Core Insights - BDC-3042 demonstrated a favorable safety profile and biological activity in a Phase 1 clinical study, with no dose-limiting toxicities or serious adverse events reported [1][4][5] - The drug showed signs of anti-tumor activity, particularly in non-small cell lung cancer (NSCLC) patients, with 80% of evaluable patients achieving stable disease or better [1][4] - Bolt Biotherapeutics is seeking a partnership to accelerate the development and commercialization of BDC-3042, highlighting its significant commercial potential [2][6] Clinical Study Findings - The Phase 1 study enrolled 17 patients across seven dose cohorts, with a median of four prior lines of therapy [3] - The recommended Phase 2 dose (RP2D) was established at 10 mg/kg every two weeks, with further exploration of other doses and schedules planned [3] - Evidence of target engagement was confirmed, with 100% of patient samples showing detectable dectin-2 staining [4] Safety and Efficacy - BDC-3042 was well tolerated, with no grade 4 or 5 drug-related adverse events reported [4] - The most common drug-related adverse events included fatigue, flatulence, and nausea, each occurring in 12% of patients [4] - The study indicated that patients previously treated with PD-(L)1 inhibitors may have improved outcomes due to higher dectin-2 expression [3][5] Company Overview - Bolt Biotherapeutics is focused on developing novel immunotherapies for cancer treatment, with BDC-3042 being a first-in-class agonist antibody targeting dectin-2 [6] - The company is also advancing BDC-4182, a next-generation immune-stimulating antibody conjugate, with clinical trials expected to begin in the second quarter of 2025 [6]
Bolt Biotherapeutics Presents Results from the Phase 1 Dose-Escalation Clinical Study of BDC-3042 at AACR Annual Meeting 2025