Clinical-stage biopharmaceutical company BeiGene has commenced its Phase I clinical trial of BGB-A317 in China to treat advanced solid tumours.
BGB-A317 is a humanised monoclonal antibody belonging to a class of immuno-oncology agents known as immune checkpoint inhibitors.
It specifically fuses with cell surface receptor PD-1, which is considered to play an important role in downregulating the immune system by inhibiting activation of T-cells.
Unlike the currently approved PD-1 antibodies, BGB-A317 can bind with Fc gamma receptor I specifically engineered out.
The Phase I, open-label, multi-centre study of BGB-A317 has been designed to determine the safety, tolerability, preliminary anti-tumour activity and pharmacokinetics profile of BGB-A317 while treating patients with advanced solid tumours in China.
Beigene founder and CEO John Oyler said: “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 US, and Taiwan recently reported at the 2016 Society for Immunotherapy of Cancer 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.”
The trial will be headed by Professor Yilong Wu from Guangdong General Hospital, while Professor Lin Shen and Professor Jun Guo from Beijing Cancer Hospital will serve as the co-lead investigators.