After pausing work on a rare cancer asset, Relay Therapeutics is passing the baton to Elevar Therapeutics. The two have signed a deal worth up to $500 million biobucks that gives Elevar licensing rights to an investigational oral small molecule designed to treat solid tumors.
Relay is handing off exclusive global development and commercialization rights for lirafugratinib, a fibroblast growth factor receptor 2 (FGFR2) inhibitor also known as RLY-4008, according to a Dec. 3 release. The Cambridge, Massachusetts-based biotech will be eligible to receive $75 million in upfront and regulatory milestones and up to $425 million in potential commercial milestones, plus royalties.
In return, South Korea-based HCB subsidiary Elevar will take on responsibility of all activities, including a new drug approval (NDA) submission and global commercialization for the drug in FGFR2-driven cholangiocarcinoma (CCA)—a rare bile duct cancer—and other FGFR2-altered solid tumors.
Lirafugratinib has snagged both breakthrough therapy and orphan drug tags from the FDA.
Back in October 2023, Relay paused hopes of bringing lirafugratinib to the market in CCA, citing the impact of the Inflation Reduction Act. The shift in strategy came after new data showed the candidate could work in cancers other than the rare bile duct cancer. At the time, Relay CEO Sanjiv Patel told investors how the data and changes to the commercial environment both contributed to the decision.
Meanwhile, lirafugratinib is currently being studied in a global phase 1/2 trial in patients with FGFR2-altered tumors, including a pivotal cohort in FGFR2-fusion CCA that was designed to support accelerated approval and is fully enrolled. Earlier this year, Relay met with the FDA to discuss data from the ReFocus trial, with the agency recommending an initial NDA filing in FGFR2-driven CCA, followed by a supplemental NDA for FGFR2-altered other solid tumors, according to the release.
Now, Elevar is picking up the “NDA-ready” asset, giving Relay the ability to focus on its PI3Kα programs, including the launch of a pivotal breast cancer trial next year, Patel said in the Dec. 3 release.
The Elevar deal should offer Relay some relief after a tough season. Earlier this year, the precision medicine biotech implemented two layoff rounds—one in July and one announced in October. Fewer than 5% of employees at the biotech were impacted by the first round, and about 30 roles were cut in the second wave.
“Over the course of 2024, we have been streamlining our research organization through a series of changes,” a Relay spokesperson told Fierce at the time. The process is designed to improve efficiency and expected to collectively save the biotech about $50 million a year, according to the spokesperson.
Relay lost a key partnership in July when Roche’s Genentech returned rights to an SHP2 inhibitor—one of many SHP2 deal terminations made by Big Pharma players over the past few years. Relay quickly lost interest in the program, removing the SHP2 candidate from its pipeline in August.