HanchorBio Inc. presented promising interim data for its checkpoint inhibitor HCB101 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating the treatment's potential to balance safety and efficacy in cancer immunotherapy. The Phase 1b dose-escalation trial (NCT05892718) showed favorable safety and tolerability across escalating doses, with early clinical signs of anti-tumor activity including confirmed partial responses in patients with head and neck cancer (HNSCC) and non-Hodgkin's lymphoma.
Breakthrough Mechanism Targets CD47 Pathway
HCB101 utilizes an engineered signal-regulatory protein α (SIRPα) that targets CD47, colloquially known as the "don't eat me" protein, which allows cancer cells to evade immune detection. This checkpoint inhibitor approach activates the body's own defenses to kill cancer cells by blocking proteins that enable tumor immune evasion. The treatment has demonstrated efficacy against both solid and hematologic tumors while maintaining a strong safety profile.
The interim Phase 1b data revealed high-level CD47 receptor occupancy in peripheral immune cells, indicating successful target engagement. Earlier Phase 1a trial data confirmed 100% safety across all dose levels, with HCB101 achieving a 26.7% disease control rate and 16.7% of subjects maintaining disease control for over four months.
Addressing Traditional Treatment Limitations
"HCB101 solves the challenge that traditional CPI-based treatments face — the trade-off between safety and efficacy," commented Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. Previous generations of checkpoint inhibitor treatments typically excelled in either safety or effectiveness, but rarely both simultaneously.
The treatment can function as both a standalone therapy and in combination with other treatments, offering flexibility in clinical applications. Compared to chemotherapy, checkpoint inhibitors like HCB101 have demonstrated greater long-term remission rates and broader efficacy across various cancer types.
Multi-Region Phase 2 Trial Underway
Following the successful Phase 1b results, HanchorBio launched a Phase 2 trial in March 2025 spanning Taiwan, the United States, and China. The study has enrolled participants from diverse populations across multiple cancer types, including lung, head and neck, stomach, and breast cancers. The US portion of the trial received FDA approval and will be conducted through US healthcare institutions.
Rapid Development Timeline
HanchorBio achieved investigational new drug (IND) status for HCB101 in just 2.3 years from company inception, establishing a record for a biotech company of its size. This accelerated development timeline helped attract USD 80 million in funding and demonstrates the company's streamlined approach combining over 30 years of industry expertise with state-of-the-art R&D facilities.
The company's proprietary Fc-Based Designer Biologics (FBDB™) platform has successfully advanced multiple pipeline programs from discovery through clinical trials, supporting HanchorBio's end-to-end development approach in immuno-oncology therapeutics.
