Biothera Pharmaceuticals Announces Initiation of Phase 1b/2 Clinical Study Evaluating Combination of Imprime PGG and Merck’s KEYTRUDA in Non-Small Cell Lung Cancer

EAGAN, Minn., July 19, 2017 -- Biothera Pharmaceuticals, Inc. today announced that the Big Ten Cancer Research Consortium has begun patient dosing in a Phase 1b/2 clinical study to evaluate Biothera’s Imprime PGG in combination with the Merck anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in second-line non-small cell lung cancer (NSCLC).  The University of Illinois at Chicago is the first of five Big Ten study sites to initiate patient enrollment.  Merck (known as MSD outside the United States and Canada) is providing funding and clinical supplies of KEYTRUDA for the study.

The goal of the Phase 1b/2 study will be to determine the potential of Imprime PGG, an investigational PAMP (Pathogen Associated Molecular Pattern) drug, to increase patient responses to KEYTRUDA, a humanized monoclonal antibody that works as an immune checkpoint inhibitor to activate the anti-tumor killing functions of cytotoxic T cells.  Imprime PGG acts as an immunological “ignition switch” that triggers a cascade of activating events throughout the innate immune system that culminate in T cell activation and cancer cell killing.  In preclinical studies, Imprime PGG has been shown to enhance the efficacy of immune checkpoint inhibitor antibodies.

“While we have seen great advances in the field of cancer immunotherapy, we want to address the significant continuing need among patients, including those with refractory disease,” said Lawrence E. Feldman, M.D., principal investigator of the NSCLC study at the UI Health Cancer Center. “This new trial brings together a promising combination approach that we believe may increase patient responses to KEYTRUDA and ultimately improve the lives of patients with non-small cell lung cancer.”

The multi-center Phase 1b/2 study is a single-arm trial expected to enroll up to 36 patients with metastatic NSCLC whose cancer worsened during or after treatment with platinum-based chemotherapy. The phase 1b portion of the trial is a dose-escalation study of up to 12 patients receiving Imprime PGG in combination with KEYTRUDA. The phase 2 portion will measure median progression-free survival and overall survival in up to 24 subjects receiving the combination therapy. More information about the clinical trial is available at www.clinicaltrials.gov, NCT identifier NCT03003468.

“Our extensive translational research indicates there is a significant opportunity for the combination of Imprime PGG and KEYTRUDA to benefit second-line patients with non-small cell lung cancer,” said Bruno Osterwalder, M.D., Biothera Pharmaceuticals’ Chief Medical Advisor. “We are very pleased to be working with the Big Ten Cancer Research Consortium and Merck on this study.”

About the Big Ten Cancer Research Consortium
The Big Ten Cancer Research Consortium creates a unique team-research culture to drive science rapidly from ideas to treatment-changing paradigms. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer. Together, Big Ten cancer centers support the work of 2,600 cancer researchers, care for more than 50,000 new cancer patients each year, and enroll 20,000 patient volunteers on cancer clinical trials.

About Biothera Pharmaceuticals, Inc.
Biothera Pharmaceuticals is a privately held biotechnology company developing Imprime PGG, a Phase 2 cancer immunotherapy that enhances the efficacy of anti-cancer immune response in combination with immune checkpoint inhibitor, tumor-targeting and anti-angiogenesis antibodies.  Biothera Pharmaceuticals has clinical research agreements with Merck to evaluate Imprime PGG and KEYTRUDA in Phase 2 studies in advanced melanoma, metastatic triple negative breast cancer, and head and neck squamous cell cancer. This therapeutic combination also is the focus of a Big Ten Cancer Research Consortium Phase 1b/2 trial in patients with non-small cell lung cancer. Imprime PGG has demonstrated a favorable safety profile in more than 400 subjects and signals of activity in multiple combinations and tumor types.

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

Contact:
David Walsh
Biothera Pharmaceuticals, Inc.
651-256-4606
[email protected]