The trial aims to assess HX044’s efficacy in subjects with advanced solid tumours. Credit: Volha_R / Shutterstock.

Chinese biotechnology company Hanx Biopharmaceuticals has dosed the first subject in the Phase I trial of HX044, a bispecific antibody designed to treat advanced solid tumours, in Australia.

Independently developed by the company, HX044 is intended to combat a range of malignant tumours, including those resistant to programmed death 1 (PD-1) inhibitors.

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These include tumour types such as non-small cell lung cancer, melanoma, renal cell carcinoma, and gastrointestinal cancers.

Hanx described the drug as a ‘next-generation’ immune-checkpoint inhibitor that represents a ‘breakthrough’ in cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) immunotherapy.

HX044 is engineered to expand the therapeutic window, optimise safety and enhance anti-tumour immune responses.

The drug candidate has reportedly shown ‘promise’ in preclinical models, particularly against PD-1-resistant ‘cold’ tumours.

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Its cis-binding mechanism is claimed to improve Treg-depletion function in the tumour microenvironment.

The HX044-I-01 clinical trial aims to assess HX044’s safety, initial efficacy, tolerability and pharmacokinetics in subjects with advanced solid tumour malignancies.

Hanx Biopharmaceuticals chairman Dr Faming Zhang said: “We are thrilled to see the first patient entered into a 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.”

In May 2023, Hanx Biopharmaceuticals received approval from the US Food and Drug Administration (FDA) for a Phase I/II trial of its drug candidate HX-009 for relapsed/refractory lymphoma.

Based in Wuhan, the company aims to provide safe medical solutions to individuals worldwide, with a focus on ‘first-in-class and best-in-class’ therapies for cancer and autoimmune diseases.

Its immunotherapies are intended to provide patients worldwide with affordable, safe and effective medical solutions that address the challenges of major diseases.