
You're 4 years behind on this argument, the SAP (statistical analysis plan) was changed and approved by ALL RA's involved in the trial prior to unbinding of the data, can't massage what you can't see. OS (overall survival) is the gold standard, can't fake people living 5+ years after receiving DCVAX-L. Additionally with immunotherapy they discovered the tumor would swell due to the attacks from the immune system making it look like the tumor was growing when in fact it was getting killed off. That's why PFS (Progression Free Survival) was dropped as an endpoint. Again this argument about changed endpoints after unblinding was screamed and yelled by the FUDsters to try and protect their short positions and ultimately squashed by lead scientists such as Dr. Linda Liau in the trial. Cheers.
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jtenn22
·
15 hr. ago
Why haven’t they submitted a nda ?
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Bigfoot_17
·
15 hr. ago
They just submitted MAA to MHRA, UK on Dec 21, 2023. Where their global production facility is and where they've had compassionate use since 2015. That's step 1. Step 2, Once approved by MHRA the new IRP (International Recognition Procedure) through the MHRA will give quick approvals by FDA, Canada, EU, Australia, Japan, Singapore next. That's why.
https://www.gov.uk/government/news/mhras-new-international-recognition-procedure-irp-goes-live-from-1-january-2024
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level 5
jtenn22
·
14 hr. ago
Hope I’m wrong. Good luck.
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level 6
Bigfoot_17
·
14 hr. ago
Don't need luck, it's all backed by science 🤓
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starjets
·
1 day ago
·
edited 1 day ago
Hoff, you are the type of person needed for this situation. Your relentless work to inform the truth and thereby protect the science makes you a Legend in our community. I firmly believe that the MAA will be granted soon along with some great BP partnerships. Shorts will not see this coming freight train and will drown before reaching the escapes.
My sense is that NWBO’s sp is near a flashpoint that will make history only weeks from now and we ( Longs ) ain’t missing that one !
DCVax creates a TCell storm at a 600x factor and hunts cancer cells in their very hidden entrenchmen . Not one company holds this secret formula , only Northwest Biotherapeutics !
Just like for Polio, the world will soon line up for cancer prevention shots : That is my prediction for the future of this company .
All we need to do is wait and stay cool : the hard work has been completed : over 20 years of research, 1,7 million pages presented to the MHRA, $hundreds of millions burned and over 1000 glioblastoma compationate treatments .
I need this, you all need this, the world needs this science : cancer cures & prevention can’t wait !
https://nwbio.com
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Designer_Brief_4949
·
1 day ago
unpublished data
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Capital-Chard-6862
·
1 day ago
JAMA peer-reviewed. 70+ authors. It ceases to amaze me how many investors lack the DD to make such comments with seeking facts, but here we are: https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
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Designer_Brief_4949
·
23 hr. ago
Median survival of the treated group was 19 months versus 16 months in the control group.
Other measures showed improvements in survival of 3-6 months.
That's a academic improvement, not a commercially viable product.
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Smackdaddy122
·
1 day ago
aight I'm in. fuck citadel
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malhione
·
1 day ago
Great post r/wallstreetbets 👍🏽
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PDXbeerdo
·
1 day ago
Recent positive articles in two of the most prolific medical research journals (Nature and JAMA), human tissue license issued and manufacturing facility already inspected (Sawston), patents galore, and science via Linda Liau, Chair of the Department of Neurosurgery at the David Geffen School of Medicine at UCLA. Yup
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MAGA_feels
·
1 day ago
Be careful out there my man. Sounds like you have attracted the attention of a dangerous crowd. But God bless you for blowing the rape whistle on them. You’ve got giant balls and I respect it.
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NomzStorM
·
1 day ago
Comment image
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RagingBearBull
·
1 day ago
🎈🎈
If they have better lobsiest then their competitors this could work.
If they don't ..... It's not making it to the market.
Oncology is one of those old dogs that won't go down with a fight, and this product could destroy their bottom line
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level 2
hoffmann6383
OP
·
1 day ago
The UK process is nothing like the US. I don't share those concerns with the UK approval process. Next is Health Canada. I also don't share those concerns with Health Canada. After that massive pressure will be put on the FDA to approve.
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RagingBearBull
·
1 day ago
🎈🎈
I didn't read the post because it had more than 4 words. But I would imagine those countries that you listed.
