Biothera Pharmaceuticals Preclinical Data Further Validate Mechanism of its Phase 2 Cancer Immunotherapy, Imprime PGG

3 Poster Presentations Scheduled for Society for Immunotherapy of Cancer Annual Meeting

EAGAN, MN — November 11, 2016 — Biothera Pharmaceuticals, Inc. will present new preclinical data today that further validate the ability of its Phase 2 cancer immunotherapy drug Imprime PGG to induce coordinated innate and adaptive immune responses that may enhance the efficacy of checkpoint inhibitor therapies. The data will be highlighted in three poster presentations, including one late-breaking poster, at the annual meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, MD, November 11-13, 2016.

The new findings in several in vivo preclinical models confirm earlier in vitro research that show Imprime PGG administration activates critical cross-talk between the innate immune effector cells and the adaptive immune system, driving cytotoxic T cell expansion and the production of anti-tumor cytokines. The data also show that Imprime PGG “flips” the suppressive immune microenvironment of the tumor to an environment that promotes immune recognition and destruction of the tumor. These effects were associated with changes in biomarkers and immune cell types at the tumor site, as observed using immunohistochemistry and algorithm-based analysis. Biothera will continue to apply this technology in upcoming Phase 2 clinical studies to analyze tumor biopsies for changes in the tumor microenvironment.

“The data presented at SITC further elucidate the ability of Imprime to trigger the changes across the immune system that enable a coordinated, anti-cancer immune response,” said Jeremy Graff, Ph.D., Biothera Pharmaceuticals Chief Scientific Officer and Senior Vice President, Research. “Importantly, we can show now these changes at the tumor site using the same technology to be used in our upcoming clinical trials.”

Imprime PGG is a Pathogen Associated Molecular Patterning (PAMP) molecule that acts therapeutically as an immunological “ignition switch” to activate a number of innate immune functions that then drive a coordinated anti-cancer immune attack in combination with immune checkpoint inhibitors, anti-angiogenic and tumor targeting antibodies. Biothera Pharmaceuticals and Merck are advancing a phase 2 clinical research collaboration to evaluate Imprime PGG and Merck’s anti-PD-1 inhibitor KEYTRUDA® (pembrolizumab) in patients with either advanced melanoma or metastatic triple negative breast cancer. The Companies are also collaborating with the Big Ten Cancer Research Consortium to commence an Imprime PGG plus KEYTRUDA Phase 1b/2 study in patients with non-small cell lung cancer (NSCLC).

Biothera Pharmaceuticals’ SITC poster presentations are as follows:

About Biothera Pharmaceuticals, Inc.
Biothera Pharmaceuticals is a privately held biotechnology company developing Imprime PGG, a mid-clinical stage cancer immunotherapy that orchestrates an integrated anti-cancer immune response in combination with checkpoint inhibitors, as well as tumor-targeting and anti-angiogenesis monoclonal antibodies. Imprime PGG has been well-tolerated in trials in over 400 subjects and has established proof of concept in multiple clinical studies, including single-arm and randomized phase 2 studies in NSCLC, colorectal cancer, and chronic lymphocytic leukemia.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Contact:
David Walsh
SVP Communications
Biothera Pharmaceuticals, Inc.
651-256-4606
dwalsh@biothera.com

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David Walsh

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