The parties have already started generating fully human anti-PD-1 antibody product candidates under Ono’s intellectual property regarding PD-1 and using Medarex’s proprietary UltiMAb Human Antibody Development System. They expect clinical studies to begin in 12 to 24 months.
Under this arrangement, Ono and Medarex will jointly work toward potential commercialization of an anti-PD-1 antibody. The two companies plan to share the costs and responsibilities of research and product development up to the completion of a phase II clinical study.
Thereafter, each company will be fully responsible for any continued development and any commercialization in its exclusive territory; Medarex’s exclusive territory is North America, and Ono’s exclusive territory is all areas outside of North America.
PD-1 is a receptor that is part of a signaling pathway that may be exploited by tumor cells to escape immune responses. The novel antibody has been designed to block this signaling pathway in order to potentially enhance the ability of the patient’s immune system to attack the cancer cells.
“We have performed functional research with various genes encoding secreted proteins, which were isolated in the course of exploration of innovative physiologically active substances and discovery targets,” said Dr Kigen Kondoh, executive director of research headquarters at Ono. “PD-1 is one of our gene assets resulting from such exploratory research. We expect to significantly expand the potential development of pharmaceutical products against this novel discovery target through our collaboration with Medarex.”