On December 7, 2024 HanX Biopharmaceuticals reported presented poster presentations at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting , held in San Diego, CA, USA, December 7–10 : " A Phase IB Clinical Trial INVESTIGATING the Safety, Tolerability, and Pharmacokinetics of HX009," and " A Novel BsAb Dual Targeting PD-1xCD47 in Patients with EBV+ Non-Hodgkin Lymphoma (NHL) (Press release, HanX Biopharmaceuticals, DEC 7, 2024, View Source [SID1234655963]).
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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-Eti. Two Phase I single-agent dose-escalation trials in solid tumors and one in lymphoma have been successfully completed in Australia and China. Single-agent data demonstrated favorable safety and tolerability, with single-agent anti-tumor efficacy observed in multiple indications, including lymphoma. Existing data support advancement to Phase II and combination trials. The company is currently conducting multicenter Phase II trials in multiple clinical indications. This poster presentation reported data from the ongoing Phase IB lymphoma program in the EBV+ NHL subgroup. HX009 demonstrated a favorable safety profile at a single dose of 10 mg/kg Q2W . Preliminary efficacy assessment in 14 patients with refractory/relapsed EBV+ NHL showed three partial responses and four sustained-release (SD) outcomes.
Dr. Henry Li, CEO/CSO of Hans Ait , and Dr. Zhang Lei, CMO, attended this year’s annual meeting and said, "We are very pleased to have the opportunity to report the results of this study to everyone at this annual meeting. Currently, there is no unified standard treatment for EBV+NHL. In clinical practice, the treatment of EBV+ and EBV- basically uses similar drugs with poor efficacy. In this clinical trial, we have observed that HX009 monotherapy can cause objective remission, suggesting the therapeutic potential of HX009 in this indication. We look forward to rapidly advancing this clinical trial and providing patients with new treatment options as soon as possible."