Relay Therapeutics Licenses Experimental Therapy for Rare Cancers to Elevar

Rare Daily Staff

Relay Therapeutics has granted an exclusive worldwide license to Elevar Therapeutics for its experimental therapy lirafugratinib for FGFR2-drive cholangiocarcinoma and other FGFR2-altered solid tumors.

Under the terms of the agreement, 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.

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.

The partnership follows Relay’s recent positive interaction with the U.S. Food and Drug Administration and previously reported differentiated data in cholangiocarcinoma and data across other solid tumors.

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.

Lirafugratinib is a selective oral small molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2) that is being developed for patients with FGFR2-driven CCA. Lirafugratinib was granted breakthrough therapy designation and orphan drug designation by the FDA.

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.

“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,” said Sanjiv Patel, president and CEO 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.”

Photo: Sanjiv Patel, president and CEO of Relay Therapeutics