Hanx Biopharmaceuticals, CO. Ltd, an innovative biotechnology company developing next-generation immunotherapies to address the challenges of unmet medical need diseases, 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).

HX044 is an innovative bispecific antibody independently developed by Hanx Biopharmaceuticals. It is a first-in-class and considered to be a next generation immune-checkpoint inhibitor designed to treat a wide range of malignant tumors, including PD-1-resistant solid tumors such as non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and gastrointestinal cancers. HX044 represents a new generation CTLA-4 immunotherapy by expanding the therapeutic window, optimizing safety, and enhancing antitumor immune responses, showcasing a breakthrough in CTLA-4 immunotherapy.

"We are thrilled to see the first patient entered into clinical study, which marks a significant development milestone for this therapeutic candidate in our pipeline. This achievement demonstrated our strong R&D and clinical development capacity, and it reflects our commitment to addressing unmet medical needs for the patients. We will be working diligently to move this project forward", said Dr. Faming Zhang, Chairman of Hanx Biopharmaceuticals. "HX044 is a next generation CTLA-4 bispecific antibody fully developed in-house by the company, starting from molecule design. It enhances T_reg-depletion function within tumor microenvironment through its effective cis-binding mechanism. It shows strong efficacy even against PD-1-resistant "cold" tumors in preclinical models, demonstrating superior therapeutic potential", commended by Dr. Henry Li, CEO/CSO of Hanx Biopharmaceuticals.