NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It was a Phase I safety trial, however, your description of results is inaccurate. I have not gone back again to do a more thorough presentation, but this should suffice for now:

Using the MDACC Score, predicted survival was determined for all DCVax- Direct Phase I patients and compared to actual survival (the MDACC Score was calculated from patients treated with other experimental therapies)

Outcome: 76% of evaluable patients in the DCVax-Direct trial exceeded their predicted survival time, by an average of 14.3 months*

As for survival data, and again, all of these patients had exhausted their other treatment options and were effectively on their way to hospice, and as of the 2019 ASCO presentation that Bosch gave:

3 of 25 patients still alive at 7 years.
5 of 25 patients lived > 5 years
10 of 25 patients lived > or = to approximately 3 years
Median Survival was 21.5 months

Expected mOS on SoC: 15 – 17 months

https://vimeo.com/340029244

If I can yet, I'll dig for more later.

Tumor response was a secondary measure. Primary outcome was safety.

Key exclusions:

Heavily pretreated (HP) subjects are not eligible for this study, unless treatments have occurred more than 1 year in the past.

Prior active immunotherapy for cancer within the past 2 years.

The poster on the iHub page above is not dated but does not go out as far as the 2019 chart, which goes out to 96 months with a list of patients living well beyond the Expected mOS indicated. I don't know how many are still living, but we know of at least one who has been very public about his treatment.

I believe that because it was a safety trial, they only injected one tumor, but also saw systemic immune response, though the details I do not have and that is to the best of my recollection.

All of this is IMHO, please everyone, do your own due diligence and confirm whatever I have offered from my memory and quick review.

I think the expectation is, if treated earlier, the DCVax Direct vaccine will likely do much better than this, and that with combination therapy, it is also very likely that patients would potentially be able to be studied as they are in the DCVax-L trial to understand their immune reaction and correct any immune reactions that may interfere with the effect of the treatment with checkpoint inhibitor drugs or CSF-1Ri / PLX3397.