Biothera Pharmaceuticals Announces Presentation of Clinical Data Supporting Use of a Patient Selection Biomarker for its Phase 2 Cancer Immunotherapy

Clinical findings presented at the ASCO-SITC Clinical Immuno-Oncology Symposium

EAGAN, MN — February 24, 2017 — Biothera Pharmaceuticals, Inc. will present data today from all cohorts (total N=36) enrolled in a healthy human volunteer study of Imprime PGG, the Company’s phase 2 cancer immunotherapy. The findings showed that administration of Imprime PGG to healthy human subjects results in immunopharmacodynamic (IPD) responses previously associated with the anti-tumor responses in ex vivo human and in vivo mouse studies. This is the first clinical study to show that Imprime PGG responsiveness is dependent upon the formation of an immune complex between Imprime PGG and endogenous anti-beta glucan antibodies (ABA). The results were delivered in a poster presentation at the American Society of Clinical Oncology (ASCO) – Society for Immunotherapy of Cancer (SITC) Clinical Immuno-Oncology Symposium being held from February 23 – 25, 2017 in Orlando, FL.

“Our pre-clinical data in human donor blood had suggested the importance of ABA levels for Imprime-based innate immune activation. Before proceeding to further phase 2 studies, we wanted to explore the relationship between pre-treatment ABA levels and response to Imprime PGG,” said Jeremy R. Graff, Ph.D., Chief Scientific Officer and Senior Vice President, Research at Biothera Pharmaceuticals. “These data now support the use of ABA levels as a pre-treatment biomarker to select patients most likely to respond to Imprime PGG-based therapy for our phase 2 studies.” The Company is 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 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. Pre-treatment ABA levels will be used to pre-select patients for inclusion in these trials.

The Biothera Pharmaceuticals poster, Imprime PGG Drives Innate Immune Activating Pharmacodynamic Changes in a Phase I Clinical Study in Healthy Human Volunteers (Abstract 33, #D6), will be presented today between 11:30 am-1:00 pm and 5:30 pm-6:30 pm on Board D6 in Poster Session B.

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 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
SVP Communications
Biothera Pharmaceuticals, Inc.
651-256-4606
dwalsh@biothera.com

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