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JAMA JAMA? JAMA JAMA
Good stuff
Yes indeed.
Been invested since 2014.
JAMA JAMA? JAMA JAMA
Same,
Been in Northwest since 2014. Looking forward to Tuesday.
Good stuff Flipper,
It would seem they are patenting the use of IL-6, -8, -12 and/ or TNFa as markers of sufficiently matured dendritic cells (without need of comparison of immature); versus patent examiner earlier rejected as a comparison for matured vs immatured via IL-8, -12 as markers only
Strength of this would be in whether having these 4 markers analyzed, specifically, is the best bet or another combination is just as sufficient (i.e. there were supposedly 15 markers that can help predict). One would think Northwest picked the best/ most predictive for consistent outcome (that matured dendritic cells in this way were linked with good patient outcome). The fact they are patenting this analysis is great for Direct in that they can optimize for response in future trials (similar benefit of a PD-L1 test prior to PD-1 treatment) - if matured cells in this manner more likely patient's immune system properly trained by their dendritic cells to attack tumor.
Not arguing your flawed postion that an mRNA vaccince has the chance to genetically modify. Give a real mechanistic possibilty from the literature instead of changing the topic to other non-evidenced based possibilities.
And our own cells could be causing cancer from any number of enviromental insults. Leaving the rabbit hole. Good bye
Seriously, now you use a generic topic of chronic inflammation, by that logic we'd all be dead from various causes of chronic inflammation
By what proposed mechanism would the mRNA lead to genetic modification by insertion into the chromosome?
mRNA degrades in hours in the cytoplasm
mRNA is exported from the nucleus, not imported
Any chance the mRNA coding covid spike protein is even remotely similar to the structure of a tRNA that can go through nuclear import for further processing?
There a ribonucleoprotein it can hitch a ride into the nucleus with?
COVID vaccines using mRNA are not effecting genetic change in the way I think you are thinking about this. mRNA is delivered into our cells and its message is read by the cell's machinery to make protein. The protein coded is COVID's spike protein. Once it is on cell surface recognized as foreign by the immune system and immune reponse ensues.
Genetic change would be something like CRISPER or an adenoviral vectory for gene therapy, there the aim is to correct a gene via edits to DNA in nucleus of the cell. This is modification and persists.
There is no deniability, public knowledge on EU registers.
Seems you rather they analyzed the trial on a chemo PFS type endpoint instead of appropriately for immunotherapy.
Trash doesn't get the benefit of dignity
NWBO management can decide to PR endpoint changes or not, it's public knowledge on EU registers
Personally, I'm just fine the way it is, been in this for 7 years, nothing new to me, and having been part of a startup previously can completely understand the low profile as it is a waste of time to defend against garbage as it just a time/ money waste of limited resources
This should be a sticky post.
It summarizes the innuendo and implied crap that has been pervasive in writings in dissent of NWBO case.
It's important new investors recognize this.
Amazing Flipper, no 'I don't recall' for the fox
And Dendreon had a one antigen wonder, one indication, manufacturing not ready for prime time, payers not ready on how to reimburse.
Fast forward to a multi-antigen personalized treatment. Every tumor indication whether operable or not. Many years of manufacturing improvements (Linda talked about how it is better than Dendreon like 5 years ago). Diversified multiple sites for manufacturing. And many targeted and immunotherapies to lead the reg path now.
Not a good comparison period. Not anymore.
Guessing work by their students in academic lab, still looks good.
Couple of phd candidates listed
DEDUCED RECKONING: Northeest Biotherapeutics is finally ready for prime time
https://www.heraldtribune.com/story/business/2020/10/14/deduced-reckoning-northwest-biotherapeutics-ready-prime-time/3656047001/
Great reference, love it!
I agree here also. Usually when info is submitted, if no comment within 30 days and that time lapses you know it is okay to proceed. You can ask specific questions and request a response, but outside SPA it is more of "okay to proceed". SPA is different and more of guarantee in a way, if we do/show X, we can get approved. Happens with rare disease (although could be under orphan instead) or great unmet need.
None other than Pyrhorian or whatever he called himself years back on this board and yahoo board, one day woke up and suddenly was a vociferously a short as he was previously a long. LMAO
You must be right, despite other immunotherapies using iRANO for analysis, all that talk with experts and updating, they must of just said F it we'll stick with RECIST for an IA back when everyone already knew immunotherapies should be analyzed differently but rules were still being worked out in 2015, so they went ahead with an outdated method that would have falsely indicated progression. Then proceeded to drag on 5 more years with like 50 neurooncologists all in on it just say gotcha in a couple weeks time. Bravo!
Yes, a price to pay of foreign companies, not a good idea.
