Full Press Release Details
Therapeutics Announces Strategic Priorities and Expected Milestones for 2022
- Company announces IND submission for BDTX-1535 for the treatment of GBM and NSCLC
including those with CNS tumors;
- Company to enroll additional patients into MasterKey-01 Phase 1 safety expansion cohort to
obtain more clinical data and inform future development of BDTX-189;
- Company anticipates initiation of IND-enabling studies for its CNS-penetrant Class I,II,III BRAF
- Existing resources to be prioritized in the near-term for advancement of MasterKey pipeline
programs BDTX-1535, BRAF, FGFR and the MAP discovery engine; cash runway extended to 2024
And NEW YORK, January 10, 2022 (GLOBE NEWSWIRE) - Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine
company pioneering the discovery and development of MasterKey therapies, today announced a strategic pipeline update and outlined its
expected upcoming milestones.
inhibitors target mutation families and are designed to address the unmet medical need of cancer patients with genetically defined cancers
for whom precision therapies are not available," said David Epstein, Ph.D., Chief Executive Officer of Black Diamond Therapeutics.
"We are incredibly pleased to have submitted the IND ahead of schedule for BDTX-1535, a next generation CNS penetrant MasterKey
inhibitor designed to target EGFR driver mutations found in certain patients with GBM and NSCLC. The oncogenic alterations of EGFR, particularly
those associated with GBM, result in distinct conformations which impart unique pharmacology and drug resistance. BDTX-1535 is designed
to exploit this mechanism as a critical point of attack. We believe Black Diamond is uniquely positioned to deliver a pipeline of truly
differentiated MasterKey programs as we leverage our expertise in cancer genomics, onco-protein function and drug discovery."
of the rapid evolution of the treatment landscape in NSCLC harboring EGFR or HER2 Exon 20 insertion mutations, we have decided to obtain
further clinical data from the BDTX-189 safety expansion cohort at the recommended Phase 2 dose in 2022 in order to inform the future
development of our BDTX-189 program, gating the start of a Phase 2 trial. The revised strategy enables near-term prioritization of BDTX-1535
clinical development and further investment in our pipeline, while allowing us to obtain more clinical data on BDTX-189, and simultaneously
extends our cash runway into 2024."
Updates and Expected Milestones:
Black Diamond Therapeutics is a precision
oncology medicine company pioneering the development of novel MasterKey therapies. Black Diamond is addressing the significant unmet
need for novel precision oncology therapies for patients with genetically defined cancers who have limited treatment options. Black Diamond
is built upon a deep understanding of cancer genetics, onco-protein function, and drug discovery. 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 to predict
and validate oncogenic mutations that promote cancer across tumor types as MasterKey mutations. Black Diamond discovers and develops
selective MasterKey therapies against these families of oncogenic mutations. Black Diamond was founded by David M. Epstein, Ph.D., and
Elizabeth Buck, Ph.D. 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, including expectations for IND allowance and plans
for initiating the Phase 1 trial of BDTX-1535, the continuation of the BDTX-189 safety expansion cohort and the resulting data, the
continued development of the BRAF program, including the timing for initiating IND-enabling studies, the continued development of
the FGFR program, including plans for nominating a development candidate, the continued development of the MAP discovery engine and
the Company's cash runway. 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: the success, cost, and timing of the Company's product candidate
development activities and planned IND-enabling studies and clinical trials, the Company's ability to execute on its strategy,
regulatory developments in the United States, the Company's ability to fund operations, and the impact that the current
COVID-19 pandemic will have on the Company's clinical trials and preclinical studies, supply chain, and operations, as well as
those risks and uncertainties set forth in its Annual Report on Form 10-K for the year ended December 31, 2020, filed with the
United States Securities and Exchange Commission and in its other 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.