Black Diamond Therapeutics Announces Corporate Update and Expected 2024 Milestones

FDA feedback on BDTX-1535 enables initiation of Phase 2 cohort in first-line treatment of non-classical EGFR mutant NSCLC

Fast Track Designation granted for BDTX-1535 as second-line treatment for EGFR mutant/C797S NSCLC

BDTX-1535 Phase 2 results for 2L/3L patients with EGFR mutant NSCLC expected Q3 2024

BDTX-1535 Phase 1 clinical trial results and “window of opportunity” data in patients with EGFR mutant GBM expected to be presented at a medical meeting in Q2 2024

BDTX-4933 Phase 1 results in patients with KRAS mutant NSCLC expected Q4 2024

Existing cash, cash equivalents and investments expected to be sufficient to fund milestone achievements and operations into Q2 2025

CAMBRIDGE, Mass., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today provided a corporate update outlining clinical development plans and anticipated corporate milestones for 2024.

“We made significant progress in 2023 and sharpened our focus on our clinical programs: BDTX-1535 in both EGFR mutant NSCLC and GBM, and BDTX-4933 in KRAS mutant NSCLC,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer of Black Diamond Therapeutics. “In 2024, we anticipate key readouts from each of these programs, including Phase 2 data from BDTX-1535 in NSCLC. Moreover, recent FDA feedback enables the enrollment of first-line NSCLC patients into the Phase 2 trial, reflecting the potential of BDTX-1535 to benefit patients in earlier lines of therapy. Due to disciplined spend, we expect our cash to be sufficient for this year’s milestones and to extend into the second quarter of 2025.”

Clinical Program Updates/Anticipated 2024 Milestones

BDTX-1535 in patients with Epidermal Growth Factor Receptor (EGFR) mutant Non-Small Cell Lung Cancer (NSCLC)

• Dose escalation results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October 2023. Phase 2 data in second/third-line patients with EGFR mutant NSCLC are expected in the third quarter of 2024. The Company intends to discuss Phase 2 results with the U.S. Food and Drug Administration (FDA) to finalize a pivotal clinical trial design.
• BDTX-1535 received Fast Track Designation for the treatment of patients with EGFR mutant C797S-positive NSCLC whose disease has progressed on/after a third-generation EGFR tyrosine kinase inhibitor (TKI).
• Following End of Phase 1 feedback received from the FDA in the fourth quarter of 2023, a Phase 2 cohort in first-line patients with non-classical EGFR mutant NSCLC is being initiated.
• The Company is also exploring the potential development of BDTX-1535 in first-line patients who are post-osimertinib adjuvant treatment.

BDTX-1535 in patients with EGFR mutant Glioblastoma (GBM)