Early Phase 1 monotherapy data demonstrate cytopenia-sparing safety, broad pharmacologic window, and early clinical activity in relapsed/refractory non-Hodgkin lymphoma (NHL)

TAIPEI, SHANGHAI, and SAN FRANCISCO, Dec. 8, 2025 /PRNewswire/ -- HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today presented new first-in-human data from its ongoing Phase 1 monotherapy study of HCB101, a 3.5^th-generation SIRPα-Fc fusion protein, in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) at the 67^th Annual Meeting of the American Society of Hematology (ASH), held December 6-9, 2025, in Orlando, Florida.

The ASH Annual Meeting is the world's premier platform for clinical and translational advances in hematology. This year, over 8,200 abstracts were accepted globally, reaffirming ASH's position as one of the most competitive and influential medical congresses in hematology and oncology, with historical rejection rates of approximately 28%.

The accepted abstract (#3299) features a focused sub-analysis from HanchorBio's ongoing multinational, open-label Phase 1 study (NCT05892718) evaluating HCB101 monotherapy across solid and hematologic malignancies, highlighting results from the R/R NHL cohort.

Key Results (data cutoff: October 14, 2025):

• Thirteen patients with R/R NHL received HCB101 (5.12 – 24.0 mg/kg QW). No dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached.
• All treatment-related adverse events were Grade 1-2, confirming a cytopenia-sparing safety profile.
• CD47 receptor occupancy (RO) reached ≥ 75-85% at 1.2 mg/kg and ≥ 90% at 8 mg/kg, demonstrating a broad pharmacologic window.
• A confirmed partial response (PR) was observed in a patient with marginal zone B-cell lymphoma at 8.00 mg/kg, with -43.3% tumor reduction at Week 8 deepening to -89.5% by Week 16 at the same dose.

The results were presented by Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer and Chief Executive Officer (U.S.) of HanchorBio during the ASH 2025 poster session. Dr. Luk recently joined HanchorBio to lead the company's global development of late-stage products and U.S. operations, advancing its next-generation immuno-oncology pipeline.

"Despite ASH's highly competitive selection process, the inclusion of HCB101 monotherapy data reflects the strong translational foundation and clinical potential of our SIRPα-CD47 backbone," said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. "We're encouraged by the favorable safety and early signs of clinical activity seen in the heavily pretreated patient population. These findings validate the translational strength of our FBDB™ platform, and we look forward to engaging with the global hematology community as we expand HCB101 into hematologic malignancies and macrophage/T-cell combination strategies."

"Presenting these data at ASH marks an important step for HanchorBio and our team," added Dr. Alvin Luk. "Moving from molecular design to early clinical validation highlights the potential of selective SIRPα-CD47 blockade to achieve both safety and effective immune activation in patients with limited treatment options."

About HCB101: A Differentiated CD47-SIRPα Blockade
HCB101 is a 3.5^th-generation, affinity-optimized SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio's proprietary FBDB™ platform. It is engineered for selective CD47 targeting with low red blood cell (RBC) binding, thereby avoiding the anemia and thrombocytopenia commonly associated with earlier anti-CD47 monoclonal antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging. Key differentiators of HCB101:

• Enhanced safety: Cytopenia-sparing profile, with no DLTs observed up to 30 mg/kg and receptor occupancy >90% at ≥1.28 mg/kg, supporting a broad therapeutic window.
• Robust immune activation: Engineered to enhance ADCP and bridge innate-to-adaptive immunity, with evidence of durable immune-mediated tumor control in monotherapy.
• Broad tumor applicability: Demonstrated activity across >80 PDX and CDX preclinical models, with early clinical signals in gastric cancer, TNBC, HNSCC, non-Hodgkin lymphoma, and ovarian cancer.
• Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in 2L gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in 1L TNBC and 2L HNSCC, substantially exceeding historical benchmarks.

About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TPEx: 7827) is a global biotechnology company specializing in immuno-oncology. It is led by an experienced team of pharmaceutical industry veterans with a proven track record in biologics discovery and international development, aiming to rewrite the landscape of cancer therapies. Committed to reactivating the immune system to fight diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By advancing breakthroughs in multi-functional, innovative molecular configurations in R&D and improving CMC manufacturing processes, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: https://www.HanchorBio.com

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SOURCE HanchorBio Inc.