Tuesday, July 25, 2023
HanchorBio has received approval from the Taiwan Food and Drug Administration (TFDA) for its investigational new drug (IND) application, enabling them to proceed with a multi-regional clinical trial of their novel drug candidate, HCB101. This drug is being developed to treat patients with advanced solid tumours or relapsed and refractory non-Hodgkin lymphoma.
HCB101 is created using structure-guided protein design and engineering, along with relevant screening technologies. It consists of an engineered extracellular domain of SIRPα fused to the Fc region of IgG4.
This innovative drug works by triggering the phagocytic activity of macrophages, blocking the "do not eat" signal between macrophages and tumour cells. The extensive in-vitro and in-vivo preclinical data suggest that HCB101 could be a safer and more potent biologic compared to the anti-CD47 monoclonal antibodies and SIRPa fusion proteins currently under investigation in clinical trials.
The clinical trial, known as HCB101-101, will be a multi-regional, multi-centre, open-label, dose-finding, first-in-human (FIH) study involving adults with advanced solid tumours or relapsed and refractory non-Hodgkin lymphoma in both the United States and Taiwan. The primary objectives of this study are to assess the safety, tolerability, pharmacokinetics, and clinical anti-tumour activity of weekly HCB101 intravenous injections.