Black Diamond Therapeutics, Inc.

Black Diamond Therapeutics is a clinical-stage oncology company that develops MasterKey therapies designed to target families of cancer-causing mutations in patients with cancer. The company's approach is based on understanding cancer genetics, onco-protein structure and function, and medicinal chemistry. MasterKey therapies aim to treat a wide range of genetically defined tumors, overcome drug resistance, reduce side effects on healthy cells, and penetrate the brain to treat central nervous system (CNS) diseases. These compounds target families of cancer-causing mutations in established biological pathways. The company's main clinical-stage program is silevertinib (formerly BDTX-1535), a brain-penetrant, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor. Silevertinib is currently in a Phase 2 clinical trial for patients with epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC). The company plans to start a randomized Phase 2 trial of silevertinib in newly diagnosed patients with EGFR altered glioblastoma (GBM) in the second quarter of 2026. Black Diamond Therapeutics aims to provide targeted oncology medicine to patients with genetically defined cancers who have limited treatment options. Their drug development uses findings that mutations throughout a gene can activate cancer and change how drugs interact with their active sites; these mutations can be grouped into families due to similar protein structural changes and shared drug selectivity; and a single molecule can inhibit a family of cancer-causing proteins by targeting the active site. MasterKey therapies were discovered using the proprietary MAP drug discovery engine, which focuses on identifying oncogenic mutations, confirming their cancer-causing nature using cell and tumor models, and pharmacologically inhibiting these mutations while sparing healthy cells.