Especially the UK and Canada have a lobiest problem as well.
However I just don't see it happening in our regaltory environment unless these vaccine companies can provide a boat load of money to the regulatory body and legislators.
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jbirdo15
·
1 day ago
What platforms are ppl buying on?
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level 1
hanzelmanchen
·
1 day ago
Oh man this is a scam company - just look at their materials and compare them to blue chip biotechs
-4
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whicky1978
·
2 days ago
all about the pentiums BBBY
You had me “There is a small obscure biotech company”
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InorganicRelics
·
1 day ago
It wasn’t the wife bit?
If you saw those pics, you’d be buying calls
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bosox0408
·
2 days ago
Hell yeah I’m in
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level 1
generic_commenter999
·
2 days ago
Lmao so fucking regarded
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HeyNow846
·
2 days ago
I'm going to look at it just based on your effort, Jesus how long did that take to put together.
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this-user-name-sucks
·
15 hr. ago
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level 1
ChurchillCigar
·
2 days ago
Everytime I see something along the lines of "shorts are killing this company", I know the post is written by a baggy who believes in tinfoil conspiracies akin to the BBBY big brain investors
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lUNITl
·
2 days ago
The study failed. It has confounding variables that invalidate the results even if they’re positive. All of this is in their annual reports and is why the stock is trading for nothing.
Isn’t this below the market cap threshold for WSB anyway?
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Capital-Chard-6862
·
1 day ago
Failed? So you are insinuating that 70+ peer-review Author's are wrong? Are you a brain surgeon in order to make this determination? Trial was a complete success. But dont believe me: https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
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lUNITl
·
1 day ago
I don’t think they’re wrong, I think it’s a research paper that is trying to learn something from a very long and expensive study which is a good thing.
I also think that you can read for yourself in NWBO’s annual report that the study is unlikely to lead to FDA approval due to the fact that both endpoints were confounded by Pseudo progression and the crossover protocol.
The study is worthless for FDA approval. You cannot get a drug to market that failed to meet any endpoints of its study.
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OldenBoy
Cake day
·
11 hr. ago
Again, "confounded" does not mean failed. It means the data was muddied and is no longer applicable, so they changed the endpoints to compare against external controls (per FDA guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products ). Worth noting these original endpoints were muddied because of new science that was learned during the trial (pseudo-progression).
These endpoints, AKA the trial endpoints, passed. Bonus, zero side effects. The risk-reward for a terminal illness like brain cancer that regulators look for is there.
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OldenBoy
Cake day
·
1 day ago
the market cap is nearly $1B, and the trial succeeded per the JAMA article linked in the post. JAMA is one of the most respected scientific journals (and of course peer reviewed)—what say you to that?
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lUNITl
·
22 hr. ago
Under the Protocol the primary endpoint was progression free survival, or PFS, and the secondary endpoint was overall survival, or OS. Both of these endpoints were confounded: the PFS endpoint by pseudo-progression, and the OS endpoint by the “crossover” provision in the trial design
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057823000185/nwbo-20221231x10k.htm
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OldenBoy
Cake day
·
22 hr. ago
yeah no crap, but the endpoints were changed BEFORE data lock to reflect Overall Survival, which is more important than PFS which is a proxy for OS. And those endpoints were confounded because patients who received placebo, if their tumor came back, were given the option to take the drug—which almost all did. This option was mandated by the FDA for ethical reasons. Do you think the FDA will punish them for following their own recommendation?
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lUNITl
·
20 hr. ago
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level 3
lUNITl
·
1 day ago
I say if you think that’s what the article is saying you don’t understand what “confounding variables” means.
To be clear, I don’t care if you want to lose money on this penny stock. I’ve just been following this company and cel sci for enough years to know that everyone running them is full of shit but very convincing. The actual obvious bear cases are very hard to come by at this point because the only people following the stocks still are in the cult.
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antimodez
·
19 hr. ago
Bless your heart for trying to teach people on Reddit that study design actually matters.
Skipping to the results section is just so much easier.
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tompopcorn89
·
22 hr. ago
Why would Merck be running a combo trial with Keytruda if it was all bullshit?
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this-user-name-sucks
·
15 hr. ago
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level 5
lUNITl
·
20 hr. ago
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Capital-Chard-6862
·
1 day ago
So are the 70+ Authors on the peer-review "full of shit" as well? https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
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lUNITl
·
1 day ago
No, they aren’t the FDA approving marketing of the drug. They’re scientists doing research.
