Relay Therapeutics Inc, a precision medicine company specializing in drug discovery through advanced computational and experimental methods, and Elevar Therapeutics Inc, a division under HLB Co Ltd and a comprehensive biopharmaceutical entity committed to enhancing treatment success for patients without sufficient medical solutions, have declared an exclusive worldwide licensing deal for lirafugratinib (RLY-4008).
Lirafugratinib is a targeted oral medication designed to inhibit fibroblast growth factor receptor 2 (FGFR2) and is being developed for individuals with FGFR2-related cholangiocarcinoma (CCA) and other FGFR2-modified solid tumors.
Cholangiocarcinoma, also known as bile duct cancer, is an uncommon cancer forming in the bile ducts, affecting around 8,000 individuals annually in the United States.
This collaborative agreement follows Relay’s favorable interaction with the US FDA and previously highlighted promising outcomes in cholangiocarcinoma and other solid tumors.
“Preliminary data indicate that lirafugratinib may become a significant new treatment for patients dealing with FGFR2-related cholangiocarcinoma and other FGFR2-modified solid tumors. We’re thrilled that Elevar will drive its development and harness their expanding commercial strength to make it accessible globally,” stated Sanjiv Patel, president and CEO of Relay Therapeutics. “Through this partnership, we remain dedicated to progressing our PI3Ka projects, including launching the RLY-2608 2L breast cancer clinical trial and vascular malformations trial next year.”
“With an NDA-ready status, lirafugratinib has shown potentially leading efficacy in FGFR2-influenced cholangiocarcinoma and other FGFR2-modified solid tumors, especially in advanced phases where treatments are scarce,” commented Saeho Chong, CEO of Elevar Therapeutics. “We are eager to broaden and enhance our advanced oncology pipeline with lirafugratinib, complementing our existing cancer portfolio and pushing forward our mission of delivering transformative medicines to cancer patients worldwide.”
Lirafugratinib has achieved breakthrough therapy and orphan drug status from the US FDA. It is undergoing evaluation in the global ReFocus study targeting FGFR2-modified tumors.
The trial incorporates a critical cohort of patients with FGFR2-fusion CCA aimed at expedited approval, now fully recruited. Interim findings were shared at the European Society for Medical Oncology Conference in 2022.
Additional cohorts in the study also encompass other solid tumors such as gastric, pancreatic, and head and neck cancers. Interim results from these groups were disclosed at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapies in 2023 and 2024.
Earlier in 2024, Relay Therapeutics conferred with the US FDA on data from the ReFocus study and prospective regulatory paths. The US FDA advised initially submitting an NDA for FGFR2-driven CCA, followed by a supplemental NDA for FGFR2-modified other solid tumors based on data from an expanded patient cohort.
Per the agreement, Elevar will gain global development and marketing rights to lirafugratinib, taking full charge of further development, NDA submissions, additional clinical trials, and worldwide commercialization for FGFR2-linked CCA and other FGFR2-altered solid tumors.
Relay Therapeutics could receive up to $75 million through upfront and regulatory milestones, plus up to $425 million in potential commercial milestone earnings, along with tiered royalties reaching the low-teens percentage.