BeiGene Presents Updated Clinical Data On PD-1 Antibody BGB-A317 In Patients With Advanced Solid Tumors At The Society For Immunotherapy Of Cancer 31st Annual Meeting

WALTHAM, Mass., Nov. 11, 2016 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today presented updated clinical data from an ongoing Phase I study of anti-PD-1 antibody BGB-A317 in patients with advanced solid tumors in a poster presentation at the Society for Immunotherapy of Cancer (SITC) 31 st Annual Meeting held in National Harbor, Maryland. BGB-A317 is an investigational humanized monoclonal antibody against the immune checkpoint inhibitor PD-1. The updated clinical data suggest that BGB-A317 is well-tolerated with anti-tumor activity observed across multiple tumor types.

"We continue to see promising anti-tumor activity with BGB-A317 and a safety profile that is consistent with this class of molecules," said Jayesh Desai, MD, FRACP, a medical oncologist at The Royal Melbourne Hospital and Peter MacCallum Cancer Centre in Melbourne, Australia, coordinating principal investigator of the study.

"The anti-tumor activity from single-agent BGB-A317 is encouraging—to date, we have observed 15 confirmed responses in a variety of solid tumors. We anticipate sharing data from our Phase Ib combination trials with BGB-3111, our BTK inhibitor, and with BGB-290, our PARP inhibitor, in 2017," commented Amy Peterson, MD, Chief Medical Officer, Immuno-oncology at BeiGene.

Summary of Results from an Ongoing Phase 1 Study

The multi-center, open-label Phase I trial of BGB-A317 is being conducted in Australia and New Zealand to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of BGB-A317 in patients with advanced solid tumors. As of August 15, 2016, 103 patients were treated with BGB-A317 as a monotherapy. 22 patients were treated across four dose escalation cohorts with biweekly (Q2W) intravenous doses ranging from 0.5 to 10 mg/kg, and 81 patients were treated across four schedule expansion cohorts, receiving 2 or 5 mg/kg intravenously either Q2W or once every three weeks (Q3W). A single dose-limiting toxicity (DLT) of grade 3 colitis was observed in the 5 mg/kg Q2W dose escalation cohort containing six patients; a maximum tolerated dose was not reached. The study is currently evaluating flat dosing of 200 and 300 mg Q3W and further exploring BGB-A317 activity in multiple tumor types in the Phase 1b part of the study.

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