Harbour BioMed will partner with Sichuan Kelun-Biotech Biopharmaceutical to develop and commercialize its Phase II cancer immunotherapy candidate A167 worldwide except greater China, through an exclusive collaboration that could generate more than $350 million for Kelun-Biotech, the companies said today.
A167 (formerly KL-A167) is an anti-programmed death-ligand 1 (PD-L1) antibody currently in multiple Phase I and Phase II trials in China targeting lymphoma and solid tumors.
A167 is designed to bind to immune checkpoint protein PD-L1, and reactivate T cells in the body against cancer cells. The antibody is envisioned for use in a broad range of solid tumor and hematological malignancies.
Among them is relapsed or refractory classical Hodgkin lymphoma, in which Kelun-Biotech plans to recruit an estimated 104 participants for an open, multicenter Phase II trial (NCT03580564), with the efficacy of A167 to be measured by Overall Response Rate (ORR). The study’s estimated primary completion date is February 28, 2021, according to ClinicalTrials.gov.
Harbour BioMed and Kelun-Biotech said they agreed to share data from their own research and clinical trials to support monotherapies and combination therapies of A167 with other agents for both parties’ development and registration.
“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,” Jingsong Wang, M.D., Ph.D., Harbour BioMed’s founder, chairman and CEO, said in a statement.
Harbour BioMed agreed to pay Kelun-Biotech upfront payments, as well as payments tied to achieving development, regulatory, and commercial milestones, with a potential total of more than $350 million. Kelun-Biotech is also eligible for royalty payments from Harbour BioMed based on a percentage of annual net sales.
Harbour BioMed will have exclusive rights to develop, manufacture and commercialize A167 in regions outside of Greater China.
The collaboration is Harbour Biomed’s second with Kelun-Biotech to be launched this year. The first was initiated when the companies agreed to co-discover, co-develop, and commercialize antibodies against innovative targets, based on Harbour’s fully human antibody discovery platforms.
“We have made significant progress in our joint discovery programs against multiple targets in oncology and immunological diseases,” Xelun-Biotech CEO Tongtong Xue, Ph.D., added.
Xelun-Biotech is a subsidiary of Kelun Pharmaceutical Group focused focusing on developing small molecules, biologics, and cell therapies for cancer as well as hepatitis B virus, metabolic diseases, autoimmune diseases, anesthesia, and pain. With headquarters in Chengdu, China, and U.S. operations in Cranbury, NJ, Xelun-Biotech currently has over 20 biologics and over 30 innovative small molecule programs, including five biologics and four innovative small molecule programs in clinical trials.
Harbour BioMed develops immuno-oncology and inflammatory disease treatments, both through external collaborations and internally through its two patented transgenic mouse platforms for therapeutic antibody discovery. The company also licenses its platforms to companies and academic institutions through its Harbour Antibodies subsidiary.
Harbour BioMed has an R&D site in Shanghai; business operations and an innovation center with a research lab in Newton, MA; and an antibody platform innovation center in Rotterdam, The Netherlands. The company was established in 2016 with $50 million in series A financing, and on January 22 announced its completion of a Series A+ financing round whose value was undisclosed, led by CDH Investments, with series A investor Advantech Capital participating