BEIJING, Jan. 08, 2016 (GLOBE NEWSWIRE) — BeiGene, Ltd., a clinical-stage biopharmaceutical company focused on developing molecularly-targeted and immuno-oncological drugs for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for the clinical development of BGB-A317, a humanized monoclonal antibody against the immune checkpoint receptor PD-1 and Phase IA/IB studies for BGB-A317 may now proceed in the U.S.
“This is a significant milestone for BeiGene, and also for the wider Chinese biopharmaceutical industry,” said John V. Oyler, Chief Executive Officer of BeiGene. “We are honored to be at the forefront of the expanding global efforts of Chinese drug discovery.”
Wendy Yan, Senior Vice President and Head of Regulatory Affairs additionally commented, “We are delighted to build on the success of our previous U.S. IND, for our small molecule BTK inhibitor BGB-3111, with this IND effective of our first biologic in the United States.”
BeiGene plans to develop BGB-A317 as a monotherapy and as a combination agent with small molecule therapeutics for various solid-organ and blood-borne cancers. The IND will allow BeiGene to include sites in the United States in its ongoing global study for BGB-A317 in patients with relapsed or refractory solid tumors. The trial, which is currently underway in Australia, is an open label, dose-escalation and expansion study to investigate the safety, pharmacokinetics, and antitumor activities of BGB-A317 in patients with advanced tumors. A total of 51 patients had been dosed in the study as of November 30, 2015.
Ruirong Yuan, M.D., Chief Medical Officer and President of BeiGene Global Clinical Research and Development, commented “We believe BGB-A317 is potentially differentiated from currently approved PD-1 antibodies in that its ability to bind the Fc gamma receptor I has been specifically engineered out, and we believe this could potentially lead to improved activities. In addition, BGB-A317 has unique binding characteristics to PD-1, and may have superior target specificity.”
About BGB-A317
BGB-A317 is a humanized monoclonal antibody that belongs to a promising new 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 is believed to be differentiated from the currently approved PD-1 antibodies with the ability to bind Fc gamma receptor I specifically engineered out, and has the potential to restore a T-cell’s cancer killing ability by inhibiting PD-1 and removing the blockade of immune activation against cancer.
About BeiGene
BeiGene is a global, clinical-stage, research-based biotechnology company focused on targeted and immuno-oncological therapeutics. With a team of 215+ scientists and staff, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions aimed to have both a meaningful and a lasting impact on cancer patients. For more information, please visit our website at www.beigene.com.
CONTACT: Media/Investor Contact: Xin Huang US: +1 917-617-4653 China: +86 185-1406-3050 pr@beigene.com
