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CAMBRIDGE, Mass and NEW YORK, April 17, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, today announced the presentation of three posters highlighting the design of the phase 1 clinical study of BDTX-1535 and new preclinical data on BDTX-1535 and BDTX-4933 at the 2023 American Association of Cancer Research (AACR) Annual Meeting being held in Orlando, Florida.
“Black Diamond’s MasterKey approach to precision oncology medicines is grounded in our deep understanding of the characterization of oncogenic mutations, and these presentations highlight the depth of our work to expand the addressable patient population for precision oncology. With an everchanging treatment landscape for genetically defined cancers, we believe that our approach to grouping our targets into druggable oncogene families presents a truly differentiated opportunity to address the continuing unmet need of patients,” said Elizabeth Buck, Ph.D., Chief Scientific Officer of Black Diamond. “Our MAP Drug Discovery Engine has enabled us to intricately design MasterKey inhibitors based on extensive preclinical and real-world data, elucidating what we believe to be the necessary attributes for effectively targeting shared, activated conformations used by oncogenic drivers for tumor growth. Our fourth-generation irreversible brain penetrant EGFR MasterKey inhibitor, BDTX-1535, has demonstrated its ability to achieve potent anti-tumor activity against EGFR alterations and amplifications in a broad range of preclinical NSCLC and GBM models and we look forward to continuing to advance its development in the clinic and providing a first clinical update in the second half of this year. Our next most advanced program, BDTX-4933 was designed to be brain penetrant and selectively inhibits aberrant RAF signaling as result of BRAF class I, II, III and RAS oncogenic mutations without inducing paradoxical activation. We are encouraged by the results shared today, which support its potentially best-in-class profile.”
BDTX-1535 Program:
Black Diamond presented two posters highlighting BDTX-1535’s preclinical development as well as the ongoing Phase 1 study.
In a poster titled, “Discovery of BDTX-1535, a novel brain penetrant, irreversible, potent, wild type sparing EGFR MasterKey inhibitor that targets oncogenic kinase domain mutations as well as extracellular domain alterations for the treatment of NSCLC and GBM,” Black Diamond outlined the unmet need for next generation EGFR inhibitors that target classical driver mutations as well as acquired and intrinsic resistance mutations expressed in the context of EGFR driver mutations in non-small cell lung cancer (NSCLC), and EGFR alterations expressed in glioblastoma multiforme (GBM). Additional highlights include:
In a poster titled, “A Phase 1 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients with Glioblastoma or Non-Small Cell Lung Cancer,” Black Diamond outlined its ongoing Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics, CNS penetrance and preliminary antitumor activity of BDTX-1535 in recurrent GBM (rGBM) or locally advanced or metastatic NSCLC with or without CNS disease. Key highlights include:
Black Diamond remains on track to provide a clinical update on BDTX-1535 in the second half of 2023.
BDTX-4933 Program:
In a poster titled, “Preclinical characterization of a brain penetrant RAF inhibitor, BDTX-4933, targeting oncogenic BRAF Class I/II/III and RAS mutation,” Black Diamond outlined its approach to characterizing BRAF, RAS and MAPK pathway in addition to the design and preclinical development of BDTX-4933:
Black Diamond expects to initiate a Phase 1 clinical trial of BDTX-4933 in patients with tumors harboring all-class BRAF or RAS mutations in the second quarter of 2023.
The posters from the AACR Annual Meeting are available on the “Scientific Presentations and Publications” section of the Black Diamond Therapeutics website.
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage precision oncology medicine company focused on the development of MasterKey therapies that target families of oncogenic mutations in clinically validated targets. Black Diamond leverages a deep understanding of cancer genetics and onco-protein structure and function, to discover and develop innovative MasterKey therapies. The Company’s MasterKey therapies are designed to overcome resistance, minimize on-target, wild-type mediated toxicities, and be brain-penetrant to address significant unmet medical needs of patients with genetically defined cancers. The Company is advancing a robust pipeline with lead clinical-stage program BDTX-1535, targeting MasterKey mutations in both EGFR mutant-positive non-small cell lung cancer (NSCLC) and in glioblastoma multiforme (GBM), and BDTX-4933, a program targeting RAF MasterKey mutations in solid tumors, as well as discovery-stage research programs. The Company’s proprietary Mutation-Allostery-Pharmacology, or MAP drug discovery engine, is designed to allow Black Diamond to analyze population-level genetic sequencing tumor data and validate MasterKey mutations. For more information, please visit www.blackdiamondtherapeutics.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the continued development and advancement of BDTX-1535 and BDTX-4933, including the ongoing Phase 1 clinical trial and the expected timing for data updates for BDTX-1535 and the timing for initiating a Phase I clinical trial of BDTX-4933. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the United States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contact:
Julie Seidel, Stern Investor Relations
(212) 362-1200