Avid Bioservices Inc (CDMO)

[javier1973]

Peregrine Pharmaceuticals, Inc. (PPHM) was formed more than 30 years ago and has never been profitable. Their lead asset, bavituximab, has been in development since 2005; 735 patients have been treated in 16 trials and there is currently no visible path to registration. Despite the doom and gloom, Peregrine's top five executives feel justified in rewarding themselves with nearly $3MM/year in compensation; so much for pay for performance.

Bavituximab, a first-in-class phosphatidylserine-targeting chimeric antibody (having mouse and human components), is the centerpiece of Peregrine's pipeline. Phosphatidylserine (PS) is a phospholipid that is expressed on the surface of many cancer cells and cells undergoing apoptosis making it a logical target for cancer therapy.

Clinical development of bavituximab for the treatment of cancer began in 2008. Since that time, Peregrine has conducted twelve Phase-I/-II studies and treated 613 cancer patients but has yet to observe a statistically significant improvement over a contemporary standard-of-care (SOC).

Lung Cancer

Peregrine initiated a randomized Phase-II study of docetaxel ± bavituximab in 2nd-line NSCLC patients (N=121) in 2010. The results of the study were the subject of a recent press release in which the company reported that the "results from this Phase-II trial indicate a meaningful improvement in median overall survival of 11.7 months in the 3mg/kg bavituximab plus docetaxel arm compared to 7.3 months in the control arm (HR=0.73; p value=0.217)." To add to the hype, the company went on to say that "these compelling results strongly support advancing the 3mg/kg bavituximab plus docetaxel combination into Phase-III development in second-line NSCLC." To be clear, this was a failed trial (P = 0.217), the results were not compelling and the "improvement" in median overall survival was orders of magnitude away from achieving statistical significance. This was, in part, due to the inclusion of a 1 mg/kg dose arm which reduced the size of each arm to 40 patients. Given that there was a significant volume of data available for docetaxel in combination with 3mg/kg of bavituximab at the time this study was initiated, there was no apparent reason to include the 1mg/kg arm.