HCB301 / HanchorBio - LARVOL DELTA

Coordinated SIRPα-PD-L1-TGFβ modulation with HCB301: Early safety and disease control in a first-in-human phase 1 study (KSMO 2026) - No abstract available

Clinical • First-in-human • P1 data • PD-L1 • SIRPA • TGFB1

HCB301-101: Early Safety and Disease Control From a Phase 1 Study of a Tri-Functional SIRPα/PD-L1/TGF-β Biologic in Advanced Solid Tumors (ESMO 2026) - No abstract available

Clinical • Metastases • P1 data • Oncology • Solid Tumor • PD-L1 • SIRPA • TGFB1

First-in-human phase 1 evaluation of the world's first tri-specific SIRPα–PD-1–TGF-β Fc fusion protein HCB301 in advanced solid tumors. (ASCO 2026) - P1 | "These first-in-human data establish the clinical feasibility of tri-specific Fc fusion immunotherapy, validating simultaneous targeting of innate, adaptive, and stromal immune resistance mechanisms within a single molecule. The favorable early safety profile, predictable pharmacokinetics, and initial biological and antitumor signals support continued dose escalation and cohort expansion of HCB301."

First-in-human • IO biomarker • Metastases • P1 data • Trispecific • Cardiovascular • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Hypertension • Lymphoma • Oncology • Solid Tumor • PD-1 • PD-L1 • SIRPA • TGFB1

HanchorBio Doses First Patient in Taiwan in Phase 1 Trial of HCB301 (HanchorBio Press Release) - "HCB301-101 is an open-label, multiregional, multicenter, dose-escalation study evaluating HCB301 in adults with advanced solid tumors or relapsed/refractory classical Hodgkin lymphoma. The study is designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity, while supporting dose finding for future development."

Trial status • Hodgkin Lymphoma • Solid Tumor

First-in-human phase I evaluation of HCB301, a tri-specific SIRPα-PD-1-TGFβ fusion protein: Safety, pharmacokinetics, and multisystem immune activation (ESMO-TAT 2026) - P1 | "HCB301, the first tri-specific SIRPα-PD-1-TGFβ fusion protein demonstrated manageable safety, linear PK, and PD evidence of coordinated innate and adaptive immune activation. These findings support continued dose escalation and further evaluation in immune-resistant solid tumors."

Clinical • First-in-human • IO biomarker • P1 data • PK/PD data • Trispecific • Oncology • Solid Tumor • CD8 • PD-1 • SIRPA • TGFB1

An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: FBD Biologics Limited | Trial completion date: Aug 2026 ➔ May 2027 | Trial primary completion date: Aug 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor

HanchorBio Presents Preclinical Data on HCB301 at SITC 2025 (PRNewswire) - "Strong immune activation: HCB301 induced robust antibody-dependent cellular phagocytosis (ADCP), activated tumor-associated macrophages, and increased CD8+ T cell infiltration. Synergistic antitumor efficacy: In CT26, MC38, and B16F10 models, HCB301 demonstrated superior tumor growth inhibition compared with single- or dual-arm comparators."

Preclinical • Oncology

HCB301: A Novel Tri-Specific Fc Fusion Protein Targeting PD-L1, CD47, and TGFβ Remodels the Tumor Microenvironment and Enhance Anti-Tumor Immunity (SITC 2025) - "In vivo efficacy was evaluated using NPG™ mice bearing FaDu (HNSCC)/human PBMC co-mixed xenografts, as well as hPD1/hPDL1/hCD47/hSIRPα transgenic BALB/c mice bearing 4T1-hPDL1/hCD47 tumors.Results HCB301 effectively blocked PD-L1 signaling at a level comparable to atezolizumab and suppressed TGF-β1 activity more potently than M7824, a clinically studied bifunctional fusion protein targeting PD-L1 and TGFβ.4 Importantly, HCB301 induced robust phagocytosis of PD-L1-high, CD47-positive cancer cells by human MDMs while showing no off-target phagocytosis of red blood cells. This contrasts with magrolimab analogs and suggests a favorable hematologic safety profile, mitigating concerns observed with some CD47-targeting agents.5 In vivo, HCB301 elicited robust anti-tumor activity, equivalent to a triple-agent combination targeting PD-L1, CD47, and TGF-β individually, in both FaDu and 4T1 tumor models.Conclusions HCB301 represents a novel therapeutic approach that simultaneously..."

Biomarker • IO biomarker • Trispecific • Tumor microenvironment • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • SIRPA • TGFB1

HanchorBio Showcases Pipeline Momentum with…HCB301 Data Across…Major Oncology Meetings in Q4 2025 (PRNewswire) - "HanchorBio...announced that...preclinical results from HCB301, its next-generation tri-specific checkpoint immunotherapy, will be presented at...major international oncology congresses in the fourth quarter of 2025. The upcoming presentations will showcase...preclinical data from HCB301, underscoring the company's innovation in advancing next-generation innate immune checkpoint therapies."

Preclinical • Solid Tumor

HanchorBio Announces Acceptance of HCB301 Abstract for Poster Presentation at SITC 2025 Annual Meeting (PRNewswire) - "The accepted abstract...will be presented on Saturday, November 8, 2025. The presentation will highlight preclinical efficacy and safety data supporting HCB301's potential as a first-in-class immune-enhancing biologic that targets key mechanisms of tumor immune evasion."

Preclinical • Oncology

An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: FBD Biologics Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor

An Engineered Sirpα Fused to Anti-Pd-L1 and Tgf-β Fusion Protein (HCB301) in Subjects with Selected Advanced Tumors (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: FBD Biologics Limited | Initiation date: Sep 2024 ➔ Jan 2025

Metastases • Trial initiation date • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor • TGFB1

An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: FBD Biologics Limited

Metastases • New P1 trial • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor • TGFB1