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You said Sawston is not owned by NWBO so you are wrong ...
All points to this getting manufacturing approval. That's all that matters now. The endless Advent, Toucan and Sawston conspiracies are exhausting on ihub
Wrong with that statement....
https://www.heraldtribune.com/story/business/2021/12/30/joan-lappin-biotech-firm-nwbo-gets-uk-approval-special-treatment/9025652002/
"This could ultimately lead to an automated assembly line process as the system is refined. Note that both the Sawston plant and the Flaskworks technologies are directly owned by NWBO."
For whatever reason?
Tuesday has been the favorite day to release news for Northwest
"Interesting" view on Big Pharma
Peter Kostis chimed in on Twitter about NWBO to Jim Kramer. Trial getting a little attention. We need more of this.
Hey! @jimcramer Check out NWBO . They already have a vaccine for GBM brain cancer. About to release phase III TLD of a 13 yr. trial. Plus it works with all solid tumors. Do your DD and you'll see that sometimes the little guy can win.
— Peter Kostis (@peterjkostis) February 26, 2021
What would a stock buyback do?
"A company can also buy its shares on the open market at the market price. It is often the case, however, that the announcement of a buyback causes the share price to shoot up because the market perceives it as a positive signal."
Anyone else think LP has this on her list to help bury the shorts??
I do!!????
https://www.investopedia.com/articles/02/041702.asp
Go ahead and short it then ;)
Rkmatters are you still around? I believe you predicted November for unblinding to occur back in January? You're posts were always informative....Any thoughts?
Quality of life for Alex Trebek from chemo is taking its toll. He's very candid in a recent interview. I think he'd accept DCVAX direct if given the opportunity to.
https://www.usatoday.com/story/entertainment/celebrities/2019/10/07/alex-trebek-jeopardy-host-pancreatic-cancer-diagnosis/3896011002/
Christmas in July?? LOL
Wishful thinking but at this point why not!!
Thanks for the the laugh!!
I think FDA approval is going to happen this year. Now the patients are "speaking" louder than ever before :)....IMHO
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610509.htm?utm_campaign=06122018_Statement_FDA Commissioner statement on incorporating the patient voice&utm_medium=email&utm_source=Eloqua
"We heard the message that modernized approval endpoints in oncology were necessary because many of the older approaches to clinical trial recruitment and design dated back to an era of combination cytotoxic chemotherapies, when patients were exposed to significant treatment toxicities. These therapies sometimes offered only modest advances in efficacy, and they came with serious side effects. So the endpoints we assessed in trials were designed to offset the significant risks these drugs posed. New and more targeted therapies, however, operate differently. There are more opportunities to demonstrate significantly higher rates of benefit in carefully selected patients—and often show reduced toxicity—in smaller cohorts of patients who might express a marker that predicts clinical response. In these cases, surrogate endpoints—or measures of intermediate clinical benefit—can be both clinically relevant and highly valued by patients. These measures might include objective response rate or progression-free survival for solid tumors, or cytogenic response rate and minimal residual disease for hematological cancers."
http://dailybruin.com/2016/07/10/ucla-researchers-develop-new-immunotherapy-for-advanced-brain-cancer/
UCLA researchers have developed a new combination immunotherapy to treat advanced brain cancer.
The combination treatment works by preventing brain cancer cells from shielding themselves from a patient’s own immune responses.
The three-year study, published Thursday, found that antibody blocking of an immune cell’s PD-1 surface receptors combined with a dendritic cell vaccine is more effective than using either one alone. Previous studies have shown these surface receptors to suppress normal immune response while dendritic cell vaccinations induce normal immune response, through intracranial immune cell activation.
Robert M. Prins, leader of the cancer research and member of the UCLA Jonsson Comprehensive Cancer Center, said he and his team discovered that effective immunity to glioblastoma requires a robust killer T cell response in order to attenuate immune cells within the tumor.
Although PD-1 antibody blockade removes the shield that glioblastomas activate to hide from a patient’s immune system, it may not be successful by itself in tumors that do not have sufficient infiltration of killer T cells, a type of white blood cell that lyses cancer cells. The dendritic cell vaccination allows necessary infiltration of these killer T cells into the tumors. Thus, the two combined treatment of both vaccine and antibody blockade allow for a more effective immunotherapy.
Glioblastoma constitutes about 15.4 percent of all primary brain tumors, according to the American Brain Tumor Association. Most people who are diagnosed face a median survival rate of 14.6 months.
The research findings are the first to outline how an effective immune response can be activated in the advanced brain cancer, said Prins.
