BeiGene Gets Approval To Initiate Trials In China With PD-1 Antibody BGB-A317

(RTTNews) - BeiGene Ltd. (BGNE) announced that it has received Clinical Trial Application or CTA approval from the China Food and Drug Administration or CFDA to conduct clinical trials in China with investigational agent BGB-A317, a PD-1 antibody, for the treatment of advanced solid tumors.

China is the fifth territory in which BGB-A317 has received approval to conduct clinical trials, in addition to Australia, New Zealand, the United States, and Taiwan. To date, BGB-A317 has been dosed in more than 200 patients, and preliminary data from the Phase I dose-escalation study of BGB-A317 were presented at the 2016 American Society of Clinical Oncology Annual Meeting in June.

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 it believes 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.