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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 pre-clinical data presentation for three pipeline programs at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics scheduled from October 7-10, 2021. Notably, the oral presentation will highlight BDTX-1535, a CNS-penetrant inhibitor targeting resistant EGFR mutations, with potential implications for treating osimertinib-resistant non-small cell lung cancer. The company's innovative Mutation-Allostery-Pharmacology platform aims to discover therapies targeting oncogenic mutations in genetically defined cancers.
Black Diamond Therapeutics, a leader in precision oncology, announced its CEO, David M. Epstein, will present a corporate update at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference on September 28, 2021, at 4:40 PM ET. This presentation is significant for shareholders and interested parties as it highlights the company's advancements in developing MasterKey therapies targeting undrugged mutations in genetically defined cancers. A live webcast will be available on their website with a replay accessible for three weeks.
Black Diamond Therapeutics and OpenEye Scientific have announced a strategic partnership aimed at enhancing drug discovery through the integration of OpenEye's Orion molecular design platform with Black Diamond's proprietary MAP drug discovery engine. This collaboration will facilitate rapid simulations and analysis of protein dynamics, accelerating the development of MasterKey inhibitors targeting oncogenic mutations. The partnership includes an upfront payment and future financial arrangements based on product success. This initiative highlights the integration of computational and genomic strategies in cancer therapeutics.
Black Diamond Therapeutics (BDTX) reported second-quarter results with a cash balance of $263.5 million as of June 30, 2021, aimed to sustain operations into 2023. The company is set to commence the Phase 2 trial of BDTX-189 in the latter half of 2021 following positive initial Phase 1 data, indicating tolerability and preliminary anti-cancer activity. Additionally, BDTX-1535 is on schedule for Investigational New Drug (IND) filing in 2022. The company also witnessed a rise in R&D expenses to $26.7 million due to increased operational activities.
Black Diamond Therapeutics (BDTX) announced the appointment of Mark A. Velleca, M.D., Ph.D., to its Board of Directors. With over 20 years of experience in biotechnology, particularly in oncology, Dr. Velleca previously served as CEO of G1 Therapeutics. He is expected to enhance the company's strategic direction in precision medicine for genetically defined cancers. The leadership change aims to strengthen Black Diamond’s capabilities in drug development as it continues advancing its MasterKey therapies targeting specific oncogenic mutations.
Black Diamond Therapeutics (Nasdaq: BDTX) announced that its CEO, David M. Epstein, Ph.D., will speak at two upcoming investor conferences. The first is the 2021 Wedbush PacGrow Healthcare Conference on August 11, 2021, at 10:20 AM ET, where he will participate in a Targeted Oncology panel. The second event is the Canaccord Genuity 41st Annual Growth Conference, scheduled for August 12, 2021, at 1:00 PM ET. Webcasts of the presentations will be available on the company's website, along with replays for three weeks.
Black Diamond Therapeutics announced initial results from the Phase 1 dose-escalation study of BDTX-189 targeting advanced solid tumors with specific oncogenic alterations. The drug demonstrated a favorable safety profile, with manageable toxicities and pharmacokinetics aligning with preclinical data. Preliminary anti-cancer activity was noted in heavily pre-treated patients, including confirmed partial responses. The preliminary recommended Phase 2 dose is set at 800 mg once-daily. Further clinical development is planned, with data to be presented at the upcoming ASCO Annual Meeting.
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.
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