BeiGene Announces First Patient Dosing in China Phase I Trial with Investigational Anti-PD-1 Monoclonal Antibody BGB-A317

On December 30, 2016 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the dosing of the first patient in a Phase I clinical trial of BGB-A317, an anti-PD-1 monoclonal antibody, in mainland Chinese patients with advanced solid tumors (Press release, BeiGene, DEC 30, 2016, View Source [SID1234517240]).

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"We are pleased to report that BGB-A317 is now in Phase I clinical evaluation in mainland China. To date, all four of our clinical-stage molecules are active in the clinic in China. We are enthusiastic about the agent’s therapeutic potential, with promising data from an ongoing Phase I study of BGB-A317 in Australia, New Zealand, the United States, and Taiwan recently reported at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. We are committed to developing BGB-A317 for patients in China, where this exciting class of immuno-oncology agents is still not approved," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.

The Phase I open-label, multi-center study of BGB-A317 is designed to investigate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-A317 in Chinese patients with advanced solid tumors. Professor Yilong Wu from Guangdong General Hospital is the lead principal investigator of the study. The co-lead investigators are Professor Lin Shen and Professor Jun Guo, both of Beijing Cancer Hospital.

About BGB-A317

BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1, and we believe it is differentiated from the currently approved PD-1 antibodies with the ability to bind Fc gamma receptor I specifically engineered out. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.