- Bolt Biotherapeutics (BOLT, Financial) reports positive Phase 1 trial results for BDC-3042 at AACR 2025.
- BDC-3042 was well-tolerated with no serious adverse events, and 80% of patients achieved stable disease or better.
- Company seeks partnership opportunities to advance development, focusing on NSCLC and post-immunotherapy settings.
Bolt Biotherapeutics (BOLT) announced encouraging results from its Phase 1 dose-escalation study of BDC-3042, a novel immunotherapy for cancer treatment, presented at the AACR Annual Meeting 2025. The study was conducted on 17 patients across seven dose cohorts with varied tumor types, demonstrating significant promise in both safety and preliminary efficacy.
Key findings from the trial include the tolerability of BDC-3042 up to 10 mg/kg every two weeks, with no dose-limiting toxicities observed and the absence of serious adverse events. The most common treatment-related adverse effects were mild, including fatigue, flatulence, and nausea, each reported by 12% of participants. Notably, the therapy showed favorable pharmacokinetics and biological activity, providing a robust foundation for further development.
The study revealed compelling anti-tumor activity, particularly in non-small cell lung cancer (NSCLC) patients. An unconfirmed partial response was noted, and all three NSCLC patients in the study exhibited stable disease or better outcomes. Additionally, 80% of evaluable patients achieved stable disease or better as their best response, indicating the potential efficacy of BDC-3042.
Moving forward, Bolt Biotherapeutics is actively seeking partnerships to further the development of BDC-3042, particularly enhancing its application in NSCLC and post-immunotherapy settings. The company emphasizes the drug's potential in treating patients who have previously received PD-1/PD-L1 therapies, offering a new avenue for those with limited options.
The company highlighted the need for collaborations to propel the clinical development and eventual commercialization of BDC-3042, focusing on its combination possibilities with other cancer treatments and the significant commercial opportunity this presents.
