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Black Diamond Therapeutics IND for BDTX-1535 Cleared by FDA

NEW YORK – Black Diamond Therapeutics on Tuesday said the US Food and Drug Administration has accepted its investigational new drug application for its MasterKey inhibitor BDTX-1535, allowing it to begin studying the therapy in patients with EGFR-mutated glioblastoma multiforme and non-small cell lung cancer.

The Cambridge, Massachusetts-based drug developer said it hopes to start a Phase I trial of BDTX-1535 in the first quarter of 2022 and provide a clinical update in the second half of 2023.

BDTX-1535 is designed to penetrate the blood-brain barrier and has shown activity in preclinical studies against multiple EGFR mutations that occur in GBM and NSCLC, including canonical, non-canonical, and drug-resistance mutations. For example, the drug appears to inhibit EGFR-C797S, a mutation that occurs in patients treated with third generation EGFR inhibitors.

The company estimates that around half of GBM patients have cancer-associated EGFR mutations, which translates to an annual market of 60,000 patients in the US, EU, Japan, and China that could potentially be addressed by BDTX-1535. In the same markets, there are around 20,000 patients each year who are diagnosed with NSCLC characterized by an EGFR intrinsic or acquired resistance mutation.