" class="no-js "lang="en-US"> Erasca Announces Exclusive Worldwide License for Pan-RAF Inhibitor Naporafenib - Medtech Alert
Monday, April 15, 2024

Erasca Announces Exclusive Worldwide License for Pan-RAF Inhibitor Naporafenib

Erasca, a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, has announced it has entered into an exclusive worldwide license agreement with Novartis for naporafenib, a Phase 2 pivotal-ready pan-RAF inhibitor with a potential first-in-class and best-in-class profile in NRAS mutant (NRASm) melanoma and other RAS/MAPK pathway-driven tumors.

To date, naporafenib has been dosed in over 500 patients across multiple trials and has demonstrated preliminary clinical proof-of-concept as well as favorable safety and tolerability data both as a single agent and in combination with other molecularly targeted and immuno-oncology therapies. As separately announced, Erasca has priced a $100 million equity offering with select healthcare investors.

“Naporafenib aligns with our mission by expanding our addressable patient population and is a perfect strategic fit for Erasca based on its strong synergy with our pipeline,” said Jonathan Lim, Erasca chairman, CEO, and co-founder. “This Phase 2 pivotal-ready molecule with favorable clinical safety, tolerability, and proof-of-concept data significantly accelerates our transition into a late-stage development company, bringing us closer to realizing our aspiration of delivering novel cancer therapies to patients in need. This license, coupled with our simultaneous financing from leading healthcare investors, solidifies our leadership in advancing treatments for RAS/MAPK pathway-driven cancers.”

Naporafenib (LXH254) is a potent and selective inhibitor of BRAF and CRAF, with a potential first-in-class and best-in-class profile. Safety, tolerability, and preliminary proof of concept of naporafenib alone or in combination have been shown in over 500 patients treated to date in NRASm melanoma and other RAS/MAPK pathway-driven tumors. Erasca plans to initially focus on advancing and securing potential regulatory approval for naporafenib plus trametinib (MEKINIST®) in RAS Q61X tissue agnostic solid tumors as part of the planned Phase 2 SEACRAFT-1 trial and NRASm melanoma as part of the planned Phase 3 SEACRAFT-2 trial.

Under the terms of the license agreement, in exchange for an exclusive worldwide license to develop and commercialize naporafenib, Erasca will pay to Novartis a one-time upfront cash payment of $20 million and $80 million of shares in Erasca common stock at a price of $6.50 per share. Novartis is eligible to receive up to $80 million in cash upon the achievement of regulatory milestones covering two indications in the United States, Europe, and Japan, as well as up to $200 million in cash upon the achievement of sales milestones. Novartis is also eligible to receive a low single-digit percentage royalty on net sales of naporafenib.

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