Avid Bioservices Inc (CDMO)

[Protector]

Couch, hard to say. We know this paper was ready in APRIL 2016 so it might have been out in non public ways. We also have some other documents and a PR on the topic of future trials.

Anybody have any info on when the "planned studies" are to move forward???

AND am I to assume a study in less than a phase trial???

This is all we know.

All proposals must be submitted electronically using the directions below and are due by 5:00 PM (EDT) on June 23, 2016. No exceptions will be granted.

That is TODAY. PPHM probably wanted the info/proposals to pick and announce them before or at the next Q/CC in July.

But in all honesty trying to answer your above questions related to the start date of the trials would be pure guessing because the different source are not even in line.

In the PPHM PR we read no more PII/PIII trials, here we are reading about PI/PII trials. On the web-site it says trials in re-design or something like that and in the more recent ASCO 2016 text it says enrolling (by calculation since somewhere in FEB). On clinicaltrial.gov it show the trial is active but not enrolling yet. So really, using that info to try to say something that would even be an educated guess would be high lottery grade.

The thing of consistence that I did find is:

Specific exclusions from this RFP include:
• Phase 3 studies;
• Studies in pediatric populations;
• Studies in unselected immunotherapy-naïve patient populations where immunotherapy is already approved (NSCLC, renal cancer, bladder cancer, melanoma);
• Combination studies with chemotherapeutic agents;
• Single agent studies, unless the study is a proposed window study evaluating mechanistic endpoints utilizing multiple tumor biopsies;
• Studies evaluating bavituximab in combination with pembrolizumab in hepatocellular carcinoma;
• Proposals focusing solely on preclinical studies.

No studies will utilize doses outside the range for which safety data is available (i.e., nothing greater than bavituximab 3 mg/kg per week) or a mode of administration other than intravenous.

This clearly confirms this is all about Immuno-Therapy and NO CHEMO in the mix (also not as a 3rd component). It also EXCLUDES pre-clinical, hence all proposals must be about human tests. And of course it excludes the pembrolizumab (Merck) clinical trial because that one is already accepted as we saw earlier.

Unfortunately it doesn't say what Durvalumab clinical trials for solid cancers have been excluded otherwise we could know what the solid tumour clinical with AstraZeneca (Durva+Bavi) would be. Anyways