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

Relay Therapeutics and Elevar Therapeutics have entered into a worldwide licensing agreement for the development and commercialization of lirafugratinib (RLY-4008), a selective FGFR2 inhibitor. Lirafugratinib is being developed to treat FGFR2-driven cholangiocarcinoma and other FGFR2-altered solid tumors, with promising data already observed in initial trials.

Relay Therapeutics, based in Cambridge, Massachusetts, is a clinical-stage precision medicine company employing advanced computational and experimental technologies to revolutionize drug discovery. Elevar Therapeutics, headquartered in Fort Lee, New Jersey, is a subsidiary of HLB Co., Ltd., and focuses on providing new treatment options for patients with limited available therapies.

Under the terms of the agreement, Elevar Therapeutics gains global rights to develop and commercialize lirafugratinib. Elevar will oversee all aspects of development, including the submission of New Drug Applications (NDAs) and global commercialization efforts for FGFR2-driven cholangiocarcinoma and other FGFR2-altered solid tumors.

Relay Therapeutics stands to receive up to $500 million in payments, comprising $75 million in upfront and regulatory milestones, with an additional $425 million in potential commercial milestone payments. Relay will also benefit from tiered royalty payments based on global sales.

Lirafugratinib has been granted both breakthrough therapy and orphan drug designations by the FDA, reflecting its potential in treating FGFR2-driven cancers. The ongoing global ReFocus trial investigates lirafugratinib's efficacy in patients with FGFR2-altered tumors, including a pivotal cohort for patients with FGFR2-fusion cholangiocarcinoma designed to support accelerated approval. Data from this trial were presented at key oncology conferences, demonstrating durable responses across various solid tumors.

Dr. Sanjiv Patel, President and CEO of Relay Therapeutics, expressed satisfaction with the partnership, emphasizing its potential to provide a new therapeutic option for patients with FGFR2-driven cancers. He noted that the agreement allows Relay to concentrate on advancing its PI3Kα programs, including the pivotal trials for RLY-2608.

Dr. Saeho Chong, CEO of Elevar Therapeutics, highlighted lirafugratinib's readiness for NDA submission and its best-in-class profile. He emphasized that the addition of lirafugratinib to their oncology pipeline aligns with Elevar's mission to deliver transformative treatments to cancer patients globally.

Cholangiocarcinoma, a rare bile duct cancer, affects around 8,000 individuals annually in the United States. The promising efficacy of lirafugratinib positions it as a significant advancement for patients with this challenging condition.

In preclinical studies, lirafugratinib demonstrated potent FGFR2 inhibition with minimal off-target effects, and strong activity against known resistance mutations. It is currently under evaluation in a clinical trial for patients with advanced FGFR2-altered solid tumors, including a single-arm cohort for FGFR2-fusion cholangiocarcinoma.

Relay Therapeutics is focused on transforming drug discovery by integrating cutting-edge computational and experimental methods to target previously intractable proteins. Their initial efforts are directed at small molecule therapeutics in oncology and genetic diseases.

Elevar Therapeutics, leveraging its oncology expertise, is dedicated to developing innovative medicines for complex diseases with unmet medical needs. Their lead candidate, rivoceranib, is under FDA review for hepatocellular carcinoma.

The agreement paves the way for Elevar Therapeutics to bring lirafugratinib to a global market, potentially offering new hope for patients with difficult-to-treat cancers.