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Black Diamond Therapeutics reports clinical and corporate developments for a clinical-stage oncology business built around MasterKey therapies that target families of oncogenic mutations in cancer. Company news centers on silevertinib, a brain-penetrant fourth-generation EGFR MasterKey inhibitor, and its development in EGFR-mutant non-small cell lung cancer and glioblastoma.
Recurring updates include Phase 2 clinical data, medical meeting presentations, program expansion across NSCLC and GBM, financial results, cash runway commentary, partnership discussions and investor-conference participation. The company also describes its approach to genetically defined tumors, resistance mechanisms, wild-type mediated toxicities and central nervous system disease in program communications.
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.
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX) has announced that its President and CEO, David M. Epstein, Ph.D., will present an update on the company's progress at the J.P. Morgan 39th Annual Virtual Healthcare Conference. The presentation is scheduled for January 12, 2021, at 7:30 AM ET. A live webcast will be available on the company's investor relations website, with a replay lasting three weeks. Black Diamond focuses on precision oncology, targeting undrugged mutations in genetically defined cancers via its MAP platform.
Black Diamond Therapeutics, a precision oncology medicine company, announced that its CEO, David M. Epstein, will present an update on the company's advancements at the Piper Sandler 32nd Annual Virtual Healthcare Conference from December 1-3, 2020. The presentation will be available via webcast starting at the conference's beginning and archived for three weeks on the company’s investor relations website. Black Diamond integrates its proprietary Mutation-Allostery-Pharmacology platform to discover small molecule therapies targeting genetically defined cancers.
Black Diamond Therapeutics (Nasdaq: BDTX) has nominated BDTX-1535 as a development candidate for treating glioblastoma multiforme (GBM), initiating IND-enabling studies. Pre-clinical data presented at the 2020 Society for Neuro-Oncology Annual Meeting shows that BDTX-1535 effectively inhibits various oncogenic EGFR mutations linked to GBM and can penetrate the blood-brain barrier. These findings support BDTX-1535's potential to transform GBM treatment, marking a significant step in Black Diamond's commitment to innovative cancer therapies.