Black Diamond Therapeutics, Inc. is a precision oncology medicine company, which engages in discovery and development of small molecule, masterkey therapies. The company was founded by David M. Epstein and Elizabeth Buck in 2014 and is headquartered in Cambridge, MA.
相关临床试验
8
6 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2017
进行中（未招募）
5
62.5%
尚未招募
1
12.5%
招募中
1
12.5%
终止
1
12.5%
暂无批准数据
- Black Diamond Therapeutics reported 60% objective response rate and 86% CNS response rate for silevertinib in frontline non-classical EGFR-mutant NSCLC patients. - The company plans to initiate a randomized Phase 2 trial for silevertinib in newly diagnosed EGFR-altered glioblastoma in Q2 2026. - Updated clinical data including preliminary duration of response and progression-free survival data will be presented at a medical meeting in Q2 2026. - The company ended 2025 with $128.7 million in cash, sufficient to fund operations into the second half of 2028.
- Black Diamond Therapeutics will host a webcast on December 3, 2025, to present Phase 2 clinical trial results for silevertinib, a brain-penetrant fourth-generation EGFR inhibitor. - Silevertinib is being evaluated in a Phase 2 trial for non-small cell lung cancer patients with EGFR mutations and glioblastoma. - The company's MasterKey therapy approach is designed to target families of oncogenic mutations while overcoming resistance and minimizing toxicities. - The webcast will provide a comprehensive program update on this brain-penetrant EGFR MasterKey inhibitor targeting central nervous system disease.
- Black Diamond Therapeutics plans to disclose objective response rate and preliminary duration of treatment data from 43 patients in its Phase 2 trial of silevertinib for frontline non-classical EGFR-mutant NSCLC later this quarter. - The company reported $135.5 million in cash reserves as of September 30, 2025, sufficient to fund operations into Q4 2027, while reducing R&D expenses by 43% year-over-year to $7.4 million. - Progression-free survival data is expected in the first half of 2026, when the company intends to seek FDA feedback on a potential registrational pathway for frontline EGFR-mutant NSCLC. - Black Diamond continues exploring partnership opportunities for silevertinib in both NSCLC and glioblastoma to advance the brain-penetrant fourth-generation EGFR inhibitor into pivotal development.
- Black Diamond Therapeutics has completed enrollment in its mid-stage study of silevertinib, a fourth-generation EGFR inhibitor targeting non-classical EGFR mutations in frontline NSCLC patients. - The company plans to disclose objective response rate and duration of response data from all 43 patients in Q4 2025, with FDA feedback on a potential registrational path expected in H1 2026. - Silevertinib faces significant competition in the NSCLC space, particularly from Johnson & Johnson's recently approved Rybrevant plus Lazcluze combination and AstraZeneca's established Tagrisso therapy. - Following the outlicensing of BDTX-4933 to Servier Pharmaceuticals, Black Diamond is now solely focused on silevertinib development and actively seeking strategic partners for advancement.
- Major pharmaceutical and biotech companies including Pfizer, Johnson & Johnson, Fate Therapeutics, and Generation Bio are implementing workforce reductions as part of industry-wide financial restructuring efforts. - Companies are shifting from broad R&D portfolios to focused pipeline optimization, with firms like Shattuck Labs and Relay Therapeutics narrowing their therapeutic focus to core projects with highest potential returns. - The layoffs reflect strategic responses to investor pressure for capital discipline, post-pandemic demand shifts, and the need to extend cash reserves while maintaining progress on lead clinical programs. - Industry consolidation and increased outsourcing to contract research organizations are driving operational realignment, as companies seek to reduce overhead costs and access specialized expertise without maintaining high-cost facilities.
• Servier has secured global rights to develop and commercialize BDTX-4933, a Phase 1 targeted therapy designed to address both RAS mutations and RAF alterations in solid tumors, particularly non-small cell lung cancer. • The agreement includes a $70 million upfront payment to Black Diamond Therapeutics, with potential for up to $710 million in additional milestone payments plus tiered royalties on global sales. • BDTX-4933 is currently in Phase 1 trials evaluating safety, dosing, and efficacy in patients with advanced cancers harboring BRAF, CRAF, or NRAS mutations, positioning it as a potential best-in-class treatment for RAF/RAS-mutant solid tumors.
• New therapeutic approaches, including small molecules, cell therapies, and vaccines, are revitalizing glioblastoma research after 20 years of limited progress. • Merck's acquisition of Modifi Biosciences and Kazia Therapeutics' paxalisib are leading the charge with innovative small molecule therapies targeting DNA repair and PI3K pathways, respectively. • CAR T-cell therapies targeting EGFR and interleukin-13 receptor alpha 2, along with vaccines like SurVaxM, are showing early promise in shrinking tumors and improving survival. • The glioblastoma market is projected to grow to $5.7 billion by 2033, driven by targeted therapies and immunotherapies, signaling increased investment and innovation in the field.
• BDTX-1535, a fourth-generation EGFR TKI, demonstrates encouraging clinical activity in relapsed/refractory EGFR-mutant non-small cell lung cancer (NSCLC). • A phase 2 trial showed a 42% objective response rate (ORR) in patients with osimertinib-resistant EGFR mutations, including C797S. • The 200 mg daily dose of BDTX-1535 was well-tolerated, with mostly mild to moderate adverse events and no new safety signals observed. • Black Diamond Therapeutics anticipates sharing initial results from the first-line cohort in Q1 2025 and discussing potential registration paths.
• Daiichi Sankyo and AstraZeneca's Dato-DXd failed to improve overall survival in the TROPION-Breast01 trial, despite earlier reports of delaying tumor progression in certain breast cancers. • Black Diamond Therapeutics reported a 42% tumor response rate for BDTX-1535 in EGFR-mutated non-small cell lung cancer resistant to Tagrisso. • Biohaven's troriluzole met its primary endpoint in a Phase 3 trial for spinocerebellar ataxia, with plans for FDA submission after a previous rejection.
• Black Diamond Therapeutics will present initial Phase 2 clinical trial results for BDTX-1535 in recurrent EGFRm NSCLC. • The webcast presentation is scheduled for Monday, September 23, 2024, at 8:00 a.m. ET. • BDTX-1535 is a brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR mutant NSCLC and GBM. • Black Diamond's MasterKey therapies target families of oncogenic mutations, aiming to overcome resistance and minimize toxicities.
