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Biothera Pharmaceuticals Initiates Patient Dosing in Phase 2 Trial Investigating Imprime PGG and Merck’s KEYTRUDA® (pembrolizumab)

Study to combine therapies in patients with either advanced melanoma or metastatic triple negative breast cancer (TNBC)

EAGAN, MN — February 23, 2017 — 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 patient 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-β-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.
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 or 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 non-small cell lung cancer (NSCLC), colorectal cancer, and chronic lymphocytic leukemia. In addition to the current trial in advanced melanoma and TNBC, Biothera and Merck are collaborating on a Phase 2 study combining Imprime PGG and KEYTRUDA in head and neck cancer. The two Companies are also collaborating with the Big Ten Cancer Research Consortium, which is recruiting patients for a Phase 1b/2 study investigating the same therapeutic combination in NSCLC.

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

David Walsh
SVP Communications
Biothera Pharmaceuticals, Inc.



David Walsh

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