Read the annual report, the admission that both endpoints are confounded is in there and I guarantee it’s conveniently left out of OP’s wall of text. You can’t get FDA approval for a drug that failed to meet a single one of its stated endpoints. Your stock is garbage, it’s not a cabal of short sellers conspiring against you, it just failed.
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Onyourknees__
·
2 days ago
May the short fux catch the diseases of advancements and cures they suppress.
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Trade-Runner
·
2 days ago
What the actual fuck?
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raannathr333
·
2 days ago
This is either a home run, or dead money. I like it.
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gimegime21
·
22 hr. ago
A home run therapy for a rare form of cancer does not equal a home run investment just fyi
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OldenBoy
Cake day
·
11 hr. ago
DCVax is likely tumor agnostic. No reason to think it only treats brain cancer (which isn't that rare)--they just thought if they proved it worked for the toughest cancer, it'd be promising for others too. They're already treating many other cancer types in the UK through compassionate use.
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lUNITl
·
22 hr. ago
Under the Protocol the primary endpoint was progression free survival, or PFS, and the secondary endpoint was overall survival, or OS. Both of these endpoints were confounded: the PFS endpoint by pseudo-progression, and the OS endpoint by the “crossover” provision in the trial design
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057823000185/nwbo-20221231x10k.htm
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OldenBoy
Cake day
·
11 hr. ago
I'm not sure you know what confounded means. It does not mean failed. It means no longer applicable. Hence, the new endpoints--which passed with statistical significance.
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datajackal
·
2 days ago
I will put 10 dollars and wait 10 years
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Jigglypuff_Smashes
·
2 days ago
People out here in the comments calling this a “cure” company. No one was cured by this treatment. Survival time of the median patient increased by a couple months. And their plan is to submit in the UK? NICE is not nice; they pay for survival benefit and there isnt that much here. Sucks a wolf pack went after them but it’s very difficult to keep an expensive, labor intensive treatment on the market.
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Capital-Chard-6862
·
1 day ago
While DCVax isnt a cure, you are right, some patients have lived past 5 years. Also, the combo results with Poly, which as in Ph2, are extraordinary. Most surviving beyond 5 years. DCVax will be approved in the UK, I think we are beyond that point of debate. As far as labor intensive, Flaskworks will dramatically change all this with a 100% automated system. This will drive the price down of making the vaccine significantly. We are about 6-8 months from this being up and running.
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Jigglypuff_Smashes
·
1 day ago
Of course it will be approved but what level will it be reimbursed at? That’s the tricky part in Europe (for all you US readers). Not a hater, just want people to focus on the relevant factors for investing in a business (revenue vs cost). Could work out but it’s not a slam dunk.
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BigBega69
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2 days ago
Really interesting thanks for sharing
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Agile_Seaweed_6470
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2 days ago
Order set. I’ll take the ride
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OutMotoring
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2 days ago
Citadel and Virtua again… the usual suspects. I am in!
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WACS_On
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2 days ago
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catecholaminergic
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2 days ago
Yeah I'm buying some shares.
Edit nwbo's been doing poorly since 2002. They're not a startup and a low share price isn't recent.
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Slut_Spoiler
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2 days ago
Has zero girlfriends
People have been crushing cancer cure companies for decades, but I'm rooting for you
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KingWalnut888
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2 days ago
What’s ihub
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Croiyx
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1 day ago
🅱️🅰️🐐
Less appealing stocktwits
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thunder12123
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2 days ago
Dendreon pt 2
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normal-re-editor
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2 days ago
I'm not going to read all this. I'm either happy for you or sorry this happened to you.
Reload and come back on Monday.
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Narfu187
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2 days ago
Someone send this to Biden to he can fulfill his campaign promise to cure cancer.
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Minnesotamad12
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2 days ago
You didn’t have to write all this. Like most on this sub, a couple dumb vulgar jokes and the name of the stock would have gotten me to invest.
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Whaty0urname
·
20 hr. ago
Listen, I work in pharma, I look quite frequently at the docs and charts similar to what OP put and I can't agree with you more.
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SouthPhilly_215
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1 day ago
I’m in!
