Avid Bioservices Inc (CDMO)

[nuke661]

FTM, entdoc: Recapitulation
Thought I’d enter these names in the first line in hopes of getting FTM and/or entdoc to read.

I’ve been fixated on the “teaser” subject matter discussed in the cc started by Joe Pantginis.

It all revolves around how to assess the teaser discussion for interpreting how well the human liver cancer clinical trial headed by Dr. Yopp is performing, along with what new information is being provided on the Bavituximab/ sorafenib combo MOA.

Joe started the subject off by asking , “Okay that’s fair and then with regard to I know Joe mentioned maybe at SITC we would be seeing some translational data from the liver cancer studies, so I was just wondering if there is any potential teaser there…”.

Steve started the response string on this subject with “As far as the you know kind of a teaser, I think we've said right from the beginning that one of the things we've been looking for out of the number of the Investigator-Sponsored Trials are really the correlative data that goes along with the animal studies we've completed showing the – basically the symptom you know the symptomatic changes in the profile of the immune cells that are present in the tumor microenvironment and more broadly in the animals themselves, so that’s kind of data in general that of course we’re looking to present. I’ll let Jeff or Joe add a little bit to that.”

So Steve K kicks it over to the more involved science guy Jeff Hutchins to see how well Jeff can do the cc call dance. Jeff continues the PPHM response with “Yes, as Joe said really the teasers that we are seeing some consistency between what we first identified in the animal models as this increase in CD8 positive T-cells translating quite nicely with these liver samples (the liver samples from the human clinical trials analyzed I assume by PPHM or their agents –Nuke661 comment). Joe you want to comment for that.”

It now appears to me that Jeff is wondering how much he should be saying on this subject and wants to punt it up to Joe Shan’s pay grade and let him get in trouble for saying too much.
Joe’s response is the one that is most intriguing to me.

He says “Yes, I think the totality of the immune changes - of course the CD8 changes are interesting (Nuke again- now the CD8 changes are only “interesting” not really the big deal it seems) - but you know WE BASICALLY ARE RECAPITULATING ALL of the pre-clinical steps within the immune system changes within the tumor. So it’s more than just CD4, CD8, Treg for example there is a lot of information on it will be sharing.”

From my perspective, based on these exchanges, we should be looking at what has been published by Peregrine regarding the pre-clinical trials and should expect the human clinical trials to produce similar results. Here is a CJ post on the pre-clinical trial results from April (as always we can count on CJ for the majority of the wealth of technical information we have readily available to us for real due diligence): Pre Clinical Bavi/Sorafanib PR

The pre-clinical bavi+sorafanib yielded 69% tumor reduction over sorafanib alone. I would think that with human trials having the same immune system changes (“we basically are RECAPITULATING ALL of the pre-clinical steps”; remember that statement was made in regards to the analysis of the liver samples from the human trials) then why shouldn’t we also expect a significant improvement in tumor growth in the human trials.

FTM and entdoc would you please provide an opinion on this assessment of the meaning of “recapitulating all” of the pre-clinical steps. Would this include tumor growth data or just the immune system changes?

I’m not sure how we should interpret the pre-clinical data of “less tumor growth”.

To me this means the tumor grows less rapidly but does not necessarily mean that it reduces the size of an existing tumor. I know that ORR is based on reduction of existing tumor volumes/sizes and ORR is a big surrogate endpoint for accelerated approval for NSCLC (FDA Doc on NSCLC Endpoints ; but where does “reduction of tumor growth fit in” in the big scheme of things?

I would appreciate some of the knowledgeable medical people on this board provide some guidance in how to interpret the “less tumor growth” term used by Peregrine in the pre-clinical trial PR in the link provided above.

To me it certainly looks like they want the world to tune in for the information they intend to present at SITC regarding MOA and data from a Bavituximab/sorafanib combo treatment in humans. They are drawing a lot of attention to the November SITC so they must want people to hear it.

IMO they are using very encouraging words describing what they are seeing for the liver trials; multiple times providing positive descriptions on the same trial that I haven’t heard since the phase 2 NSCLC trial statements prior to the retraction in 9/12. They have been so subdued since 9/12 regarding human trial data that it’s got me wondering what’s coming. And for the persistent naysayers, before you have a chance to say it, I feel pretty confident that it isn’t a train’s headlight either.