HanchorBio’s novel immunotherapy drug candidate HCB101 has reached a significant milestone in its Phase I clinical trial. Three patients with advanced solid tumors received a high intravenous dose of 18 mg/kg, and no dose-limiting toxicities or serious adverse events were observed during the monitoring period, demonstrating favorable tolerability. This result was unanimously approved by the Clinical Safety Review Committee at 8:00 PM Taiwan time on July 14, laying a critical foundation for further dose escalation and broader clinical application.

HCB101 is a novel monofunctional fusion protein biologic targeting the CD47–SIRPα pathway, a highly promising target in the field of cancer immunotherapy. This pathway plays a crucial role in enabling tumor cells to evade immune attacks. By blocking the “don’t eat me” signal of CD47, HCB101 restores macrophage-mediated phagocytosis of tumor cells, enhances innate immune responses, and activates T cells to exert antitumor effects.

In earlier dose escalation phases, HCB101 had already demonstrated clinical activity at a 5.12 mg/kg dose. One patient with advanced head and neck cancer showed significant and sustained tumor shrinkage, indicating preliminary antitumor efficacy. The successful escalation to 18 mg/kg without signs of toxicity not only confirms the drug’s safety profile but also highlights its wide therapeutic window—the dosage range between the minimum effective dose and the maximum tolerated dose. A broad therapeutic window adds significant value for dose design, risk management, and future clinical expansion. It also facilitates personalized dose adjustments and combination therapy strategies.

HanchorBio emphasized that HCB101 was designed with a differentiated approach from the outset. Both preclinical and Phase I clinical data have shown that the drug possesses high tumor-type adaptability, a low target saturation dose, and a low red blood cell binding rate. According to internal research, HCB101 has demonstrated significant efficacy in over 80 xenograft tumor models, suggesting broad applicability across multiple cancer types. In terms of dosing, HCB101 achieves target saturation at relatively low concentrations, meaning therapeutic effects can be realized with reduced toxicity. Additionally, its red blood cell binding rate is significantly lower than that of other marketed CD47 inhibitors, minimizing the risks of hemolysis and anemia and supporting better clinical tolerability.

Compared with other CD47–SIRPα-targeted therapies in more advanced development stages, HCB101 stands out with its competitive safety profile and strong potential in both monotherapy and combination therapy. It has emerged as one of the most promising next-generation candidates in the CD47–SIRPα therapeutic space.

HanchorBio has already planned further dose escalation and will initiate multiple combination therapy clinical trials targeting a range of difficult-to-treat solid tumors, including head and neck cancer, lung cancer, gastric cancer, breast cancer, and colorectal cancer. The company also intends to advance HCB101 into mid-stage and pivotal clinical trials and is actively evaluating eligibility for the U.S. FDA’s expedited review programs to accelerate development and commercialization.

HanchorBio affirmed its commitment to deepening its clinical and strategic initiatives, strengthening partnerships with global clinical centers and research institutions. The company aims to develop HCB101 into a globally competitive immunotherapy drug. If ongoing trial results continue to show promise, HCB101 could become a novel treatment option that balances efficacy and safety for patients with advanced solid tumors worldwide—ushering in a new chapter in immuno-oncology.

Resource: 漢康生技HCB101 臨床突破高劑量