NorthWest Biotherapeutics Inc (NWBO)

[sharpie510]

No matter if the MHRA initial approval is for (A) new and recurrent glioblastoma, (B) grade 3 and 4 gliomas, or (C) any solid tumor cancer, demand is going to overwhelm the supply in the beginning, so it would make sense to provide DCVax-L using a benefit-based and/or treatment of last resort consideration. Likely the mesenchymal subgroup would be high on that list, as they tend to do the worst under standard of care but respond best to DCVax-L. So maybe many mesenchymal recurrent gbm patients will get the vaccine first, and recurrent patients arguably need the vaccine the soonest. Eventually, the pool of eligible patients that can have access will increase as Flaskworks automation kicks in. While some subgroups did better than others, all patients seem to benefit from the vaccine, so eventually all should be able to access it.

Dr. Keyoumars Ashkan at ASCO 2018, 51m17s:

We also have to work with the regulatory bodies, and we probably ought to do that now, right, not even waiting, because we want this to be available to all the patients. Again, while it’s very nice about these studies… yes, those patients who are in better prognostic groups are going to benefit more… but there is a benefit to all patients. We want this available to absolutely everybody.

Webcast: Dr. Marnix Bosch’s Presentation on DCVax® Personalized Dendritic Cell Vaccines from ASCO 2018

Dr. Linda Liau at the Neurosurgery Grand Rounds, 22m14s:

Interestingly, the patients who actually saw the most benefit from immunotherapy was in the mesenchymal subgroup and that's actually the poorer subgroup. Those are the ones that are idh1 wild type, MGMT methylated or non-methylated, it actually was in both populations, but those are the ones who typically have, a you know, median survival of about 14 to 16 months. So in that group, we, you know, the vaccine actually did seem to show a significant difference, and actually all our long-term survivors were in the mesenchymal subgroup. So there's something about that particular subgroup, um that you know, I think is, you know, inducing a better, uh perhaps, immune response for these patients and that's kind of what we've been studying for the last you know five or six years now.

Immunotherapies for GBM: Tumor Vaccines by Linda Liau, M.D., Ph.D., M.B.A.