Replies to post #268518 on Avid Bioservices Inc (CDMO)

[eb0783]

Good post entdoc. Your question on side-effects did bring in a good all around picture of the side-effects found. In this post you mention one of the things that some of us have been "harping" about over the last few years especially. Many have not yet grasped it. [my underline]

In other words, as stockholders we need to be vigilant about not allowing the platform to be given away.
In this business of clinical trials what we learn about possible"spin-off" applications of a "new discovery" is sometimes more important than what we learn about the original intended application.

Some of us have listed numerous general applications and some have made long lists of potential applications. Hence the progression toward ASTRONOMICAL.

[Protector]

entdoc, the safety of Bavituximab is not a NSCLC or any other combo specific topic. One must look to ALL bavituximab clinical trials.

Bavi was always safe and if it would, in a specific combination, become not safe then it would have to do with the combined drugs.

In the yervoy CT Bavi has been given alone for two rounds before starting yervoy+bavi treatment. That trial FOR SURE has measured toxicity of Bavi alone on Humans too.

To doubt the overall safety of bavituximab (abstracted from the combo effect with a specific drug) we must doubt about a lot of main investigators at this point, incl. Thorpe/Brekken Lab people, Dr. Stopeck, Dr. Yob, etc that all came to the conclusion that in their combinations Bavituximab was safe and well tolerate and has no significant side effects of its own. And infusion reactions are not proper to bavituximab.

As for inflammations and infections. here we enter the MDSC and Dendric cell maturation domain and Dr Gabrilovich's area. What is IMPORTANT to remember is that Bavituximab works LESS GOOD with Chemo then with Immuno therapy. hence the observations of reduction of MDSC's and maturation of Dendric cells comes from the I-O combo preclinical data and NOT from the chemo combo pre-clinical.

I think, SPECULATION, that chemo is so destructive of cells (cancer and healthy ones body wide since it has no targeting mechanism) with such huge amount of Phosphatidylserine exposed as a result that the immune system is suppressed at an extend that infections can party in the body.

I think that Bavituximab at the current dosage (3mg/Kg) milds it but cannot completely stop it. Higher dosage needs testing as Bavi may at some dosage point become toxic too (we don't know but even WATER becomes toxic if we drink it and it dilutes the electrolytes we need).

In Imuno-therapy that overwhelming immune system suppression effect seems not to be there. Hence Bavi gets a better chance of doing its work and infections are taken care of by the immune system.
no IL-10 and IL-12 instead -> MDSC[PS-R< (<PS] (PS can't bind PS-R).

PPHM has added Inflamations/Infections to their list of Bavi application about 2 years ago if my memory is correct.