BeiGene Enrolls First Patient in Phase I Study of BGB-A317, A Humanized Anti-PD-1 Monoclonal Antibody

20:00 EDT 4 Jun 2015 | Globe Newswire

– PD-1 monoclonal antibody will be tested in first-in-human Phase I dose escalation and expansion cohorts in advanced malignancies to establish single-agent properties and preliminary anti-tumor activity –

– Fourth oncology candidate to enter clinic in last 18 months –

BEIJING, June 5, 2015 (GLOBE NEWSWIRE) -- BeiGene Ltd., an innovative oncology company focused on developing targeted and immune-oncology therapeutics, today announced that it has dosed the first patient in a Phase I study of BGB-A317 for the treatment of advanced cancer. BGB-A317 is a highly selective and potent, humanized anti-PD-1 monoclonal antibody. PD-1 plays an important role in immune modulation of tumor progression by regulating the key inhibitory signaling in the T-cells when engaged by its ligands.

"We have continued to rapidly accelerate our research and development plan, with four promising candidates against different targets entering the clinic within the past 18 months," commented John V. Oyler, CEO of BeiGene. "As our fourth program to enter clinical studies, BGB-A317 is yet another validation of our novel translational research platform and a reflection of our ability to execute on significant clinical milestones. We look forward to advancing our additional promising preclinical candidates in the months ahead."

In addition to BGB-A317, three other small molecular inhibitors: BGB-3111 (BTKi), BGB-283 (BRAFi Dimer-i) and BGB-290 (PARPi), are in Phase I clinical studies.

About the Study

The Phase I multicenter, open-label, dose escalation and expansion clinical trial of BGB-A317 is designed to assess the safety, tolerability and pharmacokinetic properties and antitumor activities of BGB-A317 as a single agent. Key objectives in the study include determining maximum tolerated dose, if any, recommended phase II dose, pharmacokinetics, and preliminary anti-tumor activity of BGB-A317 in a variety of human tumors.

About BeiGene Ltd.

BeiGene is an innovative oncology R&D company focused on discovering, developing and commercializing targeted and immune-oncology therapeutics through a novel translational research platform that combines unique access to internal patient-derived biopsies with strong oncology biology. With a team of 170+ scientists and staff, its pipeline is comprised of novel oral small molecules and monoclonal antibodies for cancer. For more information, please visit our website at

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