Celgene Corporation has entered a strategic collaboration with BeiGene to develop and commercialize its PD-1 inhibitor BGB-A317, an immunotherapy primarily aimed at treating solid tumors, in the U.S., Europe, Japan and much of the world, except for Asia.
BGB-A317 is currently in two pivotal trials in China, and BeiGene will retain development and commercialization rights to the therapy for solid tumors in Asia (excepting Japan), while Celgene will have those rights worldwide, except in Asia countries outside of Japan. Global studies of BGB-A317 are planned to being in 2018.
“The acquisition of BGB-A317 significantly accelerates and expands our opportunity to develop and deliver novel T-cell checkpoint inhibitor-based therapies in solid tumor cancers to patients worldwide and adds to our ongoing PD-L1 FUSION program in hematological malignancies,” Mark J. Alles, chief executive officer of Celgene, said in a press release. “China is an important market for Celgene, and our collaboration with BeiGene positions us exceptionally well to optimize research, manufacturing, and the long-term commercial potential of our portfolio in China.”
BGB-A317 is a humanized antibody directed against PD-1. It is called a checkpoint inhibitor because it prevents the PD-1 protein from sending an inhibitory signal to specialized immune cells that react against tumors.
In this case, BGB-A317 is designed to allow the immune system to fight advanced solid tumors. It is different from other PD-1 inhibitors because it has been engineered so that it is not mopped up, and prevented from exerting its effect, by proteins, called Fc gamma receptors, found on the surfaces of other immune cells.
A Phase 1 trial (NCT02407990) of BGB-A317 began in June 2015 and is expected to be finish soon. A pivotal Phase 2 clinical trial for urothelial cancer started in China in 2017. BGB-A317 was conceived to be used as a single therapy, or in combination with other therapies, for solid tumor cancers. Celgene and BeiGene will collaborate on its development globally.
BeiGene will also acquire Celgene’s commercial operations in China and exclusive license to Celgene’s commercial portfolio of cancer drugs in China: Abraxane (paclitaxel), Revlimid (lenalidomide), and Vidaza (azacitidie), and retain global development and commercialization rights to BGB-A317 to treat hematological malignancies.
“This strategic partnership with Celgene is a transformational event for BeiGene, transitioning us into a commercial-stage company and preparing us well for the future potential launch of our internally developed compounds, some of which are already in pivotal trials in China,” said John V. Oyler, co-founder, CEO, and chairman of BeiGene. “Aligned in our mission and therapeutic focus, we believe that we have forged a promising alliance.”
The transaction is expected to be completed in the third quarter of 2017.