Replies to post #582534 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Those who don’t like the P3 crossover design can forget it altogether and focus on the current and upcoming combo studies. The combo trial at UCLA has a placebo design.

Don’t miss the NYAS event this year! It looks like PD1 combo will be a central topic.

NYAS Frontiers in Cancer Immunotherapy 2023

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171539116



https://events.nyas.org/event/b42eef99-1a18-41dc-9322-17c52d483a4a/websitePage:37d65bb7-80d5-47e9-a98f-19c48581a063

[SkyLimit2022]

Luckily for the naysayers who want more evidence, there are data beyond just the P3 and data from multiple clinical investigations. Here are some additional data highlights from compassionate use…

March 2023 presentation by Dr. Bosch:

http://nwbio.com/wp-content/uploads/NWBT-GBM-Summit-slides-3-15-23.pdf




The P3 was brilliantly executed and is more than adequate all by itself, but the application(s) for approval will require lots of paper clips and plenty of staples for all the extra pages that will be included—there is a voluminous catalog of supportive data that has been collected, analyzed, and validated.

Data collected from the P3 and ECA comparison only comprise a fraction of the clinical efficacy data that exist for murcidencel today. DCVax-L has been studied in multiple trials—only one of those trials relied on an ECA, and that ECA included over a thousand well-matched contemporaneous patients.

All clinical data are relevant to a regulatory application including those data gathered from other studies, interim analyses, and compassionate use. All the DCVax-L trials have produced substantial safety and efficacy data, and two of the three clinical trials ran for over a decade with survivors alive today.

https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

[Lykiri]

Group Leader : Prof. Denis Migliorini
Brain Tumor and Immune Cell Engineering Group – BTICE Group

Tumors arising in the brain are notoriously hard to treat. Intensive research in the last decade provided in depth characterization of the molecular profile of high grade gliomas, but unfortunately no impactful novel therapies. We contributed to immune based therapies for gliomas, especially in the identification of overexpressed cell surface markers of GBM in vivo and with the development multiepitopic vaccinations using synthetic peptides. We had the opportunity to translate our research into the clinic in an early phase trial where 19 patients with newly diagnosed GBM tumors were treated with the IMA950 peptide vaccine. We were able to demonstrate safety and immunogenicity. This endeavour led to another ambitious phase I trial using a personalized vaccination approach adapted to each patient’s tumor molecular profile.

Our next endeavour is to develop improved chimeric antigen receptor (CAR)-T cell approaches for glioma for the development of successful translational programs. T-cell engineering allows the construction of cell products harboring a high-affinity single-chain fragment variable (scFv) specific for a target of interest, fused to domains necessary for full activation and costimulation. CAR-T cell therapy in the context of brain tumors is promising because glioma is a good example of how specific improvements in trafficking, persistence, and resistance to the immunosuppressive factors related to the TME will be especially critical for success of engineered cellular therapies. We are fortunate to benefit from the generous support of the ISREC Foundation and to be part of the newly formed Swiss Cancer Center Léman (SCCL) which brings together fundamental, translational and clinical cancer research experts from Geneva and Lausanne. The SCCL federates skills and ressources at the cutting edge of the fight against cancer and allows us to integrate our efforts in a wide multidisciplinary community."

https://www.unige.ch/medecine/demed/en/groupes-de-recherche/denis-migliorini/

[skitahoe]

Lykiri,

There is no doubt that knowing all that's known today if a new trial were starting for DCVax-L it would have been done differently. There are a few Drs. willing to fight for NVCR's way of treating GBM patients, though they often don't say so. They'll say they have no conflict and recommend more testing, but I believe the regulators can see through what they're doing and saying.

It's sad, but a friend testifies in medical cases and while such people may not lie, they tell the story in the manner that benefits those who're paying them. That's what these so called experts are doing.

I believe that if the regulators ran the trials themselves the changes that were made would be little different. Pseudoprogression which can't be differentiated from actual progression completely invalidates a PFS goal. Overall survival was always a goal in the trial, and clearly it's the gold standard for judging trials. With the trial designed to cross over from the beginning it was clear that no real control group would exist for the OS goal, the trial wasn't changed to say this, it was there from the beginning. Certainly a few patients didn't cross over, but not enough to be a real control, and many very probably because they passed on before they had the opportunity to do so. Doctors who argue the trial was flawed because of this clearly have their own agenda,

Gary

[CrashOverride]

Novocure shills promoting stone age cancer treatments.

[sentiment_stocks]

It seems that groups of a feather stick together.

[HappyLibrarian]

Critical review of the report on the DCvax-L trial: the trial did not meet its prospectively defined endpoint and post-hoc analyses with poorly selected external controls do not replace a proper prospective trial[emphasis added].

Hopefully regulators do not share this opinion because needless to say patients not NWBO cannot afford another Phase 3 trial.

If a new trial is imposed by the FDA but the UK approves without that then we might be able to survive long enough for real world proof of efficacy to prompt a revisit of that decision.

Under such a scenario it might be better to just go with using Direct in a Phase 3 for an indication where patients event rapidly and try to negotiate where if patients live past a certain time that we don’t have to wait until they event (in short we don’t punish patients for living longer).