HCB303 / HanchorBio - LARVOL DELTA

HanchorBio…announced that its wholly owned subsidiary, FBD Biologics Limited, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for HCB303 (HanchorBio Press Release) - "The submission follows pre-IND written feedback received from the FDA in early August 2026. HanchorBio incorporated the Agency’s recommendations-including a dose-limiting toxicity framework, safety monitoring, clinical pharmacology, and a dosage-optimization strategy aligned with the FDA’s Project Optimus principles-into the final IND package. The planned Phase 1 first-in-human study will evaluate HCB303 in adults with advanced, relapsed, or refractory solid tumors with no remaining standard treatment options."

IND • New P1 trial • Solid Tumor

HanchorBio Prepares HCB303 Multi-Target Immunotherapy for IND Filing (HanchorBio Press Release) - "HCB303 is a novel fusion protein designed to simultaneously target multiple major immunosuppressive pathways, including PD-L1/PD-1, SIRPα/CD47, and others....In in vitro studies, HCB303 exhibited superior binding and blocking capabilities at its intended targets....In in vivo animal models, HCB303 demonstrated robust tumor inhibition in both human PBMC/tumor co-mixed xenograft model and hTIGIT/hCD47 transgenic mouse model. Treatment with HCB303 led to increased activation of immune cells and a higher proportion of tumor-infiltrating lymphocytes (TILs), supporting its efficacy through multiple immune-modulatory mechanisms....HCB303 is currently in the process development phase, with an IND submission targeted for completion by 2026."

IND • Preclinical • Oncology