hutschi, thanks. I hope this good news about FDA and Canadian/European/etc approvals of the new Immuno-Therapy drugs keeps coming in.
For PPHM it is important now that as much as possible of these are approved because we now have affirmations from world call research facilities such as memorial Sloan Kettering, but also Rutgers, UTSW, etc that Adding Bavituximab to such IO agents is a BIG improvement to the tumour environment and allows those drugs to perform on a much larger patient foot print and less killing side effects. Besides that Bavituximab reduces (or possibly eliminates - to be confirmed) RELAPSE.
Opdivo and Yervoy alone have a 25/30% foot print and an endless list of side effects (and related lawsuits when patients got killed). However, for those for which it works the average RELAPSE is expected to be in the range of 2 years (although commercials kind of trick you in believing that you get cured and live long happy lives with your grand-children which is, IMO, deceptive).
With Opdivo+Yervoy (and comparable combinations from other PD-1/CTLA-4 drugs) the footprint goes down to about 20% but the side effects increase. However side effect for those for which it works seem to be much less (which is the merit of this combination). No relapse data is available but it should be in the same order or maybe some more then the 'alone' versions.
The companion-tests allow to single out the responders to the above PD-1 treatment and (not sure) possibly also to CTLA-4 responders.
Bavituximab, with its new biomarker(s), allows to single out patients for which adding Bavituximab into combinations makes them responders to the above IO drugs (in the order of 60-70% vs currently 20-30%) and it diminishes the RELAPSE chance (or possibly eliminates it). Due to immune system activation it also milds the side effects.
That makes a big difference for BPs revenue potential, health Insurance companies and social security (e.g. Europe) budgets. But most of all for patients and their families.
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