Harbour BioMed signed an exclusive strategic partnership deal with Sichuan Kelun-Biotech Biopharmaceutical Co. to develop and commercialize an anti-PD-L1 antibody, A167, currently in Phase II development.
Harbour BioMed signed an exclusive strategic partnership deal with Sichuan Kelun-Biotech Biopharmaceutical Co. to develop and commercialize an anti-PD-L1 antibody, A167, currently in Phase II development.
Under the terms of the deal, the two companies will work to develop combination therapies of A167 with other drugs in their respective territories. The development deal is for commercialization outside of the Greater China region.
Harbour BioMed is paying Kelun-Biotech an undisclosed upfront payment, along with development, regulatory and commercial milestone payments. They have a potential value of more than $350 million. There are also royalties based on annual net sales.
Harbour will maintain the exclusive rights to develop, manufacture and commercialize the compound outside Greater China. The companies will share data created from their own research and clinical trials.
A167 is an immuno-oncology antibody developed by Kelun-Biotech. The antibody binds to immune checkpoint protein PD-L1 and reactivates T-cells against cancer cells. It is currently in several Phase I and Phase II clinical trials in China for lymphoma and solid tumors.
“Anti-PD-L1 therapy has been validated in many clinical trials in the Immuno-Oncology area,” said Jingsong Wang, Harbour BioMed’s founder, chairman and chief executive officer, in a statement. “A167 has significant potential as a single agent and as the foundation for combination therapy with other innovative drugs. We are delighted to advance A167 globally and work closely with Kelun-Biotech to achieve its therapeutic potential. We plan to conduct A167-based combination trials globally by ourselves, including with innovative compounds we are developing, or in collaboration with our partners, to find better therapeutic options against a wide range of tumor types.”
Sichuan Kelun-Biotech Biopharmaceutical Co. is based in Chengdu, China. It is a subsidiary of Kelun Pharmaceutical Group.
Harbour BioMed is based in Shanghai, China and Newton, Massachusetts.
Data analytics company PharmCube, which tracks the Chinese biopharma industry, lists A167 as one of 22 PD-1/L1 checkpoint inhibitors being developed in China. The Cancer Research Institute estimates there are 1,502 clinical trials worldwide in clinical trials utilizing 164 PD-1/L1 compounds as of December 2017.
The checkpoint inhibitor market is currently dominated by Merck and Bristol-Myers Squibb, but the enormous efforts in the market suggest they won’t be the only companies for long.
On August 7, Harbour BioMed signed a deal with Glenmark Pharmaceuticals for the Greater China territory to develop, manufacture and commercialize GBR 1302, Glenmark’s antibody targeting HER2 and CD3 for treating HER2-positive cancers, typically breast cancer and ovarian cancer, although it is expressed in other cancer types as well. Harbour is paying Glenmark an upfront fee and various milestone payments in addition to tiered royalties. The deal could be more than $120 million. Harbour BioMed will head clinical development and commercialization with an option to manufacture GBR 1302 in the Greater China market.
Glenmark has offices in Mahwah and Paramus, New Jersey and in Toronto, Ontario.
Tongtong Xue, chief executive officer of Kelun-Biotech, said in a statement, “A167 is one of the important compounds in our portfolio. We are glad to enter this collaboration with Harbour BioMed which is based on trust in our partner’s capabilities and expertise. The Harbour team brings extensive global clinical development experience that will accelerate clinical trials with A167, especially in the area of combinational therapies. We entered a strategic partnership with Harbour to co-discover, co-develop and commercialize antibodies against innovative targets, based on Harbour’s leading fully human antibody discovery platforms. We have made significant progress in our joint discovery programs against multiple targets in oncology and immunological diseases.”