$10 sounds great near term and is in line with kite/juno type valuation
Only been waiting 7 years
Maybe he just removed info to have less message board posters calling and emailing
Relax I made a mistake, it had an update date from today, sorry to put you out
I'll stop posting and go back to waiting, 6 years and counting
Sounds good to me
Recruitment says suspended now but ( ) says final contract negotiations
Thought compare link would be helpful
Thought the compare link would be helpful
BMS Collab Study Updates with August 7th:
https://clinicaltrials.gov/ct2/history/NCT03014804?A=1&B=12&C=Side-by-Side#StudyPageTop
Looks like update of title but also start date of Dec 2019, primary completion Dec 2020, study completion Dec 2022, whereas previous had 2017 (grossly outdated)
BMY screens patients differently vs how Merck did.
The PD-L1 test for nivo is 1% positivity whereas pembro had the 50% cut-off for enrollment.
This decision by BMY has bit them and it allowed Merck to catch up, surpass, and now they are entrenched in the lead for anti-PD-1 in lung.
Nice, I feel finally that there are not too many pieces left in completing this jigsaw puzzle.
Select Novel Approaches to Glioblastoma—Part 2
Published in Oncology and Expert Opinion / Interview · April 10, 2019
Interview with
Steven Brem MD
Interview by
Aman Shah MD
https://www.practiceupdate.com/content/select-novel-approaches-to-glioblastoma-part-2/76518
Dr. Shah: So, we spoke earlier in part one of this program about some of the new research that you’re doing with DNA vaccines and conjugates with Pseudomonas toxin. Could you tell us some other interesting research you’re doing on novel therapies in neuro-oncology?
Dr. Brem: Yes. We just completed a study with Tocagen, which is a viral therapy, which will also stimulate the immune response and also uses a novel form of chemotherapy where it takes an antifungal drug that is converted genetically to an oncolytic drug. So it’s a very clever approach, and that’s a large multi-center study and that’s being analyzed right now. And we learned at this meeting that their plans to roll out a new trial through the NRG for newly diagnosed using viral therapy and we’ve heard of the poliovirus, we’ve heard of the many viral studies coming from multiple centers in Boston, Houston, and so on, and about viral therapy. And whatever the virus is, they all are oncolytic. They kill the new glioma cell, liberate new antigens, or neoantigens, which are then recognized by antigen presenting cells.
We’ve also been very active in the DCVax, which was started at UCLA but now extended to Penn and other sites. And the interesting thing of that trial, which we reported some preliminary data, is that a large percentage of the patients are now living beyond 3 years, so that is a unique approach in that the patients own tumor creates their very individual vaccine looking at their own panel of antigens. So we’re excited by that approach and we’ll be hearing more about that in the future.
Dr. Shah: Okay, so my understanding of the DCVax is that you have to take the tissue out and then generate something against the dendritic cells within that admixture.
Dr. Brem: Yes.
Dr. Shah: Could you tell us a little bit more about where that therapy stands as of now and what kind of efficacy we're getting?
Dr. Brem: Well, a very large multi-national study was concluded and so that is going to…as the data matures, that will be going to FDA. We hope that that gets approved. We don’t know, but it’s an exciting study.
Dr. Shah: Okay, so talking about getting tumor cells out and generating something against it. It seems that you are also either working on or are involved with CAR T cells in glioblastomas, so please walk us through how that works.
Dr. Brem: Well, that is an exciting effort. It’s being led at the Abramson Cancer Center by Donald O’Rourke and his team, Zed Binder. I’m involved in that group, and it has just been funded by the Abramson Cancer Center as a translational center of excellence, so there’s a huge effort underway with neurosurgery and the Parker Institute, Abramson Cancer Center, Carl June’s Laboratory, many other laboratories trying to develop the next generation of CAR T cell. So we are…we just published a first-in-man phase I human trial that showed biological activity. And now because we’re dealing with a tough foe, the glioblastoma, we’re working on potentiating this by taking down some of the tumor defenses, looking at checkpoint inhibitors, combining it, supercharging the CAR T cell vaccine in a combination therapy, so that will be the next generation. That’s the future.
Dr. Shah: So, my understanding is that perhaps part of the reason why PD-1s have not been as promising in glioblastomas is glioblastomas somehow seem to not be very rich in T cells when you sample them, so there’s something stopping them.
Dr. Brem: There’s stromal barrier and there are inhibitors like TGF-ß, IL-6, the TNF-a, there’s cytokines. Also, we’ve been very interested in looking at macrophage polarization. And I’m part of a group that published this year in Nature Communications led by Yi Fan, who presented at this meeting, showing that if you block IL-6, you could redirect the macrophage from a tumor-suppressing state, the M2 state, to the M1 immunostimulatory state, so we hope to partner with pharma on that and develop the clinical trials based on that discovery.
Dr. Shah: That is fascinating, and of course, the CAR T cell strategy makes perfect sense because you create them in vitro and then put them in.
