Taiwan-based HanchorBio has announced that it has received approval from the Taiwan Food and Drug Administration (WFDA) to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101.
HCB101: A Promising Fusion Protein for Cancer Treatment
HCB101 is an engineered SIRP linked to IgG4-Fc α fusion proteins that can 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, making it a potentially significant advancement in cancer treatment.
Design and Expectations of the HCB101-101 Study
The HCB101-101 study is a multi-region, multi-center, non-blind, dosage exploration first-in-human (FIH) study designed to assess the safety, tolerability, pharmacokinetics, and preliminary clinical anti-tumor efficacy in advanced solid tumors or recurrent refractory non-Hodgkin lymphoma. The study is expected to commence during the third quarter of 2023 in the US, following its approval in April this year.
Global Development of SIRPα Fusion Proteins
Meanwhile, in China, other SIRPα fusion proteins are under development, including CSPC Pharmaceutical’s JMT601 (under fast-track review in the US), ImmuneOnco’s IMM01, and Sumgen Biotech’s SG404. These developments highlight the global interest and progress in this therapeutic area.-Fineline Info & Tech
