EAGAN, Minn.--(BUSINESS WIRE)--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 PGG 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:
- Imprime PGG, a novel Pathogen Associated Molecular Pattern (PAMP) treatment elicits M1-like transcriptional profile from bone marrow-derived macrophages and tumor associated macrophages (TAMs). Poster #391 will be presented from 12:15-1:30pm EST on Friday, November 11 in the Prince George’s Exhibition Hall AB.
- Imprime PGG, a soluble yeast β-glucan, is a systemically administered PAMP that activates DCs and supports T cell priming, showing synergy with cancer immunotherapies. Poster #179 will be presented from 12:15-1:30pm EST on Friday, November 11 in the Prince George’s Exhibition Hall AB.
- Immune profiling via multiplexed immunofluorescence shows that Imprime based anti-cancer efficacy involves profound changes in macrophage polarization, type 1 IFN signaling and the formation of immune cell clusters (abstract only). Late-breaking poster #468 will be presented from 11:45am-1:00pm EST on Saturday, November 12 in the Prince George’s Exhibition Hall AB.
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.
