Biothera Pharmaceuticals’ Phase 2 Study of Imprime PGG Combination Therapy in Non-Small Cell Lung Cancer Patients Published in Investigational New Drugs

EAGAN, MN — March 24, 2017 — Biothera Pharmaceuticals, Inc. today announced peer-reviewed publication of results of a randomized Phase 2 clinical study of the Company’s cancer immunotherapy Imprime PGG in combination with Erbitux® (cetuximab) and chemotherapy in metastatic non-small cell lung cancer (NSCLC) patients. The study findings have been published online in the journal Investigational New Drugs.

Completed by Biothera in 2013, the study was part of an early series of clinical trials combining Imprime PGG with tumor-targeting monoclonal antibodies. The Company is now focusing its clinical development program on Imprime PGG combinations with checkpoint inhibitor therapies in multiple cancer indications. The results of the NSCLC study, along with other positive findings from early studies, suggest increased probability of success in further clinical development of Imprime PGG.

As reported in Investigational New Drugs, the 90-patient study demonstrated signals of efficacy for the Imprime PGG combination therapy. Imprime PGG was well tolerated, with adverse events expected of the backbone therapy predominating.  Further, a retrospective analysis of the study suggests that the subset of patients with sufficient levels of anti-beta glucan antibody, a natural occurring biomarker for Imprime PGG, may achieve improved clinical outcomes.

“These results provide an important demonstration of the clinical activity of Imprime PGG, which has been administrated to more than 350 patients in multiple cancer indications,” said Bruno Osterwalder, M.D., Chief Medical Advisor to Biothera Pharmaceuticals. “The study also provides early evidence of a biomarker for identifying patients in future studies who may best respond to Imprime PGG combination therapies.”

Biothera is currently conducting a Phase 2 clinical study to evaluate Imprime PGG in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with either advanced melanoma or metastatic triple negative breast cancer. Biothera will also test this therapeutic combination in a Phase 2 head and neck cancer study, in collaboration with Merck, that is expected to begin in the third quarter of 2017. An additional study in collaboration with Big Ten Cancer Research Consortium will test this combination in a Phase 1b/2 study in NSCLC patients.

The citation for the paper in Investigational New Drugs is Thomas, M., Sadjadian, P., Kollmeier, J. et al. Invest New Drugs (2017). doi:10.1007/s10637-017-0450-3.

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. Imprime PGG has been well-tolerated and has established proof of concept in trials with more than 400 subjects.

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

Contact:
David Walsh
Communications
Biothera Pharmaceuticals, Inc.
651-256-4606
dwalsh@biothera.com

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