On December 3, 2024 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, and Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and fully integrated biopharmaceutical company dedicated to elevating treatment outcomes for patients who have limited or inadequate therapeutic options, reported an exclusive global licensing agreement for lirafugratinib (RLY-4008) (Press release, Elevar Therapeutics, DEC 3, 2024, View Source [SID1234648745]). Lirafugratinib is a selective oral small molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2) that is being developed for patients with FGFR2-driven cholangiocarcinoma (CCA) and other FGFR2-altered solid tumors. The announcement of the partnership follows Relay’s recent positive FDA interaction and previously reported differentiated data in cholangiocarcinoma and data across other solid tumors.

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"Data to-date show that lirafugratinib has the potential to be an important novel medicine for patients with FGFR2-driven cholangiocarcinoma and other FGFR2-altered solid tumors. We are pleased that Elevar will continue its development and leverage their growing commercial capabilities to bring it to patients in need around the world," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "As a result of this agreement, we are able to remain fully focused on continuing to advance our PI3Kα programs, including initiating the RLY-2608 2L breast cancer pivotal trial and vascular malformations trial next year."

"Lirafugratinib is an NDA-ready therapy that has shown a potential best-in-class profile in both FGFR2-driven cholangiocarcinoma and in other FGFR2-altered solid tumors including in advanced stages where treatment options are limited," said Saeho Chong, Ph.D., chief executive officer of Elevar Therapeutics. "We are excited to diversify and expand our late-stage oncology pipeline with lirafugratinib, which is a strong strategic fit with our existing oncology portfolio and provides another opportunity to advance our mission of bringing life-changing medicines to cancer patients worldwide."

Lirafugratinib was granted breakthrough therapy designation and orphan drug designation by the FDA. Lirafugratinib is being investigated in the global ReFocus trial in patients with FGFR2-altered tumors. The study includes a pivotal cohort in patients with FGFR2-fusion CCA that was designed to support accelerated approval and is fully enrolled. Interim data from this cohort were presented at the European Society for Medical Oncology Congress in 2022. The study also includes cohorts in patients with other types of solid tumors, including gastric, pancreatic, and head and neck tumors. Interim data from these cohorts were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in 2023 and 2024. Earlier in 2024, Relay Therapeutics met with the U.S. Food and Drug Administration (FDA) to discuss data from the ReFocus trial and potential regulatory pathways. The FDA recommended that the company first file an NDA for FGFR2-driven CCA, followed by a supplemental NDA for FGFR2-altered other solid tumors with data from an expanded cohort of patients.

Cholangiocarcinoma (CCA) or bile duct cancer is a rare disease in which malignant cells form in the bile ducts. Approximately 8,000 people in the United States are diagnosed with CCA each year.

Terms of the Agreement

Under the terms of the agreement, Elevar will be granted global development and commercialization rights for lirafugratinib. Elevar will assume full responsibility for all further development activities, including submission of the NDAs, all subsequent clinical development, and global commercialization for FGFR2-driven CCA and FGFR2-altered other solid tumors.

Relay Therapeutics is eligible to receive up to $75 million in upfront and regulatory milestones, plus up to $425 million in potential commercial milestone payments, as well as tiered royalties up to the low-teens percentage.

Moelis & Company LLC is serving as exclusive financial advisor to Relay Therapeutics in the transaction. Goodwin Procter LLP is serving as exclusive legal advisor to Relay Therapeutics in the transaction.

About Lirafugratinib

Lirafugratinib (RLY-4008) is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, lirafugratinib demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models with minimal inhibition of other targets, including other members of the FGFR family. In addition, lirafugratinib demonstrated strong activity against known clinical on-target resistance mutations in cellular and in vivo preclinical models. Lirafugratinib is currently being evaluated in a clinical trial in patients with advanced or metastatic FGFR2-altered solid tumors with a single arm, potentially registration-enabling cohort for FGFRi-naïve FGFR2-fusion CCA.