Hanx Biopharmaceuticals, a biotechnology company focused on next-generation immunotherapies, has announced the first patient dosed in a Phase 1 clinical trial of HX044. The trial, which began in Australia on December 30, 2024, is evaluating HX044 in patients with advanced solid tumors. This first-in-human study (HX044-I-01, NCT06649708) aims to assess the safety, tolerability, pharmacokinetics, and initial efficacy of the novel bispecific antibody.
HX044 is a first-in-class bispecific antibody developed by Hanx Biopharmaceuticals. It is designed as a next-generation immune-checkpoint inhibitor targeting a wide range of malignant tumors, including those resistant to PD-1 inhibitors. These tumors include non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and gastrointestinal cancers. HX044 represents a new generation of CTLA-4 immunotherapy, engineered to expand the therapeutic window, optimize safety, and enhance anti-tumor immune responses.
Targeting the Tumor Microenvironment
According to Dr. Henry Li, CEO/CSO of Hanx Biopharmaceuticals, HX044 enhances Treg-depletion function within the tumor microenvironment through its effective cis-binding mechanism. Preclinical models have demonstrated strong efficacy against PD-1-resistant "cold" tumors, suggesting superior therapeutic potential.
Clinical Trial Details
The Phase 1/IIa study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HX044 in patients with advanced solid tumor malignancies. The trial is currently underway in Australia, with plans for further expansion.
Addressing Unmet Needs in Cancer Therapy
"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," said Dr. Faming Zhang, Chairman of Hanx Biopharmaceuticals. "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."
Hanx Biopharmaceuticals is dedicated to developing affordable, safe, and effective medical solutions for patients worldwide, focusing on first-in-class and best-in-class therapies for cancer and autoimmune diseases.