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Alarmed-Apple-9437
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1 day ago
Comment image
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United_Candle9363
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2 days ago
I don’t think he cares if you invest. It’s a story that needs to be told. Not our problem that you can’t read more than a paragraph
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Designer_Brief_4949
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1 day ago
It’s all based on “unpublished data”
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United_Candle9363
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1 day ago
Besides being published in JAMA, it’s soon to be published in prestigious Nature. You can’t hide the proof, or the science
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Designer_Brief_4949
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23 hr. ago
JAMA shows a 3-6 month improvement in survival.
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raannathr333
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1 day ago
I believe study results were published in JAMA… https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
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Minnesotamad12
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2 days ago
Whatever nerd. I didn’t even read what you said either
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IWouldntIn1981
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1 day ago
You are operating on another level.
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Mano_lu_Cont
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1 day ago
Well played
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Successful-Soup4129
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2 days ago
perhaps focus this effort and energy on building a website for the company.
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Interesting-Tennis82
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1 day ago
They apparently forgot to pay a fee. It should be back up and running soon.
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United_Candle9363
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1 day ago
NWBO has quite the website , if you think there was a lot of effort and energy in this post, you should see the website nwbio.com
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1reallyhatemondays
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2 days ago
Chatgpt please show a tldr, thanks chatgpt.
TL;DR: Northwest Biotherapeutics, Inc. (NWBO), a biotech company, developed a promising cancer vaccine for Glioblastoma. Market manipulators, referred to as the "Wolf Pack," allegedly engaged in illegal share price manipulation, including spoofing, to hinder NWBO's success. The article details a social media distortion campaign aimed at spreading misinformation. Despite challenges, NWBO has submitted regulatory applications, and the author, a NWBO shareholder, emphasizes the potential benefits for cancer patients. The piece concludes with disclosures and citations.
https://twitter.com/hoffmann6383/status/1747712460361027956
biosectinvestor
Member Level
Re: abeta post# 665153
Thursday, January 18, 2024 6:23:57 PM
Post#
665305
of 665354
There have been numerous dendritic vaccine efforts that failed, which is the key reason the shorts have been so successful here. People tried with Dendritic ace vaccines before and failed.
Additionally, one would probably do well to investigate further the difference in their version. Seems they have different language suggesting it is not the “same” even with the term “Lysate”. They say “Tumor Lysate, Particle Only (TLPO) vaccine”. The particle only concept should be explored a bit more. There have been other wannabes that have disappeared over time, but of course there will be efforts also for alternatives if NWBO pairs up with a single Big Pharma, just like there are numerous Car-T and Checkpoint Inhibitor trials and drugs with different companies.
Not really a reason for anyone to freak out given NWBO has orphan status, a successfully completed Phase 3, and other significant accomplishments under its belt including technology to automate production.
It is also an important reason for them to keep automation technology closely held rather than giving everyone that asks for it, their own machine.
As for patents, patents are not for “dendritic cells”, you can’t patent a natural human cell. You patent the processes that allow you to derive your drug using that cell. NWBO has numerous patents and continues to evolve its process with Flaskworks, and patents for new processes have been issued and are in process. Plus they are farther ahead on other research like combinations.
I would not worry about competitors. Many will try, and they are still far behind, relatively speaking. There will be room for competitors, if any survive.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
abeta
Re: Bill B post# 665149
Thursday, January 18, 2024 10:47:58 AM
Post#
665153
of 665353
Bill
https://www.orbishealthsolutions.com/immuno-oncology
I would say they are equal to or ahead of Direct.
Pipeline
https://www.eliostherapeutics.com/pipeline
Through our subsidiary, Elios Therapeutics, Orbis is developing the Tumor Lysate, Particle Only (TLPO) vaccine, an autologous (or personalized) therapeutic cancer vaccine designed to stimulate the immune system to recognize tumor cells and fight a patient’s specific cancer.
The vaccine is concurrently initiating a basket trial in patients with solid tumors and moving into a Phase 3 registrational trial for advanced stage melanoma patients based on a positive Phase IIb study showing the vaccine was safe and effective.
https://www.orbishealthsolutions.com/immuno-oncology
Kristen Shaughnessy
“The 5 of Us” Podcast, TEDx Speaker, Women in Tech Global Conference Speaker, Former NYC Anchor/Reporter, Irish America Magazine's Top 50 Irish American Power Women, Irish America's Top Media 30, Emmy Nominee“The 5 of Us” Podcast, TEDx Speaker, Women in Tech Global Conference Speaker, Former NYC Anchor/Reporter, Irish America Magazine's Top 50 Irish American Power Women, Irish America's Top Media 30, Emmy Nominee
Read how shorts tried to destroy a company treating brain cancer. The company is now suing seven market makers.
