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Black Diamond Therapeutics, Inc. (Nasdaq: BDTX) is a leading precision oncology medicine company headquartered in Cambridge, Massachusetts. Founded in 2014, the company focuses on the discovery and development of small molecule, tumor-agnostic therapies designed to target families of oncogenic mutations across various cancers.
The core of Black Diamond’s innovative approach lies in its proprietary Mutation-Allostery-Pharmacology (MAP) platform. This platform enables the identification and targeting of allosteric mutations in key cancer-related kinases, offering new therapeutic options for patients with limited treatments available.
The company’s lead product candidate, BDTX-189, is a potent inhibitor targeting non-canonical and oncogenic mutations of ERBB kinases, including the epidermal growth factor receptor (EGFR) and tyrosine-protein kinase. The development pipeline also includes BDTX-1535, an advanced fourth-generation EGFR inhibitor, and BDTX-4933, targeting KRAS, NRAS, and BRAF mutations in solid tumors.
Recent clinical updates highlight the potential of BDTX-1535 in treating non-small cell lung cancer (NSCLC) and glioblastoma (GBM), demonstrating efficacy against over 50 clinically relevant non-classical EGFR mutations and resistance mutations like C797S. This candidate is currently advancing through Phase 2 trials, with promising results expected in 2024.
Black Diamond Therapeutics has also established significant collaborations and partnerships to bolster its research and development efforts. These collaborations aim to enhance the understanding of mutation landscapes and accelerate the delivery of new therapies to patients.
For more information, visit Black Diamond Therapeutics.
Black Diamond Therapeutics (BDTX) announced the appointment of Wendy L. Dixon, Ph.D., to its Board of Directors following the resignation of Brad Bolzon, Ph.D. This change aims to bolster the company's leadership as it advances its MasterKey therapies. Dr. Dixon, with over 40 years of experience in the biopharmaceutical industry and a strong background in marketing and drug development, is expected to enhance strategic initiatives, particularly in the ongoing clinical development of BDTX-1535 for glioblastoma multiforme. Dr. Epstein praised Bolzon's contributions during his tenure.
Black Diamond Therapeutics (BDTX) reported significant developments, including the initiation of a Phase 1 study for BDTX-1535, targeting glioblastoma and non-small cell lung cancer, after receiving FDA IND approval. As of December 31, 2021, the company held $209.8 million in cash, sufficient for operations into 2024. R&D expenses nearly doubled to $96.8 million due to increased headcount and clinical activities. The net loss for the year was $125.6 million, up from $67.3 million in 2020. Elizabeth Montgomery was appointed Chief People Officer, enhancing HR leadership in the company.
Black Diamond Therapeutics (Nasdaq: BDTX) announces participation in the Cowen 42nd Annual Health Care Conference. Its CEO, David M. Epstein, Ph.D., will join a panel on lung cancer on March 9, 2022, at 9:10 a.m. ET. A live webcast of the discussion will be available on the company’s website, with a replay accessible for 30 days. Black Diamond is focused on developing novel MasterKey therapies for patients with genetically defined cancers, leveraging its MAP drug discovery engine to target oncogenic mutations.
Black Diamond Therapeutics (Nasdaq: BDTX) has appointed Elizabeth Montgomery as its first Chief People Officer. With nearly 20 years of HR leadership experience in the life sciences industry, Montgomery will play a vital role in shaping the company's people and talent strategy. Her previous role at ClearView Healthcare Partners saw significant growth and expansion. Montgomery expressed her enthusiasm for Black Diamond's mission to enhance precision cancer therapies, promising to foster an inclusive workplace culture that encourages creativity and growth.
Black Diamond Therapeutics (Nasdaq: BDTX) announced that the FDA has cleared its investigational new drug (IND) application for BDTX-1535, a targeted therapy for oncogenic mutations in glioblastoma multiforme (GBM) and non-small cell lung cancer (NSCLC). The Phase 1 study is set to start in Q1 2022, with a clinical update expected in H2 2023. BDTX-1535 aims to meet the needs of over 60,000 GBM patients and 20,000 NSCLC patients annually in major markets, showing promising preclinical results in tumor regression without affecting body weight.
Black Diamond Therapeutics (BDTX) announced the submission of an IND for BDTX-1535, targeting EGFR mutations in glioblastoma multiforme (GBM) and non-small cell lung cancer (NSCLC). The company will expand patient enrollment in the MasterKey-01 Phase 1 study for BDTX-189 to gather more data. Black Diamond aims to initiate IND-enabling studies for a CNS-penetrant BRAF program in 2022, while focusing resources on its pipeline and extending its cash runway into 2024. A clinical data update for BDTX-1535 is expected in the second half of 2023.
Black Diamond Therapeutics (Nasdaq: BDTX) announced that its CEO, David M. Epstein, Ph.D., will present an update on the company's progress at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 9:00 a.m. ET. The presentation will be available via a live webcast through the investor relations section of the company's website, with a replay accessible for 30 days after.
This Cambridge-based company focuses on developing MasterKey therapies targeting undrugged mutations in genetically defined cancers.
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a company specializing in precision oncology, announced that CEO David M. Epstein, Ph.D., will present updates on the company's progress at two upcoming investor conferences. The first presentation is at the Stifel 2021 Virtual Healthcare Conference on November 15, 2021, at 4:40 PM ET. The second will be available on-demand at the Jefferies London Healthcare Conference starting November 18, 2021. Webcasts of the presentations will be accessible on the company's investor relations website.
Black Diamond Therapeutics reported financial results for Q3 2021, with cash reserves of $235 million. The company is preparing for the Phase 2 portion of the MasterKey-01 study for BDTX-189 and anticipates an IND filing for BDTX-1535 in H1 2022. Notable pre-clinical data for both programs were showcased at the ANE International Conference. R&D expenses rose to $27.6 million, while general and administrative expenses increased to $7.7 million, influenced by headcount growth and related costs.
Black Diamond Therapeutics (Nasdaq: BDTX) presented preclinical data for three early-stage pipeline programs at the AACR-NCI-EORTC Conference. The data highlights BDTX-1535's potential to address unmet needs in NSCLC patients with resistant mutations. This brain-penetrant inhibitor showed significant tumor growth inhibition in preclinical models and is on track for an IND filing in early 2022. The BRAF and FGFR programs also demonstrated innovative approaches targeting oncogenic mutations without the adverse effects seen with standard therapies, with IND filings anticipated in 2022.
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