On September 5, 2024 HanX Biopharmaceuticals reported that the first Phase 2 clinical trial of HX009 in combination therapy received approval from the National Medical Products Administration (NMPA) (Press release, HanX Biopharmaceuticals, SEP 5, 2024, View Source [SID1234655961]). This application, which met the relevant drug registration requirements, approved the Phase 2 clinical trial of HX009 in combination therapy for biliary tract cancer (BTC).
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HX009 is a clinical-stage investigational anti-PD-1 and anti-CD47 bifunctional large molecule cancer immunotherapy independently developed by Hans-Itai. Two Phase I single-agent dose-escalation trials in solid tumors have been successfully completed in Australia and China. Phase I monotherapy data demonstrated a favorable safety and tolerability profile, with single-agent anti-tumor efficacy observed in multiple indications, including biliary tract malignancies. Existing data support advancement into Phase II and combination trials. The company currently plans to conduct multicenter Phase II trials in multiple clinical indications.
Dr. Lei Zhang, Chief Medical Officer of Hans Ait, said: "We are very pleased that HX009 has received its first clinical approval for combination use from the National Medical Products Administration. Although the application of immunotherapy (including PD-1/PD-L/CTLA4 antibodies, etc.) has improved the survival prognosis of BTC patients to a certain extent, some patients still lack response to immunotherapy and suffer from immunotherapy resistance. In the Phase I clinical trial, we have observed that HX009 monotherapy can induce objective remission of biliary tract malignancies, suggesting the therapeutic potential of HX009 in this indication. We look forward to rapidly advancing this clinical trial and providing new treatment options for patients as soon as possible."