Prins and Linda Liau, another leader of the research team, have filed to obtain a patent on the glioblastoma vaccine combination treatment.
Abeta, Flipper, Senti or???
http://www.cell.com/cancer-cell/fulltext/S1535-6108(17)30253-2
Longitudinal transcriptome analysis showed that expression subtype is retained in 55% of cases.
I believe Mesenchymal represents 45% of the 3 subtypes.....
AND what % does DCVax-L help from the MESENCHYMAL group?? ??
https://www.mdanderson.org/publications/cancer-frontline/2017/08/findings-may-help-doctors-customize-glioblastoma-treatment.html?cmpid=frontline_brain_glioblastoma
The team, led by Erik Sulman, M.D., Ph.D., associate professor of Radiation Oncology, identified gene expression patterns that differed from surrounding immune cells, demonstrating the effects of chemotherapy and radiation treatments. They further defined tumor-intrinsic transcriptional subtypes designated as proneural, neural, mesenchymal and classical.
Sulman and his team were able to identify common mutations in genes such as TP53, EGFR, IDH1 and PTEN as well as the frequent and concurrent presence of abnormalities in the p53, RB and receptor kinase pathways. Additional analysis revealed four clusters – proneural, mesenchymal, neural and classical – all highly associated with genomic abnormalities.
“Glioblastoma tumor cells, along with the tumor microenvironment, together create a complex milieu that ultimately promotes tumor cell transcriptomic adaptability and disease progression,” says Sulman. “Our study explored the properties of the microenvironment in different glioblastoma expression subtypes before and after therapeutic intervention. In doing so, we improved the robustness of gene expression subtype classification through revised gene signatures and analytical methodology."
The team’s results indicate that the tumor microenvironment affects expression-based classification of glioblastoma, both at the primary disease stage and at disease recurrence, implicating a role for macrophages and microglia in treatment response.
Longitudinal transcriptome analysis showed that expression subtype is retained in 55 percent of cases,” says Sulman. “Gene signature-based tumor microenvironment inference revealed a decrease in invading monocytes and subtype-dependent increase in macrophages/microglia cells upon disease recurrence.”
Glioblastoma expression subtypes have been related to genomic abnormalities treatment response and differences in tumor microenvironment. Sulman’s team defined tumor-intrinsic gene expression subtypes, which establish a role for the tumor immune environment in shaping the tumor cell transcriptome.
The finding could have implications for new approaches to more personalized therapy as currently all glioblastoma patients are treated similarly. The study could lay the ground work to enhance understanding of how to more effectively stratifying patients, a crucial step for precision medicine and more targeted, effective therapies.
Is MESENCHYMAL the key to DCVax-L's success?
Draw your own conclusion, I've made mine.
They have to be close to an ending of this trial... I hope it fares well with everyone involved. GLTA
Very interesting!
Adam Feuersteins new job...Senior writer at Statnews. Lets hope this is a "turning of the tide" for Northwest??
Form 10-K April 17, 2017
https://seekingalpha.com/filing/3506097
Manufacturing of DCVax
We use a batch manufacturing technology for our DCVax products, and we believe this manufacturing approach is a key part of the practicality of our product and its economic feasibility. Generally, we are able to produce enough doses for the patient’s treatment regimen through just one manufacturing process. When a batch of DCVax product has been made, we then cryopreserve it.
Both of these technologies, the personalized batch manufacturing for each patient and the cryopreservation, are essential elements of our manufacturing model and product economics. Together, they enable us to usually incur the high costs of manufacturing just one time for each patient, and then store the multi-year or multi-dose quantity of product, frozen, in single doses.
This makes DCVax effectively an “off the shelf” product for the patient after the initial manufacturing, even though it is personalized, and we anticipate that this will enable the pricing of DCVax to be in line with other new cancer drugs. We also believe that both economies of scale and automation will further enhance the product economics. The manufacturing process today is also rapid: about 8 days for DCVax-L, and 7 days for DCVax-Direct, followed by quality control and release testing.
We contract out the manufacturing of our DCVax products to Cognate BioServices. Although there are many contract manufacturers for small molecule drugs and for biologics, there are very few companies who specialize in manufacturing living cell products. Manufacturing of cellular products is fundamentally different than production of small molecules or biologics, and the regulatory requirements are very difficult to meet. Cognate BioServices has long specialized in the production of cellular products, and has a leading track record with such products.
Our DCVax programs require a large amount of capacity in these specialized manufacturing facilities, and generally require that the large capacity be dedicated exclusively to our programs. Most medical products, including other types of cellular products, are made in batches on a pre-scheduled basis. In contrast, our products are fully personalized and can only be made in individual personalized batches, not large-scale batches of standardized products, and our products are made on demand, on an ongoing basis. So, the manufacturing suites generally must be dedicated entirely to NW Bio’s products.
