Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Vyriad, Inc. today announced a research collaboration and option licensing agreement focused on the development of new oncolytic (cancer-killing) virus-based treatments for various forms of cancer. The agreement includes a Phase 2 clinical study, slated to begin in 2020, evaluating Regeneron's PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in combination with Vyriad's oncolytic virus Voyager-V1 in multiple types of cancer, including melanoma, lung, liver and endometrial cancers. The companies will also enter into a five-year research effort that utilizes Regeneron's VelociSuite® technologies to jointly design and validate novel Vesicular Stomatitis Virus (VSV)-based oncolytic virus treatments.
Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is being jointly developed and commercialized by Regeneron and Sanofi under a global collaboration agreement. Libtayo was invented by Regeneron using the company's proprietary VelocImmune® technology which uses a unique genetically-humanized mouse to produce optimized fully-human antibodies.
Vyriad's investigational drug candidate Voyager-V1 is a potent VSV programmed to attack cancer cells selectively, while also activating the immune system to kill local and distant cancer cells. Further, it amplifies inflammatory and antitumor immune system responses that help turn "cold" tumors "hot," which potentially enhances anti-PD-1 activity. Voyager-V1 is deliverable by intravenous infusion.
"Vyriad's differentiated oncolytic virotherapy platform helps Regeneron continue to diversify our arsenal of immuno-oncology approaches, which include multiple combinations with our anti-PD-1 backbone, as well as novel delivery and re-targeting mechanisms," said Israel Lowy, M.D., Ph.D., Senior Vice President and Head of Clinical and Translational Sciences, Oncology at Regeneron. "We are eager to explore the combination of Voyager-V1 and Libtayo in patients with different tumor types in the short term, and see long-term promising synergies with our existing areas of strength, particularly in antibody development and viral vector technologies. We look forward to working together to help cancer patients in need."
"We are thrilled to partner with Regeneron in this far-reaching collaboration to develop novel cancer treatments," said Stephen Russell, M.D., Ph.D., President and Chief Executive Officer of Vyriad. "We are optimistic that the clinical combination of Voyager-V1 with Libtayo will result in effective anticancer activity, and we are very excited to join forces with Regeneron scientists to develop a new generation of precision targeted VSV therapies. Through the collaboration, we expect that the emerging power of oncolytic virotherapy can finally integrate with proven capabilities of antibody engineering, with the potential to create life-changing medicines for cancer patients."
Under the agreement, Vyriad will receive an upfront payment and Regeneron will make an equity investment in the company. Regeneron will have an exclusive option to license Voyager-V1 and other collaboration products. Vyriad is eligible to receive additional payments based on the achievement of specified development and commercial milestones, as well as royalties on net sales of potential future VSV-based collaboration products. During the five-year collaboration term, Vyriad will work exclusively with Regeneron to research and develop VSV technologies. Specific financial terms were not disclosed.