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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 (Nasdaq: BDTX) announced a webcast presentation on May 19, 2021, to discuss pharmacokinetic, safety, and preliminary efficacy data from the Phase 1 dose-escalation portion of the MasterKey-01 trial for BDTX-189, targeting advanced solid tumors. Key data will also be presented at the ASCO Annual Meeting on June 4, 2021. BDTX-189 is designed to inhibit oncogenic mutations of EGFR and HER2, with Fast Track designation from the FDA, highlighting its potential significance for patients with limited treatment options.
Black Diamond Therapeutics reported Q1 2021 results, highlighting progress in its clinical pipeline. The Phase 1/2 trial of BDTX-189 is on track, with over 50 patients dosed, aiming for initial data presentation at ASCO. The pre-clinical data for BDTX-1535 showed promising results in glioblastoma. Financially, the company held $290.1 million in cash, expected to fund operations until 2023, but R&D expenses surged to $22.8 million, up from $7.4 million in Q1 2020. General expenses also rose to $7.9 million from $5.5 million.
Black Diamond Therapeutics announced the presentation of initial pharmacokinetic, safety, and efficacy data from Phase 1 of the MasterKey-01 trial for BDTX-189.
The data will be showcased at the 2021 ASCO Annual Meeting, scheduled for June 4-8, 2021. BDTX-189 targets advanced solid tumors with oncogenic mutations of ErbB receptors.
The trial aims to determine recommended doses while evaluating its potential benefits for patients with limited treatment options. The FDA has granted Fast Track designation for this indication.
Black Diamond Therapeutics (BDTX) announced preclinical data on its therapies BDTX-189 and BDTX-1535 at the AACR Annual Meeting. BDTX-189 demonstrates a rapid and sustained target inhibition profile, with a predicted effective human dose of 400–800 mg QD. The Phase 1 MasterKey-01 trial is ongoing. Meanwhile, BDTX-1535 shows potent inhibition of EGFR variants in glioblastoma and non-small cell lung cancer. An IND application for BDTX-1535 is anticipated in H1 2022, reinforcing BDTX’s commitment to developing therapies targeting genetically defined cancers.
Black Diamond Therapeutics (Nasdaq: BDTX) announced key progress in its clinical trials and financial results for 2020. The Phase 1/2 trial of BDTX-189 is on schedule, with over 50 patients enrolled and preliminary data expected in the first half of 2021. The company anticipates starting the Phase 2 portion later this year. Cash reserves stood at $315.1 million, expected to fund operations into 2023. However, the FDA imposed a partial clinical hold on the Phase 2 enrollment due to regulatory requirements, but this will not hinder the ongoing Phase 1 study.
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX) announced the presentation of pre-clinical data on BDTX-189 and BDTX-1535 at the upcoming AACR Virtual Annual Meeting from April 10-15, 2021. Notable sessions include:
- BDTX-189: Estimating clinical pharmacokinetics and doses, April 10, 8:30 AM ET.
- BDTX-1535: Efficacy in patient-derived xenograft models, April 10, 8:30 AM ET.
BDTX-189 is an innovative inhibitor targeting a range of oncogenic proteins, aiming to improve toxicity profiles compared to current therapies.
Black Diamond Therapeutics (Nasdaq: BDTX) presented pre-clinical data on its BRAF and FGFR programs at the ESMO TAT Virtual Congress 2021. The BRAF program targets non-canonical mutations and aims to prevent paradoxical activation, indicating potential anti-tumor efficacy. The FGFR program focuses on sparing FGFR1 to reduce toxicity, showing activity against FGFR2/3 mutations. Both programs plan to file Investigational New Drug (IND) applications in 2022. These studies underscore Black Diamond's commitment to addressing unmet needs in oncology.
Black Diamond Therapeutics (Nasdaq: BDTX) announced that its CEO, David M. Epstein, Ph.D., will present company updates at several upcoming investor conferences. Notable events include: the Cowen 41st Annual Virtual Health Care Conference on March 2, 2021, the H.C. Wainwright Virtual Global Life Sciences Conference starting March 9, 2021, and the 10th Annual J.P. Morgan Napa Valley Forum on March 31, 2021. Live webcasts and replays of these presentations will be available on the company's investor relations website.
Black Diamond Therapeutics announced that its CEO, David M. Epstein, will present at the BMO Biopharma Spotlight Series on February 18, 2021, at 11:50 AM ET. The focus will be on innovative protein technologies. The presentation can be accessed via a live webcast on the company's investor relations page, with a replay available for three weeks. Black Diamond is known for pioneering tumor-agnostic therapies targeting genetically defined cancers using their unique MAP platform, which identifies oncogenic mutations across tumor types.
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX) has appointed Dr. Kapil Dhingra to its Board of Directors, enhancing its oncology expertise. Dr. Dhingra, with over 30 years in drug development, previously led key oncology projects at Roche. His insights are expected to be crucial for advancing the company’s candidate therapies, including BDTX-189 and BDTX-1535. The company aims to innovate in precision oncology targeting undrugged mutations to benefit patients with genetically defined cancers.
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