NEW YORK – Servier has signed a global licensing agreement with Black Diamond Therapeutics to develop and commercialize BDTX-4933 for treating RAF- and RAS-mutant solid tumors, including non-small cell lung cancer.
In the deal announced Wednesday, Servier said it will pay Black Diamond $70 million upfront and up to $710 million in development and commercial sales milestones and tiered royalties based on global net sales. Servier will be in charge of development activities and global commercialization of the drug in multiple solid tumor indications.
BDTX-4933 inhibits oncogenic RAF or RAS mutations, including in BRAF, KRAS, NRAS, and NF1. In preclinical studies, BDTX-4933 showed robust and sustained target engagement and dose-dependent inhibition of tumor growth.
Black Diamond is conducting a Phase I trial of BDTX-4933 in patients with solid tumors. In the initial dose-escalation portion, researchers are enrolling patients with recurrent, advanced NSCLC whose cancers harbor BRAF, CRAF, or KRAS mutations other than G12C mutations; patients with advanced or metastatic melanoma with BRAF, CRAF, or NRAS mutations; those with histiocytic neoplasms with BRAF, CRAF, or NRAS mutations; and other individuals with BRAF-mutated solid tumors. The dose-expansion part of the trial will comprise patients with recurrent, advanced NSCLC with KRAS mutations other than G12C. Investigators are tracking safety, tolerability, and measures of efficacy, including overall response rate, progression-free survival, and overall survival.
Cambridge, Massachusetts-based Black Diamond announced in October 2024 that it was restructuring its workforce, deprioritizing development of BDTX-4933, and refocusing its resources on advancing the EGFR inhibitor BDTX-1535. At the time, the firm said it was actively seeking a partner with which to move BDTX-4933 forward in clinical studies.
"Our partnership to develop BDTX-4933 is an important opportunity in targeted cancer therapies as we believe we can serve more people by helping the right patients find the right treatment, at the right time," Claude Bertrand, executive VP of R&D at Servier, said in a statement.