Good morning,
I was delighted to see that Ken, (the Professor) had agreed to share his post on HC, so it runs a little wider than the current 34 on his mailing list, one of which is myself.
The Professor is an educated and well researched writer. He certainly has a better ‘grip’ on what is happening in the IMU world than almost all here, and he has an excellent understanding of the science, in my opinion.
I recommend that HC readers explore all aspects of the Professor’s post because it is an excellent summary. It should answer many of the questions I see bouncing around on the IMU threads.
I would especially draw your attention to this part ...
“The FDA was never going to approve Vaxina for all cancer indications--all at once. There's no such thing as "blanket" FDA approvals. There's no magic wand. Going forward IMU will have to run trials and make FDA applications for each cancer indication that Vaxinia addresses.
With IMU's limited financial resources it was always going to be a case of "which cancer indication(s) to submit for FDAapproval". No matter how many cancers Vaxinia was capable of curing! IMU has clearly set their sights on gaining FDA approval for cancer indications with a high unmet need. Cancer indications with a very low bar in terms of gaining quick FDA approval. IMO, a small company like IMU would be unlikely tomanage more than 3 or 4 FDA registrational trials at any given time.”
The MAST study is designed to do many things (look at safety, look for signals, find trends, understand how different patients will respond, etc). In my opinion it was never intended to roll through as ‘a cure all’, so to speak. It is a study (or sandbox trial) that will offer many, many clues as to which cancers to target first, which patients to enrol, what doses to use , etc, etc. In my opinion it is doing all this. IMU wants the best chance of success for each expansion trial. If it achieves success in several cancers, it can ‘do a Keytruda’, and expand its range and become very widely used. Perhaps even become the ‘go to’ in solid cancers. We must remember what the MAST study is actually intended to do.
As the Professor explains, IMU is still a small company and this is the game it must play. I believe the divesting of the North Carolina facility was a good financial move, after all, what they really wanted was a powerful and effective ‘allo’ CAR-T.
As for timelines, that’s a tricky one. If I had a seat on the IMU board, I would know ... and of course, I wouldn’t be allowed to share.
Anyway, just some Sunday musings. Now back to the packing. Enjoy the rest of your weekend.
As always, opinion only.
(20min delay)