Replies to post #150460 on Avid Bioservices Inc (CDMO)

[biopharm]

You missed the point. Accelerated Approval can be based on blood samples. The Pcr was mentioned as an example...as it was used for FDA approval with Roche via blood samples. You think 200-300% overall response rates provided by Bavi combos will not be something of interest? : )

Its more like who is not interested. PS is the target.....it will remain the target.

Happy Turkey Day JQ

[biopharm]

Your ph2 trial didn't have any CR

Are we absolutely positive that there will be no CR's reported at ASCO this year? Fortunately.... we don't have long to wait now and as for blood samples to determine and act as that "surrogate endpoint" of overall survival, maybe the Bavi+Yervoy trial is a very good indication if blood tests will be part of Phase III "SunRise" NSCLC:

Peregrine Pharmaceuticals Announces Initiation of an Investigator-Sponsored Trial Combining Its Immunotherapy Bavituximab and Ipilimumab (Yervoy(R)) in Advanced Melanoma

April 23, 2014

The primary endpoint of the trial will be safety and secondary endpoints will include measurements of disease control rate (DCR) and overall survival (OS). In addition, tumor biopsies will be collected at screening to measure changes in myeloid-derived suppressor cells (MDSC), tumor-associated macrophages (TAM), T-regulatory cells (Treg) and peripheral blood cytokines. For more information on this trial please visit ClinicalTrials.gov using the identifier NCT01984255.

Preclinical Combination Data of PS-Targeting Antibody and Anti-CTLA-4 Antibody

Preclinical data have shown that phosphatidylserine (PS)-targeting antibodies reactivate tumor immunity at multiple levels and that the combination of a PS-targeting antibody equivalent to bavituximab and an anti-CTLA-4 antibody, an FDA-approved immunotherapy, resulted in superior tumor growth inhibition than with either antibody alone, with no additional toxicity following multiple treatment doses. In addition, histopathological analysis showed the combination produced more inflammatory cell infiltration and tumor destruction than anti-CTLA-4 alone.

http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=841892

Looks like no one in their right mind will be looking to seek medical treatment with a Yervoy trial without Bavituximab after the initial results come back here...... that would support PS Targeting agents as the superior piece of the puzzle that has been missing for decades. Also, it does not mean that the profits are split 50/50, because Bavi can be combined with many others just as well..... does not even need Yervoy. This is what they call a "checkmate" trial.... which BMS has had quite a few trials named along those lines in the past. The checkmate days are soon to be over.