HanchorBio Announces First Patient Dosed in the Phase 1 Multi-Regional Clinical Trial of HCB101

HanchorBio Inc., a global clinical-stage biotechnology company focusing on the discovery and development of innovative immuno-biomedicines to treat a wide variety of patients suffering from different solid tumors or hematological malignancies with significant unmet medical needs, today announced that the first patient has been dosed in a Phase 1, multi-regional, multi-center clinical trial (ClinicalTrials.gov ID: NCT05892718). The trial aims to evaluate the safety, tolerability, pharmacodynamics, and anti-tumor activity of HCB101 in patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.

"The dosing of the first patient with HCB101 marks another major milestone in evaluating the potential benefit of HCB101 for these patient populations," said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. "Based on the preclinical head-to-head comparison studies, HCB101 repeatedly demonstrated superior efficacy and excellent safety profiles in comparison with several similar biologics currently being investigated in clinical trials targeting the same SIRPα-CD47 pathway. I am immensely proud of the teamwork that has brought our differentiated program to this point with only 2.6 years from the Company's inception to IND and now first-patient-in. HanchorBio is dedicated to discovering and developing immunotherapies to overcome the inadequacies of PD-1/L1 therapies with our proprietary FBDB™ technology platform."

"There is an urgent need for new treatment options for patients with cancer, particularly those who cannot tolerate currently available therapies," commented Jason Tsai, M.D., M.S., Chief Medical Officer of HanchorBio. "Through blockade of the SIRPα-CD47 pathway, HCB101 brings additional armament to fight cancer. Our goal is to bring transformative treatment options for patients with cancer by developing HCB101 as a foundational innate immunity checkpoint immunotherapy and open the door to innate-adaptive combination immuno-oncology therapy."

HCB101 is an engineered fusion protein using the Company's proprietary Fc-based designer biologics (FBDB™) technology platform that blocks the "do not eat" signal from the SIRPα-CD47 pathway, which inhibits the ability of macrophages to engulf and destroy cancer cells. Preclinical studies have shown that HCB101 has anti-tumor activity across a wide range of solid tumors and hematological malignancies. Unlike other similar agents, HCB101 exhibits excellent safety profiles in the repeat-dose cynomolgus monkey toxicology studies, as no abnormality of RBC or platelet levels were observed, with a potential as the best-in-class anti-SIRPα-CD47 immunotherapy.

HanchorBio owns worldwide commercial rights to HCB101.

About HCB101

Discovered through a structure-guided protein design and engineering supplemented with relevant screening technologies, HCB101 is an engineered extracellular domain of SIRPα fused to the Fc region of IgG₄. HCB101 triggers potent phagocytic activity of the macrophages by primarily blocking the "do not eat" signal between macrophages and tumor cells. Based on the extensive in-vitro and in-vivo preclinical data, HCB101 is potentially a safer and more potent biologic than the anti-CD47 monoclonal antibodies and SIRPa fusion proteins currently being investigated in clinical trials. Furthermore, quantitative RNA transcriptional analysis indicated that HCB101 triggered distinct gene expression profiles inside the tumor and in the tumor microenvironment compared to other relevant clinical candidates, suggesting that HCB101 might exhibit unique mechanisms of action. Using HCB101 as the foundation, our pipeline includes other arms targeting both adaptive and innate immunity to help revolutionize the treatment of patients with cancer and other debilitating diseases.

About Multi-Regional Clinical Trial of HCB101 (NCT05892718)

HCB101-101 is a multi-regional, multi-center, open-label, dose-finding, first-in-human (FIH) study of adults with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma in the United States and Taiwan. The purposes of the study are to evaluate the safety, tolerability, pharmacokinetics, and clinical anti-tumor activity of HCB101 via intravenous injections. HCB101-101 has already received IND clearance by the U.S. FDA in April 2023 and the Taiwan FDA in July 2023.

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