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Biothera Pharmaceuticals Initiates Patient Dosing in Phase 2 Trial Investigating Imprime PGG and Merck's KEYTRUDA® (pembrolizumab)EAGAN, Minn., Feb. 23, 2017 (GLOBE NEWSWIRE) -- Biothera Pharmaceuticals, Inc. today announced that dosing has been initiated in a Phase 2 clinical trial evaluating Biothera’s Imprime PGG in combination with the Merck (known as MSD outside the United States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with either advanced melanoma who have progressed on treatment with a checkpoint inhibitor therapy, or with TNBC whose disease has progressed following treatment with one or more lines of therapy for metastatic disease. The multi-center, open-label study is anticipated to enroll up to 71 patients. Imprime PGG is an investigational PAMP (Pathogen Associated Molecular Pattern) drug that acts therapeutically as an immunological “ignition switch” to activate multiple innate immune functions that drive a coordinated anti-cancer immune attack in combination with immune checkpoint inhibitors. “The ability of Imprime PGG to enhance antigen presentation to T cells and shift the immune microenvironment of the tumor from suppressive to permissive may substantially improve patint responses to checkpoint inhibitor therapy,” said Bruno Osterwalder, M.D., Biothera Pharmaceuticals’ Chief Medical Advisor. The primary endpoint of the Phase 2 study is overall response rate (ORR). The secondary endpoints include overall survival (OS), progression-free survival (PFS), and safety. The study will also evaluate pharmacodynamic markers that can further elucidate the anti-cancer immune activity associated with Imprime PGG. Patients will be selected for the trial using a mechanism-based, predictive biomarker (IgG anti-ß-glucan antibody, or ABA), and the data from the trial will help refine the use of the biomarker for future combination studies. Biothera Pharmaceuticals will conduct the Phase 2 study, under a previously announced collaboration with Merck. About Biothera Pharmaceuticals, Inc. 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 [email protected] |