Avid Bioservices Inc (CDMO)

[biopharm]

Dmitry Gabrilovich : Peregrine Pharmaceuticals KOL :

Phase II Clinical Data Presented at SITC Annual Meeting Support Immunotherapeutic Mechanism of Action of Peregrine Pharmaceuticals' Bavituximab in Liver Cancer

Nov 10, 2014

TUSTIN, CA, Nov 10, 2014 (Marketwired via COMTEX) -- Peregrine Pharmaceuticals, Inc. PPHM, -4.52% PPHMP, -0.21% today announced the presentation of clinical and preclinical data related to the company's immuno-oncology development program and its lead investigational immunotherapy drug candidate bavituximab at the Society for Immunotherapy of Cancer's (SITC) 29th Annual Meeting and Associated Programs. This conference was held November 6-9, 2014 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland. The translational clinical presentation titled: "Correlative Studies of a Phase II Clinical Study of Bavituximab and Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)" was presented Saturday.

"The correlative studies from these liver cancer patients provide further support for the hypothesis that bavituximab can positively regulate immune cells in tumors and thus may provide a new and exciting possibility for therapeutic manipulation of the tumor microenvironment," said Dimitry I. Gabrilovich, M.D., Ph.D., a collaborator on the studies and a Christopher M. Davis Professor in Cancer Research and Program Leader, Translational Tumor Immunology at The Wistar Institute in Philadelphia, Pennsylvania.

Data from this translational sub-study consisting of six patients show that half of the patients evaluated had an increase in tumor fighting immune cells following one cycle of treatment, similar to what has been shown for PS-targeting antibodies in multiple preclinical cancer models. In addition, the increase in immune response was associated with patients that remained on study treatment for longer time periods, suggesting the possibility of a clinically meaningful anti-tumor immune response. Three of the six patients evaluated had increased infiltration of CD8 T-cells into the tumor microenvironment which correlated with a prolonged time to disease progression. In addition, these responding patients expressed lower levels of PD-1, an established marker of T cell activation and disease outcome, prior to the initiation of therapy, followed by a measurable rise.

"These translational data align very well with previous preclinical data that define bavituximab's immunotherapy-based mechanism of action and show that the combination of bavituximab and sorafenib can potentiate an anti-tumor response in patients with advanced HCC," said Nikoletta Lea Kallinteris, M.Sc., CCRP, senior scientist, translational research at Peregrine Pharmaceuticals. "Another interesting observation is that the increase in PD-1 positive T-cells observed in several patients from this trial provides rationale for the potential of bavituximab to increase the number of subjects who may respond to PD-1 targeted treatments.

Peregrine is actively working to further explore the potential of bavituximab in this and other indications as we look forward to the presentation of full clinical outcome data from this Phase II clinical trial by its lead investigator, Adam Yopp, M.D., assistant professor of surgery at the University of Texas Southwestern Medical Center in Dallas, Texas at a future medical conference.

http://www.marketwatch.com/story/phase-ii-clinical-data-presented-at-sitc-annual-meeting-support-immunotherapeutic-mechanism-of-action-of-peregrine-pharmaceuticals-bavituximab-in-liver-cancer-2014-11-10?siteid=bigcharts&dist=bigcharts

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The red bold above is what you call preparing the FDA for surrogate endpoints that equate to overall survival. Looks like the (DMC) Data Monitoring Committee will be picking up some new knowledge that they must use on any trials they may be involved in and remember, surrogate endpoints are the hot topic running thru the FDA at this time and the more that the MOA of Bavi/PS Targeting comes to light, the faster the FDA approvals will be coming for PS Targeting combo treatments. When shall the FDA approve surrogate endpoints related to PS Targeting ?... I'd say around the time frame that Adam Yopp explains the full clinical outcome data from the IST liver trial

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