TARRYTOWN, N.Y. & SHANGHAI, China—Regeneron Pharmaceuticals Inc. and Zai Lab Ltd. recently reported a strategic collaboration for the development and commercialization of REGN1979 (CD20xCD3 bispecific antibody) in mainland China, Hong Kong, Taiwan and Macau.
“Due to our longstanding relationships, pioneer status and execution track record, Zai Lab benefits significantly from a strong global reputation as the partner of choice. So there is robust inbound and outbound activities in terms of [business development] and partnership opportunities. Oftentimes, we have known these potential partners for many years before we enter into a formal collaboration agreement,” notes Dr. Samantha Du, who is founder, chairperson and CEO at Zai Lab. “This is the first formal collaboration and partnership between Regeneron and Zai Lab. We certainly look forward to working closely with them over the long term.”
REGN1979 is currently being investigated as a treatment for late stages of follicular lymphoma, diffuse large B cell lymphoma and other lymphomas in a Phase 1 trial, as well as the ongoing potentially registrational Phase 2 trial in B cell non-Hodgkin lymphoma. Positive data for REGN1979 from the Phase 1 trial were last shared at the 2019 American Society of Hematology Annual Meeting.
“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 Dr. Israel Lowy, 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.”
If the therapy is approved, Zai Lab will 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).
“With this collaboration, we will support global clinical development for REGN1979, starting with the ongoing potentially registrational Phase 2 program in B-cell non-Hodgkin lymphoma,” explains Du. “We will explore opportunities in oncology that fit into our long-term strategy, and opportunities that address the unmet medical needs in mainland China, Hong Kong, Taiwan and Macau. By leveraging our strong existing capabilities in regulatory and commercial, we are committed to collaborating with Regeneron to expand its global effort and bring innovative medicines to patients with unmet medical needs.”
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. Zai Lab will also make payments to Regeneron based on net sales, so that Regeneron will share 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.
“Regeneron has a history of finding strong strategic partners for global development and commercialization,” Du adds. “Regeneron’s decision to collaborate with us reflects not only the large market opportunity in China, but also Zai Lab’s track record of delivering and driving exceptional clinical development and commercial execution. Zai will contribute Chinese patients into REGN1979’s ongoing potential pivotal Phase 2 program to support global clinical development. We are excited to partner with Regeneron, and we believe they are the ideal partner for us as we continue to expand our platform.”
“2020 will be another pivotal year for Zai Lab as we have or expect to file three submissions for approval, two product launches in China, deliver key clinical readouts, and advance two discovery programs with global-rights to IND submission. This collaboration expands our oncology pipeline into hematological cancer and marks a strong footprint towards our goal to become a leading global biopharma company,” Du states. “RGNE1979 is a potential first-in-class hemonc [hematology/oncology] asset in our region. The unmet medical need and commercial potential in NHL is significant, which makes the CD3xCD20 bispecific class a potentially large market opportunity.”