Biothera Pharmaceuticals Commences Phase 2 Head and Neck Cancer Study Evaluating Combination of Imprime PGG and Merck’s KEYTRUDA® (pembrolizumab)

EAGAN, Minn., Feb. 06, 2018 -- Biothera Pharmaceuticals, Inc. announced today that patient treatment has commenced in its Phase 2 clinical study in squamous cell carcinoma of the head and neck (SCCHN).  The research collaboration with Merck (known as MSD outside the United States and Canada) will evaluate Biothera’s Imprime PGG in combination with KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy, in second- and third-line patients with SCCHN.  

The study will test the potential of combining an innate immune modulator with a targeted adaptive immune system therapy to shrink tumors.  Imprime PGG is an investigational PAMP (Pathogen Associated Molecular Pattern) that activates a cascade of innate immune system responses that culminate in T cell activation and cancer cell killing.  KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.  Preclinical studies show the therapeutic synergy of combining Imprime PGG and immune checkpoint inhibitor antibodies.

The multicenter, open-label Phase 2 study is enrolling 87 patients with advanced SCCHN into two cohorts with distinct patient populations.  One cohort (n=38) will include patients with progressive disease following prior treatment with an immune checkpoint inhibitor.  A second cohort (n=49) will include patients with stable disease following three months or more of KEYTRUDA monotherapy. The primary study endpoints are safety and overall response rate.  Secondary endpoints include progression-free survival and overall survival.  Investigation of tumor biopsies post-Imprime treatment will be conducted to assess changes to immune activity in the tumor microenvironment.  A patient selection biomarker for Imprime PGG is being used to screen prospective study subjects for inclusion into this trial.  More information about the clinical trial is available at www.clinicaltrials.gov, trial identifier: NCT03246685.

About Biothera Pharmaceuticals, Inc.
Biothera Pharmaceuticals is a privately held clinical stage immuno-oncology company developing Imprime PGG, a Phase 2 cancer immunotherapy that has been shown in preclinical studies to enhance the efficacy of anti-cancer immune responses in combination with immune checkpoint inhibitor, tumor-targeting and anti-angiogenic antibodies.  Biothera Pharmaceuticals has clinical research agreements with Merck to evaluate Imprime PGG and KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy, 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.  In addition, Biothera Pharmaceuticals has a clinical collaboration agreement with Genentech to study Imprime PGG in combination with Tecentriq^® (atezolizumab) and Avastin^® (bevacizumab) in metastatic colorectal cancer.

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

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