Bolt Biotherapeutics Presents Updated Preclinical Data for BDC-4182 and Key Learnings from Phase 1 Dose-Escalation Trial of BDC-1001 at SITC 39th Annual Meeting

Core Insights - Bolt Biotherapeutics presented promising preclinical data for BDC-4182, a next-generation Boltbody™ ISAC targeting claudin 18.2, at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) [1][2] - BDC-4182 demonstrated superior efficacy compared to cytotoxic claudin 18.2 ADCs in syngeneic tumor models and showed potential to eradicate tumors with low claudin 18.2 expression [2] - The company anticipates initiating clinical trials for BDC-4182 in 2025, supported by strong in vitro and in vivo data [2][5] Preclinical Data - BDC-4182 exhibited compelling anti-tumor activity across various tumor models and elicited immunological memory [2] - The safety profile of BDC-4182 was acceptable in non-human primates, consistent with TLR7/8 activation and claudin 18.2 targeting [2] - The toxicology profile of BDC-4182 may allow for combinations with checkpoint inhibitors, chemotherapy, and anti-angiogenesis agents in treatment regimens [2] Phase 1 Trial Insights - The Phase 1 trial of BDC-1001 indicated that greater immune activation correlated with clinical benefits, particularly in patients with high HER2 antigen expression [3] - Pharmacodynamic changes were noted in HER2 IHC3+ and HER2 IHC2+ patients, with significant increases observed in HER2 IHC3+ tumors [3] - Findings from the BDC-1001 trial support the hypothesis that next-generation ISACs with enhanced immune activation could provide greater efficacy [3] Boltbody™ ISAC Program - The Boltbody™ ISAC platform combines tumor-targeting antibodies with immune stimulants to generate robust anti-cancer responses [4] - Each ISAC candidate is designed to activate myeloid cells, promoting a positive feedback loop that enhances the immune response in the tumor microenvironment [4] - The program aims to develop durable therapeutic responses for cancer patients through innovative immunotherapy approaches [4] Company Overview - Bolt Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies for cancer treatment [5] - The company's pipeline includes BDC-3042, an agonist antibody targeting Dectin-2, and BDC-4182, both of which are supported by extensive research in myeloid biology and cancer drug development [5] - Bolt Biotherapeutics is also engaged in strategic collaborations to advance its Boltbody ISAC candidates [5]