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Black Diamond Therapeutics Presents Phase 1 Pharmacokinetic, Safety, and Preliminary Efficacy Data of BDTX-189 in Advanced Solid Tumors Harboring EGFR or HER2 Alterations
Once-daily (QD) dose escalation completed; pharmacokinetic (PK) profile consistent with design principles and preclinical predictions Generally well-tolerated
About this update from Black Diamond Therapeutics, Inc.
[{"type":"text","content":"Once-daily (QD) dose escalation completed; pharmacokinetic (PK) profile consistent with design principles and preclinical predictions Generally well-tolerated with medically manageable toxicities observed; safety profile compares favorably in the context of other agents in the class; preliminary recommended Phase 2 dose (RP2D) selected for the QD regimen Preliminary anti-cancer activity observed in heavily pre-treated patients (prior EGFR/HER2-directed and/or I/O agents) in a variety of tumor types and genomic alterations in EGFR or HER2, including confirmed partial responses Conference call and webcast to be held today at 6:00 PM ET CAMBRIDGE, Mass. and NEW YORK, May 19, 2021 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, MasterKey therapies, today announced initial data from the Phase 1 dose-escalation portion of the MasterKey-01 trial of BDTX-189 in patients with advanced solid tumors harboring any one of more than 48 oncogenic alterations in the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) oncogenes. These data provide early proof-of-concept for BDTX-189, including evidence of anti-cancer activity and a safety profile that is in-line with the Company’s preclinical expectations. The data announced today will be presented in poster presentations at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 4-8, 2021. “These encouraging Phase 1 safety and anti-cancer activity data provide early proof-of-concept for BDTX-189 as a differentiated MasterKey inhibitor of undrugged oncogenic mutants of EGFR, including EGFR Exon 20 insertion mutations and oncogenic mutants of HER2,” said Rachel Humphrey, M.D., Chief Medical Officer of Black Diamond Therapeutics. “We look forward to the continued advancement of BDTX-189 through clinical development and remain on track to initiate the potentially pivotal Phase 2 portion of the MasterKey-01 trial in the second half of 2021.” “These initial data suggest BDTX-189 may provide meaningful clinical benefit to patients with advanced solid tumors, including those with allosteric EGFR and HER2 mutations,” said Alison Schram, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center. “The ...