Dr. Brem: Yeah, so ultimately, we feel by attacking the tumor microenvironment as well as creating a vaccine directed to the antigens on the tumor, we’re going to have really a new class of therapy.
NW Bio Hires David Innes As Vice President, Investor Relations
31 Years Managing Portfolios At Several Major Wall Street Firms, With Emphasis On Biotech
https://www.prnewswire.com/news-releases/nw-bio-hires-david-innes-as-vice-president-investor-relations-300802270.html
BETHESDA, Md., Feb. 26, 2019 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that it has hired David Innes as Vice President, Investor Relations.
Innes comes to NW Bio with over 31 years of managing portfolios at major Wall Street firms, and a degree in biology. For the last 10 years, Innes has worked as Senior Director-Investments at Oppenheimer & Co., LLC. At Oppenheimer, Innes managed over $175 million in assets with a concentration in emerging biotech companies, including as an advisor to many shareholders at NW Bio. Prior to Oppenheimer, he spent 20 years at UBS, including 10 years as a Vice President of Investments.
Innes noted, "After decades of focusing on small to mid-cap biotech and biomedical companies, I was attracted to NW Bio by what I believe is their broad potential, due to their approach to addressing the complexity of solid tumors which comprise most cancers. Their DCVax technology is precision-tailored to a patient's cancer, while also designed to mobilize a broad-spectrum attack on the cancer. As such, I believe NW Bio's DCVax technology has the potential to be a meaningful therapy for many types of solid tumor cancers."
"I am honored to be joining NW Bio at this pivotal time in the Company's history. I look forward to further strengthening the relationships with both current and prospective retail and institutional shareholders, as well as communicating this DCVax immunotherapy's potential to an ever broader marketplace."
Linda Powers, CEO of NW Bio, noted, "We are pleased to have someone of Dave's experience in the biotech investment community joining us. We see this as an important initial step in expanding our team with first class personnel as we move toward completion of the Phase III DCVax®-L trial for GBM and initiation of Phase II DCVax®-Direct trials. Welcome aboard Dave."
Current State of Immunotherapy for Treatment of Glioblastoma
Open Access
Neuro-oncology (GJ Lesser, Section Editor)
First Online: 21 February 2019
https://link.springer.com/article/10.1007/s11864-019-0619-4
For patients who have surgically accessible disease, custom vaccines are a promising area of clinical research. These vaccines require a minimum volume of resectable tumor to generate a custom vaccine, which limits the population of eligible patients.
DC-Vax-L uses whole tumor lysate to pulse patient-derived DCs. Currently over 10 years from diagnosis, some of the patients enrolled in the original phase 1 study of this vaccine are still alive [43]. The phase 3 of DC-Vax-L in newly diagnosed GBM results is still blinded; however, recent reports described a mOS of 23.1 months for all participants (90% of whom received the DC-Vax-L treatment due to crossover design). While the data remains blinded, there are concerns that this may only be interpreted as a single-arm study of 331 patients due to cross over as a result of pseudo-progression and not true progression [44•]. Again promising are reports of durable responders in the phase 3 with survival exceeding 7 years. This vaccine is also being studied in a phase 2 clinical trial in combination with the PD-1 inhibitor, nivo (NCT03014804).
Looks like whole of info is there without subscription.
PracticeUpdate - Dendritic Cell Vaccines for Glioblastoma
Interview with Dr. Wick on DCVax
https://www.practiceupdate.com/content/dendritic-cell-vaccines-for-glioblastoma/75609/7/1/3
You can listen to video or read text. Text is cut short, anyone have full access can post?
Therapeutic Immune Modulation against Solid Cancers with Intratumoral Poly-ICLC: A Pilot Trial
Of interest, just published, Dr. Bhardwaj corresponding author:
http://clincancerres.aacrjournals.org/content/24/20/4937?utm_source=ETOC+Master&utm_campaign=62d411920d-EMAIL_CAMPAIGN_2018_10_15_01_15&utm_medium=email&utm_term=0_aae0ec8d4d-62d411920d-160681593
Conclusions: Poly-ICLC was well tolerated in patients with solid cancer and generated local and systemic immune responses, as evident in the patient achieving clinical benefit. These results warrant further investigation and are currently being explored in a multicenter phase II clinical trial (NCT02423863). Clin Cancer Res; 24(20); 4937–48.
NCT02423863:
In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol® (Poly-ICLC)
https://clinicaltrials.gov/ct2/show/NCT02423863
Nature Outlook post with Dr. Liau quoted with mentions of DCVax posted today:
https://www.nature.com/articles/d41586-018-06705-6?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+nature%2Frss%2Fcurrent+%28Nature+-+Issue%29
Good to hear. Wish we saw these stories more often. Seems so much easier for these characters to cheat and not get caught or get caught for a disproportionately small penalty compared to damage done, but better than not at all.