HanchorBio Secures FDA Clearance for Trispecific Cancer Therapy HCB303

Engineered via the company’s proprietary FBDB platform, HCB303 represents a departure from traditional anti-TIGIT antibody approaches. While conventional therapies primarily block TIGIT receptor signaling, this fusion protein is designed to intercept TIGIT ligands, such as PVR and CD112. By trapping these ligands, the molecule aims to reduce inhibitory signaling while preserving the CD226 activating axis, which is critical for robust T and NK cell performance.

Beyond its TIGIT-focused strategy, the therapy simultaneously targets the PD-L1 and CD47 pathways to coordinate both innate and adaptive immune responses. Scott Liu, founder and chairman of HanchorBio, stated that the architecture is designed to address the down-regulation of CD226, which he argues is a limitation of standard PVR signaling blockade. The upcoming HCB303-ONC-101 study will assess the safety, pharmacokinetics, and preliminary antitumor efficacy of the drug in patients who have exhausted standard treatment options. This marks the second trispecific program from HanchorBio to enter clinical development, following the progression of its HCB301 candidate.