Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage biopharmaceutical company specializing in the development of precision cancer medicines, today announced encouraging results from recent clinical trials involving its novel therapy, BDTX-1535. These results, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, showcased the drug’s effectiveness in patients with recurrent glioblastoma (GBM), as well as its safety profile which aligns with previous findings in non-small cell lung cancer (NSCLC).
BDTX-1535 is a fourth-generation covalent EGFR inhibitor designed to target a broad spectrum of EGFR alterations in cancer patients. The recent Phase 1 dose escalation trial demonstrated significant brain penetration and anti-tumor activity, particularly in patients with previously treated GBM. Patrick Wen, M.D., Director of The Center for Neuro-Oncology at Dana-Farber Cancer Institute, highlighted the therapy’s promising performance. “The Phase 1 dose escalation results show promising duration of treatment beyond the typical two to four months expected in the recurrent setting, along with good safety and tolerability at therapeutic doses,” he stated.
The trial involved increasing doses of BDTX-1535 given in 21-day cycles, focusing on safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity. As of January 20, 2024, the treatment was generally well tolerated with no grade 3 adverse events reported at doses ≤100 mg/day. Among 19 efficacy-evaluable patients, several achieved stable disease, with one confirmed partial response and eight instances of stable disease. Notably, five patients remained on treatment for at least four months, with one patient continuing beyond 16 months.
In addition to the Phase 1 trial, initial results from a Phase 0/1 “trigger” trial conducted at the Ivy Brain Tumor Center in Arizona were also promising. This investigator-sponsored trial tested BDTX-1535 in patients with recurrent high-grade glioma (HGG) who had EGFR alterations or fusions. Patients were dosed either with 200mg daily for five days or 400mg three times per week prior to brain tumor resection. The drug exceeded the pre-specified pharmacokinetic threshold in brain tumor tissue, suggesting effective drug delivery and activity at the site of the tumor.
Nader Sanai, M.D., Director of the Ivy Brain Tumor Center, commented on the results: “We are very pleased with these initial results showing that BDTX-1535 achieves levels in brain tumor tissue needed to observe a therapeutic effect. Clinical activity in these patients with further follow-up could support an additional trial of BDTX-1535 in newly diagnosed patients with confirmed EGFR mutations.”
The delayed stock performance of Black Diamond Therapeutics reflected the positive reception of these trial results, with shares closing at $6.10, up 19.37% at the close of trading on June 11, 2024. After hours, the stock saw a slight increase to $6.15, demonstrating continued investor confidence.
These developments represent a significant step forward for Black Diamond Therapeutics as it continues to advance its pipeline of MasterKey therapies, targeting oncogenic mutations to potentially deliver life-extending and quality-of-life-enhancing outcomes to cancer patients.
