#China #Shanghai #cancer therapy #HanchorBio #HCB101

HanchorBio's HCB101 Phase 1 Results at FACO 2025

During the prestigious 13th International Conference of the Federation of Asian Clinical Oncology (FACO 2025) held in Shanghai, HanchorBio Inc. shared compelling data from their ongoing Phase 1 clinical study of HCB101, a novel therapeutic agent designed to target the CD47-SIRPα axis in advanced cancer cases. The presentation highlighted the safety, tolerability, and early antitumor activity of HCB101, which was engineered using HanchorBio's innovative FBDB™ platform.

Clinical Findings

Dr. Fangling Ning, who serves as an investigator at the Affiliated Hospital of Binzhou Medical University, emphasized that HCB101 is demonstrating significant potential as a unique therapy for both solid tumors and lymphomas. The study has yielded promising signals of efficacy, especially considering that HCB101’s design aims to minimize anemia and cytopenias—common side effects associated with earlier therapies in this classification.

The presentation's poster, titled _"Phase 1 Study of HCB101, a Novel Fc-engineered CD47-SIRPα Fusion Protein, Demonstrates Favorable Safety and Confirmed Responses in Solid and Hematologic Malignancies,"_ offered insightful updates on the multinational, first-in-human trial (NCT05892718). Here are some key highlights conveyed as of July 10, 2025:

• - Favorable Safety Profile: Among the 49 patients enrolled across ten dose levels, the study recorded only one dose-limiting toxicity—a temporary Grade 3 thrombocytopenia at a 2.56 mg/kg dosage.
• - Consistent Receptor Occupancy: The study reported over 90% occupancy of the CD47 receptor was achieved at doses greater than or equal to 1.28 mg/kg, indicating effective targeting capabilities.
• - Encouraging Antitumor Activity: Two confirmed partial responses were observed in patients with head and neck squamous cell carcinoma and non-Hodgkin lymphoma, alongside durable disease control in several others.

HanchorBio's Commitments

Scott Liu, Ph.D., Chairman, CEO, and Founder of HanchorBio, remarked on the significance of the presented data, noting that it reflects not only the company's innovative scientific methodologies but also their dedication to developing cutting-edge immunotherapies that can make a global impact. He was particularly encouraged by the favorable safety profile and early responses in patients who had undergone significant prior treatments.

Liu reiterated that these data lay the groundwork for pursuing combination trials of HCB101 with standard therapies across various tumor types. "This represents an important advancement in our mission to introduce transformative treatments for patients grappling with high unmet medical needs," he stated.

About HCB101

HCB101 is categorized as a 3.5th-generation, affinity-optimized SIRPα-Fc fusion protein, utilizing an intact IgG4 Fc backbone. What sets HCB101 apart is its engineered approach, which ensures selective targeting of CD47 with minimized binding to red blood cells. This innovative strategy allows for avoiding the anemia and thrombocytopenia pitfalls that previous anti-CD47 monoclonal antibodies encountered, all while promoting robust antibody-dependent cellular phagocytosis (ADCP).

Key Differentiation Points

• - Enhanced Safety: No dose-limiting toxicities experienced up to 24 mg/kg, combined with over 90% receptor occupancy at doses greater than 1.28 mg/kg, suggest a broad therapeutic window.
• - Immune Activation: Designed to enhance cellular phagocytosis alongside bridging innate to adaptive immunity, with indications of sustained tumor control in monotherapy.
• - Broad Applicability: Demonstrated effectiveness across over 80 preclinical models, with preliminary clinical indicators in solid tumors such as gastric and triple-negative breast cancers.

Clinical Trial Details

The HCB101-101 trial is an expansive, multi-national Phase 1 study aiming to evaluate HCB101 in adults suffering from advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma. Conducted across multiple sites in Taiwan, the US, and Mainland China, the study employs a methodical, accelerated dosing strategy to ensure optimal safety. Primary goals center on evaluating safety and tolerability, while secondary objectives assess pharmacokinetics, pharmacodynamics, and tumor response.

Conclusion

Early data reveal a favorable safety profile, dose-proportional pharmacokinetics, and notable receptor occupancy and antitumor activity. These promising results bolster the case for pursuing further development of HCB101 in expanding patient cohorts and potential combination studies, heralding a new chapter in the effort to combat cancer effectively. For more insights into HanchorBio and its pioneering work in immunotherapy, visit HanchorBio.com.