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Biothera Pharmaceuticals Announces Presentation of Clinical Data Supporting Use of a Patient Selection Biomarker for its Phase 2 Cancer ImmunotherapyEAGAN, Minn., Feb. 24, 2017 (GLOBE NEWSWIRE) -- 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 headand 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, Effect of Imprime PGG on Innate Immune-Activating Pharmacodynamic Changes in a Phase I Clinical Study in Healthy Human Volunteers (Abstract 33), 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. 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 [email protected] |