HCB101

FACO 2025 presentation highlights HCB101's favorable safety, strong receptor occupancy, and confirmed responses in patients with advanced cancers. TAIPEI, SHANGHAI, and SAN FRANCISCO, Oct. 23, 2025 /PRNewswire/ -- HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies, today presented new results from its ongoing Phase 1 study of HCB101, a novel SIRPα-engineered Fc fusion protein, at the 13th International Conference of the Federation of Asian Clinical Oncology (FACO 2025), held October 24-25, 2025, in Shanghai, Mainland China. Continue Reading HanchorBio Presents Phase 1 HCB101 Clinical Results at FACO 2025 Demonstrating Safety and Early Antitumor Activity Dr. Fangling Ning, an investigator at the Affiliated Hospital of Binzhou Medical University, stated, "HCB101 is showing early promise as a differentiated therapy targeting the CD47-SIRPα axis, with encouraging signals of efficacy in both solid tumors and lymphomas. Importantly, the novel design (engineered with the help of AI) effectively mitigated anemia and cytopenias, which have been challenges with prior agents in this class. These findings provide a strong foundation for further clinical development." The 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", reported updated results from the multinational, first-in-human trial (NCT05892718). Key highlights from the study as of July 10, 2025, include: Favorable safety profile: Among 49 patients enrolled across 10 dose levels (0.08-18.00 mg/kg, QW), only one dose-limiting toxicity (DLT) was observed, a transient Grade 3 thrombocytopenia at the 2.56 mg/kg dose level. Consistent receptor occupancy (RO): >90% CD47 RO achieved at doses ≥1.28 mg/kg. Encouraging antitumor activity: Two confirmed partial responses (PRs) in head and neck squamous cell carcinoma (HNSCC) and non-Hodgkin lymphoma, alongside durable disease control in multiple patients. "The presentation of HCB101 data at FACO 2025 underscores both the scientific innovation of our FBDB™ platform and our commitment to developing next-generation immunotherapies with global impact," said Scott Liu, Ph.D., Chairman, CEO, and Founder of HanchorBio. "We are encouraged by the excellent safety profile and initial responses observed in heavily pretreated patients. These monotherapy data establish safety, PK/PD, and early activity, providing the foundation for our ongoing combination trials testing HCB101 layered onto standard backbones in multiple tumor types. This marks an important step toward realizing our vision of bringing transformative, differentiated treatments to patients facing cancers with high unmet need." About HCB101: A Differentiated CD47-SIRPα Blockade HCB101 is a 3.5th-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 24 mg/kg and >90% RO 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, triple-negative breast cancer, head and neck squamous cell carcinoma, non-Hodgkin lymphoma, and ovarian cancer. Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in second-line gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in first-line TNBC and second-line HNSCC, substantially exceeding historical benchmarks. About HCB101 Monotherapy Clinical Trial (HCB101-101; NCT05892718) HCB101-101 is an ongoing multi-national, multi-center, open-label, dose-finding Phase 1 study evaluating HCB101 in adults with advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma. Conducted across sites in Taiwan, the United States, and Mainland China, the study uses a stepwise accelerated flat-dosing adjustment strategy to optimize safety and dosing. The primary objectives are to assess safety and tolerability, while secondary endpoints include pharmacokinetics, pharmacodynamics, and antitumor activity. Early data demonstrate a favorable safety profile, dose-proportional pharmacokinetics, high-level CD47 receptor occupancy, and confirmed partial responses in heavily pretreated solid tumor and lymphoma patients. These findings support the continued development of HCB101 in expansion cohorts and future combination studies. 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 global development, aiming to rewrite 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 making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: SOURCE HanchorBio Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Presentations highlight HCB101's differentiated profile and introduce first preclinical data from HCB301, underscoring HanchorBio's innovation in next-generation immunotherapies TAIPEI, SHANGHAI and SAN FRANCISCO, Oct. 20, 2025 /PRNewswire/ -- HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies, today announced that new clinical data from HCB101, its differentiated, engineered SIRPα-Fc fusion protein, and the preclinical results from HCB301, its next-generation tri-specific checkpoint immunotherapy, will be presented at five major international oncology congresses in the fourth quarter of 2025. The upcoming presentations will showcase progress from HCB101, including both the HCB101-101 monotherapy (NCT05892718) and the HCB101-201 combination (NCT06771622) studies, as well as the preclinical data from HCB301, underscoring the company's innovation in advancing next-generation innate immune checkpoint therapies. Federation of Asian Clinical Oncology (FACO), October 24-25, 2025 – Two poster presentations on HCB101 monotherapy and HCB101 in combination with standard of care in advanced cancers Society for Immunotherapy of Cancer (SITC), November 5-9, 2025 – Two late-breaking poster presentations from HCB101-101 and HCB101-201, highlighting safety, pharmacology, and emerging efficacy signals – One poster presentation from HCB301, revealing the first-time the preclinical data from HanchorBio's novel tri-specific fusion protein targeting CD47-SIRPα, PD-1, and TGFb pathways ESMO Asia Congress, December 5-7, 2025 – One abstract updating the results from HCB101-101, demonstrating safety and activity across solid tumors and hematologic malignancies American Society of Hematology (ASH) Annual Meeting, December 6-9, 2025 – Poster presentation of the first-in-human Phase 1 study of HCB101 in relapsed/refractory non-Hodgkin lymphoma ESMO Immuno-Oncology Congress (ESMO-IO), December 10-12, 2025 – One abstract integrating the HCB101 monotherapy and combination data across multiple solid tumor indications "Presenting across five major oncology meetings in one quarter underscores both the breadth and pace of HCB101's clinical progress," said Scott Liu, Ph.D., Chairman, CEO, and Founder of HanchorBio. "HCB101 continues to validate our differentiated approach to CD47-SIRPα blockade, while the first preclinical data from HCB301 showcase the innovation of our FBDB™ platform in advancing next-generation, multi-checkpoint therapies. Together, they highlight HanchorBio's commitment to delivering transformative treatments for patients with difficult-to-treat cancers and advancing the next generation of immunotherapies." About HCB101: A Differentiated CD47-SIRPα Blockade HCB101 is a 3.5th-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: Demonstrates a cytopenia-sparing profile, with no dose-limiting toxicities observed up to 24 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, triple-negative breast cancer, head and neck squamous cell carcinoma, non-Hodgkin lymphoma, and ovarian cancer. Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in second-line gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in first-line TNBC and second-line HNSCC, substantially exceeding historical benchmarks. About HCB301: a Tri-Specific Checkpoint Immunotherapy HCB301 is HanchorBio's next-generation immunotherapy designed to integrate three synergistic mechanisms into a single molecule: CD47-SIRPα blockade to activate macrophage-mediated phagocytosis, PD-1 inhibition to restore exhausted T cells, and TGF-b pathway suppression to improve tumor micro-environment. Developed using the proprietary FBDB™ platform, HCB301 represents a next-generation approach to multi-checkpoint immunotherapy. Preclinical studies demonstrated enhanced immune activation and potent antitumor activities, and the first results will be presented at SITC 2025. About HanchorBio Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx), a global biotechnology company specializing in immuno-oncology, is led by an experienced team of pharmaceutical industry veterans with a proven track record of success in biologics discovery and global development, aiming to rewrite 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 making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: SOURCE HanchorBio Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED