On September 11, 2024 HanX Biopharmaceuticals reported that HX044 had received clinical trial approval from the Bellberry Human Research Ethics Committee (HREC) in Australia (Press release, HanX Biopharmaceuticals, SEP 11, 2024, View Source [SID1234655962]). HanX’ application, which complies with the requirements of the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2023), approved the conduct of a Phase I clinical trial: 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.
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HX044 is a first-in-class investigational bispecific antibody for cancer immunotherapy developed independently by Hans-Iitra. Preclinical studies have demonstrated enhanced potency and a wider therapeutic window compared to previous-generation immunotherapy inhibitors , while also demonstrating promising results in tumor models refractory to immunotherapy inhibitors ("cold tumors"). Hans-Iitra has completed all necessary preclinical development, including GMP manufacturing and GLP toxicology studies, and plans to initiate Phase I single-agent dose escalation trials in humans across various solid tumors in Australia and China.
Dr. Qixiang Li, CEO/Chief Scientific Officer of HansItai, said: "The approval of HX044 for clinical trials is a new important milestone for HansItai. H044 is a new type of cancer immunotherapy bispecific antibody that we independently developed from molecular design. Through the close cooperation and efforts of all departments of HansItai, HX044 was approved for clinical trials very smoothly, further strengthening the company’s clinical layout in the cancer immunotherapy pipeline, and fully demonstrating the company’s innovation and R&D strength in cancer immunotherapy. We will quickly advance this clinical trial and look forward to seeing the potential for efficacy as soon as possible and helping patients as soon as possible."