Taiwan-based HanchorBio has announced receiving the green light from the US FDA to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101. The non-blind, dose exploration first-in-human trial will be conducted in the US and Taiwan, focusing on assessing the safety, tolerability, pharmacokinetics, and preliminary clinical anti-tumor efficacy of HCB101 in patients with advanced solid tumors or relapsed refractory non-Hodgkin’s lymphoma. An Investigational New Drug (IND) filing for HCB101 in Taiwan is currently under review.
HCB101’s Mechanism and Preclinical Data
HCB101 is an engineered SIRP linked to IgG4-Fc α fusion proteins, designed to block the escape mechanism of tumor cells and trigger the phagocytic activity of macrophages towards tumor cells. Preclinical data indicate that HCB101 is expected to be more efficacious and safer than CD47 monoclonal antibodies or SIRP α fusion proteins. Quantitative RNA transcription analysis has shown that HCB101 induces significantly different gene expression in tumor cells and the microenvironment, suggesting a unique mechanism of action that could set it apart in the field of oncology.-Fineline Info & Tech