Cognate BioServices’ manufacturing facility for clinical-grade cell products is located in Memphis, Tennessee. Cognate BioServices' facility is approximately 80,000 square feet and contains substantial buildout expansion space in addition to the portions currently built out and in use. The current manufacturing facilities are sufficient to produce DCVax for at least several thousand patients per year. The expansion space will allow us to procure significantly increasing capacity when needed for commercial readiness. We are also developing a facility for manufacturing in the U.K. for the European market. It is necessary for us to have manufacturing operations in Europe to meet the logistical requirements for European patients relating to the collection, delivery and processing of the patient’s blood draw containing the immune cells (for which the time window is too limited to reach the US manufacturing facility).
I drank the cool aid and it's really good. LOL!!
Sorry....but there's way too many ducks lined up in a row here for me to walk away now. Waiting for grand finale. GLTA
You're funny!
Centralized Automatic manufacturing on a large scale basis has not started. When and IF it does guess what happens? Just take a wild guess ex ;)
Production efficiency:
This was talked about for months a long time ago... remember longs??
"The high cost of production for first generation dendritic cell therapies is often used as evidence that DCVax therapies will not be economically viable.
These arguments consistently ignore the fact that Northwest Biotherapeutics has developed and regularly utilizes methods to freeze dendritic cells for transport and storage.
This gives NWBO an enormous production cost advantage over these older therapies and over current would-be competitors, in part because it allows centralized processing of the patient samples at one enormous facility.
Further, as mentioned, Northwest has developed and patented automated mfg processes that further reduce cost. The manufacturing processes are similar for all of Northwest’s therapies.
For each, the production process is identical regardless of the patient, and even regardless of the solid tumor cancer type. Combined with centralized automatic mfg, this greatly simplifies large scale production, potentially allowing cost efficiency to reach levels unexpected for a product that is not a pill."
While we wait......
“Just the fact that we have some phase 3 trials in glioblastoma, where for years we had a hard time getting past phase II trials, is an encouraging sign,” said Michael Lim, MD, director of the brain tumor immunotherapy program at Johns Hopkins Kimmel Comprehensive Cancer Center, in a blog post on the National Cancer Institute’s website. “For the first time in a long time, there’s some real excitement [in the field].”
http://blog.braintumor.org/potential-glioblastoma-treatments-entering-the-pivotal-phase-of-evaluation/
If they take the drug away and the positive results go away then that is seen as positive confirmation. I believe they would resume treatment and verify again. Time will tell
Thank you for a great post!
Sent To: http://www.alz.org/contact_us_contact_us.asp
Good results should produce a 1B market cap next week....Total speculation on my part of course. That's a $28pps! The sky's the limit if one let's imagination get away here! I'm going to hit 18 holes of golf now and dream of playing pebble beach in the fall LOL!
A 10B market cap would be low!!!
With 35.71M shares outstanding 10B is $280pps.....and IMO AVXL will be valued up from there unless great news soon with an early buyout offer of 5-10B! I'm certainly not opposed to that! We'll know a lot more by the end of July-Aug. Stayed tuned with patience. May even have another good swing trade coming to take some profits? ;)
That would be nice LOL!
With 35.71M shares outstanding pps would be $560/ share. Dreaming of that day ??
Breast Cancer Vaccines Moving Forward at a Fast Clip
I'm behind this company 100%. We'll see what ASCO and June news brings us.
http://www.ascopost.com/issues/april-10-2016/breast-cancer-vaccines-moving-forward-at-a-fast-clip/
Great post! Liked it so much had to put it on yahoo board!!
Hope you don't mind :)
New Alzheimer's drug result 'spectacular' on Counterpoint
Found on stocktwits/ yahoo message board
https://radio.abc.net.au/programitem/pgwdVYkWeG?play=true
Breast Cancer Vaccines Moving Forward at a Fast Clip
http://www.ascopost.com/issues/april-10-2016/breast-cancer-vaccines-moving-forward-at-a-fast-clip/?platform=hootsuite
Vaccines for both secondary and primary prevention of breast cancer are showing potential in clinical trials, according to Elizabeth A. Mittendorf, MD, PhD, who is leading much of the vaccine research at the University of Texas MD Anderson Cancer Center, Houston. Vaccine platforms being explored include dendritic cell vaccines, whole tumor cell vaccines (allogeneic, autologous), recombinant protein vaccines, peptide vaccines, DNA vaccines, and recombinant viral vectors. The focus of Dr. Mittendorf’s research has been peptide vaccines, which she described at the 2016 Miami Breast Cancer Conference.1
Peptides are derived from immunogenic proteins. They can be combined with an immunoadjuvant and given as a simple injection, which stimulates peptide-specific immune responses. “They are simple to construct, very easy to manufacture, inexpensive, and would be ‘off-the-shelf’ therapy that’s easily exportable to the community,” revealed Dr. Mittendorf, Associate Professor in the Department of Breast Surgical Oncology at MD Anderson.
