Relay and Elevar Therapeutics Announce Global License Agreement for Lirafugratinib in FGFR2-Driven Cancers

Relay Therapeutics and Elevar Therapeutics have entered into a global licensing agreement granting Elevar the exclusive rights to develop and commercialize lirafugratinib (RLY-4008), a selective oral small molecule inhibitor targeting FGFR2. This partnership allows Elevar to take charge of the development and distribution of lirafugratinib, a potential best-in-class FGFR2 inhibitor that has shown promising results in treating FGFR2-driven cholangiocarcinoma (CCA) and other FGFR2-altered solid tumors.

Lirafugratinib has demonstrated significant efficacy in preclinical and clinical trials, including studies showing durable responses in multiple FGFR2-altered tumors. The drug was developed to target FGFR2, a receptor tyrosine kinase often altered in certain cancers, and has shown minimal inhibition of other targets, including other FGFR family members. This specificity may contribute to its potential as a leading treatment option for FGFR2-driven cancers.

Relay Therapeutics, a company focused on advancing precision medicine through innovative drug discovery techniques, will receive up to $500 million in upfront, regulatory, and commercial milestone payments from Elevar. This includes $75 million upfront and regulatory milestones, as well as potential royalties from global sales. The agreement allows Relay Therapeutics to maintain its focus on advancing other programs, such as its PI3Kα initiatives, including upcoming pivotal trials in breast cancer and vascular malformations.

Elevar Therapeutics, a biopharmaceutical company committed to improving treatment outcomes for patients with limited options, will spearhead the further development of lirafugratinib. The company’s CEO, Saeho Chong, expressed enthusiasm for incorporating lirafugratinib into their oncology pipeline, highlighting its strategic fit and potential to bring life-changing treatments to cancer patients worldwide.

The ReFocus trial, a global study investigating lirafugratinib, includes a pivotal cohort of patients with FGFR2-fusion CCA, designed to support accelerated approval. This cohort is fully enrolled, and interim data were presented at the European Society for Medical Oncology Congress in 2022. The trial also includes cohorts of patients with other FGFR2-altered solid tumors, such as gastric, pancreatic, and head and neck tumors, with interim data presented at major conferences in 2023 and 2024.

Earlier in 2024, Relay Therapeutics met with the FDA to discuss the ReFocus trial data and potential regulatory pathways. The FDA recommended an initial NDA filing for FGFR2-driven CCA, followed by a supplemental NDA for other FGFR2-altered solid tumors based on expanded cohort data.

Cholangiocarcinoma (CCA) is a rare cancer affecting the bile ducts, with approximately 8,000 new cases diagnosed annually in the United States. The licensing agreement stipulates that Elevar will handle all further development activities for lirafugratinib, including NDA submissions, clinical development, and global commercialization for both FGFR2-driven CCA and other FGFR2-altered tumors.

Relay Therapeutics' precision medicine approach integrates advanced computational and experimental methods to transform drug discovery, with a focus on targeted oncology and genetic diseases. Elevar Therapeutics, rooted in oncology expertise, is dedicated to advancing promising treatments for complex, under-treated health conditions.

The partnership between Relay Therapeutics and Elevar Therapeutics represents a strategic collaboration aimed at bringing a novel and potentially life-saving treatment to patients with FGFR2-altered cancers, underscoring both companies’ commitment to innovation and improving patient outcomes.