Regeneron Pharmaceuticals and Zai Lab announced a strategic collaboration for the development and commercialization of REGN1979 (CD20xCD3 bispecific antibody) in mainland China, Hong Kong, Taiwan and Macau. The collaboration will support global clinical development for REGN1979, starting with the ongoing potentially registrational Phase 2 program in B-cell non-Hodgkin lymphoma (B-NHL).
Additionally, if REGN1979 is approved, Zai Lab will leverage its capabilities to commercialize REGN1979 in this region. REGN1979 is the most advanced investigational bispecific monoclonal antibody from Regeneron’s bispecific platform and is designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).
Under the terms of the agreement, Regeneron will receive a $30 million upfront payment and is eligible to receive up to $160 million in additional regulatory and sales milestones. Zai Lab will contribute to the global development costs for REGN1979 for certain trials and will receive the rights to develop and exclusively commercialize REGN1979 in oncology in mainland China, Hong Kong, Taiwan and Macau. Additionally, Zai Lab will make payments to Regeneron based on net sales, such that Regeneron shares in a significant portion of any potential profits. Regeneron will be responsible for the manufacture and supply of REGN1979 for development and commercialization in the region.
“Zai Lab is an ideal collaborator for us, with an established and respected track record that aligns with our mission to use the power of science to repeatedly bring new medicines to patients with serious diseases,” said Israel Lowy, M.D., Ph.D., Senior Vice President and Head of Clinical and Translational Sciences for Oncology at Regeneron. “Zai’s support will not only help bolster enrollment into global REGN1979 trials, but will also enable this promising investigational medicine to reach patients faster in this key region, if approved.”
“Regeneron is a global leader in the research and development of innovative medicines, and we are delighted to collaborate on the investigational bispecific antibody REGN1979 as we expand our oncology franchise into hematologic cancers,” said Samantha Du, Ph.D., Founder, Chairperson and Chief Executive Officer at Zai Lab. “Zai looks forward to contributing significantly to the success of REGN1979 with our regulatory and clinical expertise, and commercial footprint in mainland China, Hong Kong, Taiwan and Macau. We are committed to collaborating with Regeneron to expand its global effort and bring innovative medicines to patients with unmet medical needs.”
REGN1979 was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). REGN1979 is currently being investigated as a treatment for late stages of FL, DLBCL and other lymphomas in a Phase 1 trial as well as a potentially registrational Phase 2 trial. Positive data for REGN1979 from the Phase 1 trial were last shared at the 2019 American Society of Hematology (ASH) Annual Meeting.