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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 has reported promising initial Phase 2 data for BDTX-1535 in patients with recurrent EGFRm NSCLC. Key findings include:
- A 200 mg daily dose selected for pivotal development, showing a favorable tolerability profile
- Preliminary ORR of 42% in 19 patients at 200 mg with on-target resistance EGFR mutations
- Encouraging durability with DOR of approximately 8 months or more for the first 3 patients with a PR
- 14 of 19 patients remain on treatment
The company anticipates regulatory feedback on the registration path in Q1 2025 and expects initial results of BDTX-1535 in first-line NSCLC patients with non-classical EGFR mutations in the same quarter.
Black Diamond Therapeutics (Nasdaq: BDTX), a clinical-stage oncology company, has announced a webcast presentation of initial Phase 2 clinical trial results for BDTX-1535 in patients with recurrent EGFRm NSCLC. The webcast is scheduled for Monday, September 23, 2024, at 8:00 a.m. ET.
Black Diamond specializes in developing MasterKey therapies targeting families of oncogenic mutations in cancer patients. The presentation will be accessible under the 'Events and Presentations' section of the company's website, with a replay available after the event.
Black Diamond Therapeutics (Nasdaq: BDTX) presented real-world treatment outcomes for newly diagnosed NSCLC patients with non-classical EGFR mutations (NCMs) at the ESMO Congress 2024. The study analyzed 3,276 cases from Guardant Health's database, revealing that 60% of NCM patients received chemotherapy/immunotherapy, while 36% received osimertinib or afatinib. Patients with NCMs showed shorter treatment duration compared to those with classical mutations. BDTX-1535, Black Diamond's fourth-generation EGFR TKI, aims to address a broad spectrum of EGFR mutations, including NCMs. The company plans to disclose initial Phase 2 data for BDTX-1535 in Q1 2025 for first-line NCM treatment and release second/third-line results later this month.
Black Diamond Therapeutics (Nasdaq: BDTX) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Initial Phase 2 data of BDTX-1535 in 2L/3L EGFRm NSCLC patients expected in Q3 2024.
2. Phase 2 data of BDTX-1535 in 1L non-classical EGFRm NSCLC patients anticipated in Q1 2025.
3. Initial Phase 1 data of BDTX-4933 in KRASm NSCLC expected in Q4 2024.
4. Cash position of $123.0 million as of June 30, 2024, expected to fund operations into Q4 2025.
5. Q2 2024 net loss of $19.9 million, compared to $19.2 million in Q2 2023.
6. R&D expenses decreased to $12.6 million, while G&A expenses increased to $9.6 million in Q2 2024.
Black Diamond Therapeutics presented promising clinical data on its lead candidate BDTX-1535 at the 2024 ASCO Annual Meeting. The Phase 1 dose escalation trial in recurrent glioblastoma (GBM) patients showed a favorable safety profile and encouraging anti-tumor activity, with several patients achieving stable disease and one recording a partial response. Initial results from a Phase 0/1 “trigger” trial indicated that BDTX-1535 achieved clinically meaningful drug levels in brain tumor tissue. No serious adverse events were linked to BDTX-1535, and the drug was well-tolerated. Updates on the ongoing trials are expected later in 2024.
Black Diamond Therapeutics (Nasdaq: BDTX), a clinical-stage oncology company, announced that CEO Mark Velleca will participate in a fireside chat at the Jefferies Global Healthcare Conference in New York, NY. The event, focusing on the company's development of MasterKey therapies for oncogenic mutations in cancer patients, is scheduled for June 5, 2024, from 7:30-7:55am ET. The presentation will be available via live webcast on the company's investor relations website, with a replay accessible for 90 days post-event.
Black Diamond Therapeutics, a clinical-stage oncology company, reported financial results for Q1 2024. They are developing BDTX-1535 for NSCLC patients with EGFR mutations, presenting positive real-world evidence and upcoming poster presentations. The company's cash position was $115.2 million as of March 31, 2024, with plans to fund operations into Q3 2025.
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