Current peptide vaccines have profited from lessons learned 2 decades ago in metastatic disease, where they were not effective, presumably because of diffuse disease. “It’s unlikely that a simple approach like a peptide vaccine that stimulates a T-cell response against a single antigen would be effective in the metastatic setting,” she explained. “We now have ideas about how to use vaccines in combinations with other therapies to address this limitation.”
Management Team looks VERY strong.
http://investors.galenabiopharma.com/investors/corporate-governance/management-team/person-details/default.aspx?ItemId=c6cf43e3-84b3-49da-ae40-f34e5ee40a6e
"Dr. Nejadnik joins Galena from Jazz Pharmaceuticals where he was the Executive Director, Hematology-Oncology and led the clinical team towards a recently filed NDA. Prior to Jazz, he spent seven years at Johnson & Johnson working on numerous compounds in early and late stage registrational trials in immunology and oncology."
Immuno-Oncology 101.
A great newsletter to add to your emails.
http://immuno-oncologynews.com/immuno-oncology/
Amen to that! Waiting for news is all we can do now. Endless hypotheticals do nothing at this point. I'm working on my golf game :).
This wait is driving investors here crazy!
I cannot wait for results. Almost a reality show starting on this board! I'm done until I here from clinical study results.
http://emedicine.medscape.com/article/283252-treatment#d5
The treatment of glioblastomas remains difficult in that no contemporary treatments are curative.[23] While overall mortality rates remain high, recent work leading to an understanding of the molecular mechanisms and gene mutations combined with clinical trials are leading to more promising and tailored therapeutic approaches. Multiple challenges remain, including tumor heterogeneity, tumor location in a region where it is beyond the reach of local control, and rapid, aggressive tumor relapse. Therefore, the treatment of patients with malignant gliomas still remains palliative and encompasses surgery, radiotherapy, and chemotherapy. See Brain Cancer Treatment Protocols for summarized information.
Upon initial diagnosis of glioblastoma multiforme (GBM), standard treatment consists of maximal surgical resection, radiotherapy, and concomitant and adjuvant chemotherapy with temozolomide.[24, 25] For patients older than 70 years, less aggressive therapy is sometimes employed, using radiation or temozolomide alone.[26, 27, 28] A study by Scott et al found that elderly patients with glioblastoma who underwent radiotherapy had improved cancer-specific survival and overall survival compared with those who did not undergo radiotherapy treatment.[29]
Recent evidence suggests that in patients over 60 years old, treatment with temozolomide is associated with longer survival than treatment with standard radiotherapy, and for those over 70 years old, temozolomide or hypofractionated radiotherapy is associated with prolonged survival than treatment with standard fractionated radiotherapy. The improvement in survival with temozolomide isenhancedinpatientswithMGMTpromotermethylation.[30]
Stupp et al reported the final results of the randomized phase III trial for patients with glioblastoma who were treated with adjuvant temozolomide and radiation with a median follow-up of more than 5 years. Stupp et al previously reported improved median and 2-year survival when temozolomide was added to radiation therapy in glioblastoma. Survival in the combined therapy group (ie, temozolomide and radiation) continued to exceed that of radiation alone throughout the 5-year follow-up (p< 0.0001). Survival of patients who received adjuvant temozolomide with radiotherapy for glioblastoma is superior to radiotherapy alone across all clinical prognostic subgroups.[45]
Median time to recurrence after standard therapy is 6.9 months.[46] For recurrent glioblastoma multiforme, surgery is appropriate in selected patients, and various radiotherapeutic, chemotherapeutic, biologic, or experimental therapies are also employed.[47, 37] A study by Wernicke et al report that prostate-specific membrane antigen is expressed in the vasculature of GBM vessels and represents a potential novel therapeutic vascular target. Future clinical trials are planned.[48]
This statement makes no sense at all.
Why would they plan for events to happen sooner?
What are you talking about? Lets plan for patients to die early? Really? ??
"But I have since shared it with you, so now you know when the protocol was expecting those events to hit. I explained to you why their statistical protocol assumptions are wrong. They planned them to occur too soon. Period"