FDA Allows Black Diamond Therapeutics For New BDTX-1535 Study

Black Diamond Therapeutics, Inc. today announced that the US Food and Drug Administration has approved it’s Investigational New Drug (IND) for its MasterKey inhibitor, BDTX-1535. This is an irreversible, brain-penetrant, selective, and oncogenic inhibitor of the epidermal growth factor receptor’s (EGFR) oncogenic mutation. Black Diamond Therapeutics is pleased to announce that the FDA has allowed its Investigational New Drug (IND) for its pipeline candidate, BDTX-1535. The company believes that this potential treatment for patients with tympanierzkin mutation-driven NSCLC and EGFR mutant GBM is well-suited to address the needs of these patients.

Black Diamond has shown that the distinct features of the oncogenic alterations of EGFR can confer unique characteristics, such as drug resistance and potentiation. In cell-based assays, BDTX-1535 selectively and robustly inhibited the expression of various EGFR mutations. BDTX-1535 is a brain-penetrant inhibitor that is designed to block the oncogenic mutation of the epidermal growth factor receptor. In various tumor models, including those with the targeted EGFR mutations, the company’s pipeline candidate exhibited complete regression without weight loss.