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PPHM & Memorial Sloan Kettering's Dr. Wolchok

PPHM treated about 19 patients with Ipilimumab (Yervoy/BMS)+Bavituximab in Advanced Melanoma in a clinical trial ran by the University of Texas SW. We don't have the results of that clinical trial yet. The trial was stopped when during the trial the Standard of Care (SOC) changed. However the results are available to PPHM/UTSW because the complete 24 patients sample was scheduled for completion in April 2016.

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It was Dr. Wolchok (BIO) who is an IO and melanoma specialist that ran the PIII for Ipilimumab (Yervoy/BMS).

About Me
I am a medical oncologist who specializes in caring for people with melanoma. As a researcher, I am working to develop innovative ways to use the immune system to treat cancer. I have been at the forefront of cancer immunotherapy as a clinician-scientist and as a principal investigator of several pivotal clinical trials.

One of these was a large phase III trial that led to the FDA approval of ipilimumab (Yervoy®), an antibody now used as a first-line treatment for people with advanced melanoma. Ipilimumab was the first drug ever shown to improve survival in these patients. It has fundamentally changed this disease’s outcome — people who were once given a matter of months are living years longer in some cases. A number of patients I treated with ipilimumab in 2004 are still alive and free of cancer today. As a physician, nothing is more gratifying than being able to give someone his or her life back after cancer.

Despite the successes of ipilimumab, only about 20 percent of melanoma patients respond to the drug. ...

This is Dr. Wolchok's Lab with several people involved in the Labs work related to PPHM's Bavituximab.



Of course Dr. Wolchok himself ...


But also Taha Merghoub,PhD


and Sadna Budhu, PhD


Annual Meeting AACR 2017

It is with that team that PPHM will present 2 of 5 presentations at AACR. Of the 9 presentations Dr. Wolcock is involved with, only one other company, BMY (from Yervoy and Opdivo), is the other one with two presentations.

A more detailed overview by cjgaddy

The WISTAR Question

Last December at the Wistar conference North40000 asked Dr. Wolchok a couple of questions. One of them was the one I suggested:

"Will tumour environment conditioning through Phosphatidylserine targeting become a combination ingredient needed to allow most new immuno-therapy treatments to benefit from an activated immune system and achieve better results or larger responder foot-prints?"

and this was the answer that came back via north40000...

Dr Wolchok answered/opined that the pre-clinical work did support a "yes" answer to that question. By way of introduction, I had directed his attention to the SITC slide above. He went as far as pulling a slide from his power-point presentation that featured a photograph of his laboratory staff and colleagues to identify for us conference attendees who Budhu is.

More later on the Wistar conference in general, and other conversations I had with Dr. Wolchok, both pre-conference as well as post-conference.

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PPHM and PS-Targeting IP

PS-Targeting is covered by patents. PPHM holds the complete set of patents for binding the Phosphotidylserine molecules in a 100% unencumbered way. Most small cap biotechs have their IP largely encumbered by bread-crumb deals with BP and while therefore mostly in better stock-price shape they lost their negotiation power in the process if one they their drug seems to work.

The other PS related IP is binding to the PS-receptors on immune system cells.It are companies like Roche, Novartis, etc that hold that IP scattered and there substances mostly bind one specific PS-receptor while about 10 of them exist.

Dr. Wolchok's Lab work on PS-targeting clearly revolves around PS-molecule targeting, as is the historical and recent work of UTSW (late Dr. Ph. Thorpe's Lab now combined with Dr. Brekken's Lab), and as apparently captured the interest of many other prominent research institutes and our many KOL's (Key Opinion Leaders).

These other's besides Memorial Sloan Kettering such as, Duke, MDA, Rutgers, ImmunoVaccine, UTSW, Moffit, Wistar can be found in more detail in cjgaddy's compilation..

With the support of peer-reviewed papers confirming that PS has a Global/Systemic/Upstream function PS-targeting becomes the technique to condition the tumour environment. PS-targeting, with Bavituximab or in the future with our new patented next generation Betabodies, is becoming the technique that will be used in combination with drugs like anti-PD-1 and anti-CTLA-4 (Opdivo, Yervoy, Keytrude, Durvalumab, ...) to make them work better.

While Dr. Wolchok says that research shows that the IO drug that he worked with only has responses in 20% of the patients, the work of Dr. Brekken's Lab at UTSW has shown, several times now, that PS-targeting can increase these responses dramatically (60-70% range). Brekken's mice all dying from old age, after being re-infected a second time and not being treated the second time, will remain an unseen performance proving Bavituximab can incite lasting immune-response and do away with relapse of the same cancer.

BIOMARKERS

We expect the final results of biomarkers at AACR. The abstract is under embargo but must hold the latest of the latest on this topic because the Sunrise trial has been marked as complete a few days ago.
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With these biomarkers the coming clinical trials, such as the 3 planned with NCCN of which one is to start recruiting patients in about 30 days source will be shortened consistently. Biomarkers allow to target the patients for which PS-Targeting will work (about 60/70% of patients). This means the Median Tables should grow apart VERY VERY rapidly because a biomarker driven arm has so to say pre-selected high responding patients to Bavituximab. PPHM said that iy was involved in the design of the NCCN trials for the biomarker part.

CONCLUSION

The fact that PPHM had a collaboration with Memorial Sloan Kettering was remarkable news on its own afew years ago, because MSK can cherry pick the projects that are the most interesting and bring the most prestige to their researchers. Mostly we saw the big players in those collaborations. The sponsoring by PPHM is of lesser consequence because MSK is very well funded.

MSK and PPHM not only renewed the collaboration this year but as we can see now they are coming out with PPHM. Before Bavituximab or Peregrine Pharmaceuticals would not be mentioned in Wolchok's presentations because reputation is everything in the research world and one needs to be sure, but after Wistar, AACR will change that. Being endorsed by someone like Dr. Wolchok is not nothing and with Dr. Birge (Rutger's), Dr. Antonia (Moffit), Dr. Gabrilovich (Wistar) and of course Dr. Brekken (UTSW), just to name a few PS-Targeting supporters, he is in good company.

PPHM has now 3 horses to run with: Avid, Exosomes and PS-Targeting.

PPHM announced that they would be profitable (now in 14 months). To make such announcement CEO King must be quite sure otherwise this is a fact that can easily be verified and of which one can easily asses if the goal is obtained. I guess that this becoming profitable will be a MAJOR goal for option assignment of the concerned year then!