Avid Bioservices Inc (CDMO)

[bimerkjaere]

Highly cited paper on pancreatic cancer recommends a 2 month minimum improvement in PFS and OS before moving to Ph III. See link below.

Due to bavi MOA, we can forgo the PFS requirement with a strong OS signal. I would suggest that if we see something around 9mos or better for MOS, potential partners will be interested in moving bavi to Ph III in pancreatic (typical OS for gem is around 6 mos, but has been as high as 7 mos).

This 9 mos threshold is also important as bevacizumab (Avastin) showed 8.8 mo MOS in its Phase II prior to entry into Ph III (note that it ultimately failed in Ph III). There have been others that have brought forward candidates with less of an improvement in OS (e.g. axinitib with 6.9 mos MOS), but all have failed in Ph III.

Although 9 mo MOS would not guarantee success in Ph III, it should act as a threshold to get big pharma's attention. Currently, we are 7 mo post completion of enrollment (June 2011), and 24 months since start of trial. My estimation is that we are already likely looking at 8-9 mos OS if results were reported this month - hope they are not.

It is important to recall that pphm has already given an update on pancreatic trial in June 2011 with AACR presentation. Recall that enrollment was completed later that month. The poster included 66/70 patients (bavi+gem = 32 patients, gem = 34 patients). Only part of patient data was disclosed for response, with Bavi having 4/15 (27%) response rate vs. gem 2/17 (11%). Compare bavi's 27% response rate to Avastin's 21% in its Ph II. As for OS, bavi's responders ranged from 5.6 mo - 12.7 mo (median of the 4 was 7.5).

The only other pancreatic trial that pphm has done was a preclinical in 2006. Compare the safety profile of this trial to current Phase II and you notice similarities in vascular effects. From researchers in PC trial: "The lack of toxicity to normal vasculature of 3G4-based therapy is likely due to the specificity of PS exposure on tumor endothelial cells" The study also showed reduction of metastases, tumor weight reduction, and 'marked differences in the clinical course of the animals...' (bavi arm much healthier, although OS not mentioned). At the molecular level, there were signs of improved macrophage infiltration with bavi arm, as well as some alteration of tumor vasculature (although minimal).

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http://www.24hmb.com/UpLoad/Editor/2010/1/27/2010012761108861.pdf

insert-text-herehttp://onlinelibrary.wiley.com/doi/10.1002/ijc.21684/full