Replies to post #52815 on NorthWest Biotherapeutics Inc (NWBO)

[Ready4bluesky]

"Pseudo progression wreaks havoc with trials"

So, why does Dr. Bosch believe this? Has he had any first-hand experience with clinical trials where this occurred? I think the answer is a resounding yes and is one of the missing pieces to this whole mystery.

[Evaluate]

For some of Marnix Bosch comments, see my post 52707 ... as well as follow some of the other links in reply to this post as well as comments made by other posters just prior to & just after post 52707..
Keep in mind that he did not make a formal presentation, and was just providing some general comments as a Session Chair. I certainly did not get his comments verbatim ... so this was more just bullet point type summary of his comments as I caught them & what I believe he was saying.

Post 52707:

Marnix Bosch mentioned some issues about challenges in immunotherapy trials:
1. Pseudo progression wreaks havoc with trials
2. Might need to go to Overall Survival for primary trial endpoint in future trials, which could cause trials to take a lot longer.
3. Quality of Life - often QOL is improved, but currently blunt measurements of QOL .... Soft endpoint currently.

Others mentioned/discussed:
With vaccines it is a numbers game; Not enough T cells in the system.
Vaccines have not shown much efficacy in the past, even with adjuvants.
CI have some safety issues.
Regulators are risk adverse regarding combinations, commencing with Phase I trials. Test pre-clinically - is difficult ... What is relevant animal model? Challenge = how to get quickly to combinations that work.
NCI: reviewed many trials - most vaccines are found to be inert & safe. Might be able to skip Phase I to add more easily in combination.