CEA ISAC / Bolt Biotherapeutics - LARVOL DELTA

Preclinical evaluation of a highly efficacious next-generation CEACAM5 (CEA) ISAC comprising a novel CEA-specific mAb and TLR7/8 agonist (SITC 2025) - "The new CEA ISAC is active in human, non-human primate and mouse systems and has several advantages over reference CEA antibodies such as tusamitamab and labetuzumab.Results Our novel CEA mAb, P601 binds with high affinity and selectivity to human and cynomolgus CEA+ cells. The CEA ISAC compares favorably to other CEA-targeted modalities and inhibited tumor growth at lower doses than cytotoxic ADCs. Finally, in a non-GLP NHP toxicology study the next-generation CEA ISAC was well-tolerated with no significant drug-related adverse events observed up to 15 mg/kg, the highest dose tested.Conclusions These pre-clinical data demonstrate induction of a robust innate and adaptive immune response by our next-generation CEA-targeted ISAC and the potential to treat CEACAM5+ human cancers."

Preclinical • Oncology • CEACAM5 • TLR7

Bolt Biotherapeutics Presents Preclinical Results for Next-Generation Boltbody ISACs targeting CEA…at AACR Annual Meeting 2025 (GlobeNewswire) - "Key results with the next-gen CEA ISAC are below: Antigen-dependent induction of immune-stimulating cytokines in human, NHP and mouse effector cells. Complete responses in CEA transgenic syngeneic model demonstrates robust efficacy. Induction of immunological memory demonstrates potential for durable responses. In a non-GLP NHP tox study, the next-generation CEA ISAC was well-tolerated with no significant drug-related adverse events observed up to 15 mg/kg, the highest tested dose."

Preclinical • Solid Tumor

A highly efficacious next-generation CEACAM5 (CEA)-targeted Boltbody™ ISAC for the treatment of colorectal, pancreatic and lung tumors (AACR 2025) - "This pre-clinical data set demonstrates the antigen-dependent induction of a robust innate and adaptive immune response by a next-generation CEA-targeted ISAC and the potential to treat CEACAM5+ human cancers."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • IFNG • TNFA

Bolt Biotherapeutics to Present Data from Phase 1 Dose-Escalation Clinical Study of BDC-3042 at AACR Annual Meeting 2025 (GlobeNewswire) - "Bolt Biotherapeutics...announced it will present data from the Phase 1 dose-escalation clinical study of BDC-3042 in patients with advanced cancers at the American Association for Cancer Research (AACR) Annual Meeting....BDC-3042 is a proprietary agonist antibody that targets dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable solid tumors including non-small cell lung cancer (NSCLC). Bolt will also be presenting preclinical data from two of its pipeline programs, Boltbody ISACs targeting CEA and PD-L1."

P1 data • Preclinical • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer