#USA #Orlando #HanchorBio #HCB101 #Non-Hodgkin Lymphoma

HanchorBio's Innovative HCB101 Monotherapy Shows Promise for Non-Hodgkin Lymphoma

HanchorBio Inc., a clinical-stage biotechnology company, recently presented its latest findings from a Phase 1 monotherapy study of HCB101 at the 67th Annual Meeting of the American Society of Hematology (ASH), held from December 6-9, 2025, in Orlando, Florida. This groundbreaking research focuses on the treatment of relapsed/refractory non-Hodgkin lymphoma (R/R NHL), marking a significant step in the company's commitment to developing advanced immunotherapies.

Understanding HCB101

HCB101 is classified as a 3.5th-generation SIRPα-Fc fusion protein that operates through a unique mechanism, targeting CD47. This innovation is designed to enhance the safety profile of anti-CD47 therapies, minimizing risks such as anemia and thrombocytopenia that previous treatments have faced. HanchorBio’s proprietary platform, FBDB™, facilitated the development of HCB101, allowing it to selectively engage in immune activities crucial for fighting cancer.

Key Findings from the ASH Presentation

During the ASH meeting, HanchorBio highlighted notable outcomes from its ongoing multinational, open-label Phase 1 study (NCT05892718) assessing HCB101. The study included 13 patients diagnosed with relapsed or refractory non-Hodgkin lymphoma, who received doses ranging from 5.12 to 24.0 mg/kg. Here are some key findings:

• - Safety Profile: No dose-limiting toxicities were observed. All treatment-related adverse events were classified as Grade 1-2, indicating a favorable safety profile that spares patients from severe cytopenia.
• - Receptor Occupancy: The study demonstrated effective CD47 receptor occupancy levels of 75-85% at 1.2 mg/kg and over 90% at 8 mg/kg, evidencing a broad pharmacologic window.
• - Efficacy Signals: One patient with marginal zone B-cell lymphoma experienced a confirmed partial response, showing a 43.3% reduction in tumor size by Week 8, which improved to 89.5% by Week 16, indicating the treatment's potential efficacy.

Insight from Leadership

Alvin Luk, PhD, MBA, who serves as the President and Chief Executive Officer of HanchorBio (U.S.), presented the data. As a leader recently appointed to spearhead the global development of the company’s late-stage products, Luk remarked on the significance of the findings, stating, “The inclusion of HCB101 monotherapy data reflects the strong translational foundation and clinical potential of our SIRPα-CD47 backbone.”

Scott Liu, PhD, founder and chairman of HanchorBio, emphasized the promising safety and early clinical activity, particularly in a heavily pretreated patient cohort. He expressed optimism about expanding the application of HCB101 in hematologic malignancies and exploring macrophage/T-cell combination strategies.

Clinical Implications

The implications of these findings are substantial. HCB101 represents a shift towards safer immunotherapy options for patients with limited treatment choices, particularly in aggressive malignancies like non-Hodgkin lymphoma. The early signs of clinical activity combined with a robust safety profile indicate that HCB101 may soon occupy a vital role in oncological treatment regimens. HanchorBio's advancements could redefine treatment strategies and offer hope to patients battling resistant forms of lymphoma.

As HanchorBio prepares to engage further with the global hematology community and explore additional opportunities for HCB101, the data presented at ASH 2025 signifies a potential breakthrough in immunotherapy for non-Hodgkin lymphoma patients. The ongoing commitment to addressing unmet medical needs through innovative therapies positions HanchorBio as a company to watch closely in the future.