Hanx Biopharma Starts Patient dosing Phase 1 Trial of HX044

Hanx Biopharma, Inc. Ltd, a pioneering biotechnology firm focused on creating next-generation immunotherapies to tackle the challenges posed by unmet medical needs, announced the first patient dosing in Australia on December 30, 2024, for the 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 tumour malignancies, NCT06649708).

HX044 is a groundbreaking bispecific antibody developed independently by Hanx Biopharmaceuticals. It is an innovative first-in-class drug regarded as a next-generation immune-checkpoint inhibitor intended for the treatment of various malignant tumors, including PD-1-resistant solid tumors like non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and gastrointestinal cancers. 

“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 Treg-depletion function within tumour microenvironment through its effective cis-binding mechanism. It shows strong efficacy even against PD-1-resistant “cold” tumours in preclinical models, demonstrating superior therapeutic potential”, commended by Dr. Henry Li, CEO/CSO of Hanx Biopharmaceuticals.