Avid Bioservices Inc (CDMO)

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Dia, Merck, (MRK) has a very powerful anti-PD1, MK-3475 in phase3, that is being run against advanced non-resectable melanoma with ipilimumab as the control. MRK had an 81% survival rate in the phase2 at one year. The trial had mainly grade 1 & 2 toxicity.

http://www.ncbi.nlm.nih.gov/pubmed/23724846

Merck seems really aggressive with this anti-PD1 candidate, apparently running 31 trials and spending $2 billion per quarter. They have a 'Breakthrough' on it and are running the phase3 with a rolling submission to the FDA of a BLA for patients that have previously been treated with ipilimumab, which we will recognize as Yervoy.

They appear to be running straight at BMS and their anti-PD1, nivolumab as well.

So I think from what Peregrine has learned in the combination immunotherapy studies with anti-CTLA4 and anti-PD1, is that this next immunotherapy combination trial, using an anti-PD1 mAb could be an eye opener for certain BPs that may be currently engaged in talks with Peregrine.

What could happen with the initial response rate if MK-3475 was to be combined with bavi? In the phase2 trial, MK-3475 had a best response rate of 52%.

This is where we should see the initial boost predicted by Dr. Brekken, and demonstrated in pre-clinical studies, (+200% to +300%) in response rates.

If you can get 81% one year survival with 52% of the patients...what do you get when you boost the 52% to 90% or better?

We will see, because a bavi plus anti-PD1 trial is up next!

IMO

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