BDTX-1535 shows 5/12 NSCLC patients with confirmed partial response; expansion cohorts planned

Black Diamond Therapeutics, Inc.

5 of 12 evaluable NSCLC patients achieved confirmed partial response per RECIST 1.1; 1 unconfirmed PR, 6 stable disease.
No dose-limiting toxicity at 15-200 mg QD; DLTs observed at 300 mg (1/15) and 400 mg (5/12).
Enrollment to start at 200 mg QD in two NSCLC expansion cohorts targeting acquired resistance and intrinsic driver mutations.
FDA meeting planned in H2 2023 to discuss dosing strategy and potential accelerated approval path.
Phase 1 GBM dose escalation update expected in Q4 2023.

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