HX044 / HanX Biopharma - LARVOL DELTA

Non-clinical modeling the therapeutic window of HX044, a novel CTLA4xCD47 BsAb (AACR 2026) - "MOAs of the CTLA4-mAb (e.g. Ipilimumab or Ipi) for anti-cancer efficacy include: 1) ADCC/the associated TIL-Treg-depletion, 2) CTLA4-ligand (CD80/CD86) blockade/the associated T-cell activation in tdLN (tumor draning lymphonoda) (priming), and 3) Fc-mediated effector activities/the associated TME remodeling enhancing immunogenicity. The data could not necessarily confirm significant better safety over Ipi in the 40mg/kg dose level, thus higher tolerable dose for irAE in the presence of sufficient double-positive Treg cells in peripheral. Nevertheless, HX044 has significantly broadened therapeutic window over Ipi, via lower efficacious dose levels attributed to significantly enhanced ADCC activities."

Clinical • IO biomarker • Oncology • CD47 • CD80 • CD86 • SIRPA

Hanx Biopharmaceuticals, Ltd. Showcases Five Innovative Cancer Therapies at 2025 AACR Annual Meeting (PRNewswire) - "Hanx Biopharmaceuticals Ltd...highlighted its expanding oncology and autoimmune disease pipeline with five research poster presentations at the 2025 American Association for Cancer Research (AACR) Annual Meeting in Chicago (April 25–30). The presentations spotlighted novel bispecific antibodies and a CSF-1R inhibitor, underscoring the company's leadership in innovative cancer treatment strategies."

Clinical data • Solid Tumor

Hanx Biopharmaceuticals, Ltd. Announces First Patient Dosing in First-in-Human Phase 1 Clinical Trial of HX044 (PRNewswire) - "Hanx Biopharmaceuticals, CO. Ltd...announced the first patient dosing in Australia on Dec 30, 2024 for Phase 1 clinical trial of HX044 in patients with advanced solid tumors (HX044-I-01, A Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies, NCT06649708)."

Trial status • Oncology • Solid Tumor

HX044,FIH Study in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Hanx Biopharmaceuticals Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor