Avid Bioservices Inc (CDMO)

[Fire Fox]

Rocking Jack- Your post sounds like my discussion yesterday with Jay Carlson. Some of the PC patients were so sick they died before Bavi’s immune stimulatory effects could develop. That’s why the subset analysis is likely to be more encouraging.

Jay pointed out that the other immuno-therapeutic MAbs like PD-1 and Ipilimumab also require multiple doses over extended time before the immuno-therapeutic benefits show up. Apparently, Ipilimumab was almost abandoned until they realized it needed to be given to healthier patients over a longer period of time.

Also note that the ECOG status of patients in the Fulfironox and Abraxane trials included only 0 and 1 patients, whereas the Bavi PC patients had ECOG status of 0, 1 and 2. If you look up the criteria for ECOG 2, you will see it means being MUCH sicker than ECOG 1.

Also, the Bavi trial included patients with metastatic PC.

The Company views the Phase II pancreatic trial as a signal seeking trial. My interpretation of what I heard (i.e. connecting dots) is that the data revealed a strong signal, especially in subsets that stayed alive long enough to receive multiple doses.
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IMHO, and not based on anything I heard, I speculate that the subset analysis will be for only those patients with ECOG status 0 and 1. This would make for a good comparison with Abraxane and Fulfironox. The sample size would be small, but it could make for a juicy tidbit at ASCO.