Northwest Bio's stock price plunged while and after the company announced a successful clinical trial to treat the most common and aggressive form of brain cancer, glioblastoma.
From CohenMilstein PR.
"Based on the detailed data presented in the complaint, one of the most egregious examples of this behavior occurred on May 10, 2022, at the very moment the topline breakthrough results of the Phase 3 clinical trial of DCVax-L to treat glioblastoma, the most common and aggressive form of brain cancer, were being announced at the prestigious New York Academy of Sciences medical conference. Despite the presentation of significant positive data, the company alleges that during and after the announcement the defendants engaged in extensive spates of spoofing, forcing the company’s stock price down. In a market free from manipulation, the market response should have been strongly positive, not dramatically negative, in response to the positive news. Instead, the result was a $1.6 billion loss in market cap, with the share price dropping from the $2.05 high on May 9 to a low of 36.4 cents on May 10, 2022—a staggering decline of 82%."
This is a detailed thread written by an attorney.
https://lnkd.in/d9rUejs9
https://lnkd.in/dHqX6bSu
It amazes me how the high and mighty get to brainwash so-called regulators, lawmakers and the People. The criminals get away with not only condoning outright crime, the purported conveyance of ownership that is not owned, the cascacading of, and perpetual default in settling, their debt for the securities they purportedly “sold” but in truth counterfeited. Yet, when their self inflicted blackmail comes home to roost and they are hampered in their counterfeiting acts, or heaven forbid, have to deliver what they’ve “sold” - taken proceeds for; they cry like babies and accuse investors of a “short squeeze”. Here’s the truth of what a “short squeeze” is: It is the 100% self inflicted consequence of financial terrorists having cornered themselves into ceasing their doubling-down accumulating liabilities and, sometimes, purchasing what they’ve already purported to have “sold”, but didn’t own the ownership they’ve counterfeited. The corrupt regulators aid and abet their default and witch-hunt anyone who stands for holding the counterfeiters accountable to settle their debts; instead of doing their jobs to protect the true investors and enforce settlement. It is time for Congress to see through the lies and disband the crime cartel.
…see more
Re: ae kusterer post# 663155
Thursday, January 11, 2024 11:57:31 AM
Post#
663254
of 665277
Thanks Ae Kusterer. Highlighting some excerpts:
https://smithonstocks.com/highly-probable-uk-approval-of-dcvax-l-in-1h-2024-would-be-a-crowning-achievement-for-northwest-biotherapeutics/
Excerpts:
UK Approval Would Transform Northwest Biotherapeutics into A Premier Commercial Stage Biotech
MHRA published on its website that it had accepted the SAP.
- This means that the MHRA review will be based on evaluating the primary endpoint of mOS in ndGBM and the secondary endpoint of mOS in rGBM...
- Phase 3 results as reported in a peer reviewed article in JAMA Oncology showed that these endpoints were reached with extremely impressive p values. The p-value for mOS in ndGBM was <0.002 and the p-value in rGBM was <0.001.
Under the accelerated pathway, the MHRA commits to reviewing the application in 150 business days or less. This indicates a decision on approval at the latest could come by mid-July, 2024. I think it could be meaningfully sooner.
- My conclusion about accelerated approval for DCVax-L is supported by the agency’s actions with the rapid approval of Pfizer’s COVID vaccine Comirnaty. Initial data was submitted to MHRA on October 1, 2020 and conditional approval was granted on December 2, 2020. Pfizer only issued one press release on the review process and this was on December 2, 2020, the day on which Comirnaty was approved.
- Moreover, there is an urgent need for improved therapy in GBM as no new drug has been shown to meaningfully extend survival in ndGBM since temozolomide in 2005 and for rGBM since the mid-1990s with the Gliadel wafer.
- The EMA and FDA both have great respect for the MHRA…would likely expedite their regulatory reviews.
- Canada has a very close working relationship with the UK which could lead to approval not long after the UK.
Bullish
BULLISH