On October 20, 2021 HanX Biopharmaceuticals reported the latest clinical data for its recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, HanX Biopharmaceuticals, OCT 20, 2021, View Source [SID1234655941]). Professor Aflah Roohullah, the clinical lead PI at Southwestern Medical Center in Sydney, Australia, presented the favorable safety and tolerability clinical trial results of HX009 in an oral poster presentation.
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About the HX009 Australian Clinical Trial
Selected Study: First-in-Human Phase 1 Dose-Escalation Study of HX009, a Novel Recombinant Humanized Anti-CD47/PD-1 Bispecific Antibody, in Patients with Advanced Malignancies (Abstract No. 2517)
HX009 underwent a Phase I clinical study in Australia to evaluate the safety, tolerability, and pharmacokinetic (PK) properties of HX009 injection in patients with advanced solid tumors, and to assess its preliminary anti-tumor efficacy in solid tumors using the RECIST1.1 standard.
As of April 2021, enrollment in the seven dose-escalation cohorts in Australia has been completed, with a total of 21 patients enrolled. No dose-limiting toxicities or maximum tolerated doses have been observed, and safety and tolerability are good. Among the 20 patients who completed at least one tumor assessment, three patients (15%) achieved partial response (PR), with an objective response rate (ORR) of 15%, and seven patients (35%) achieved stable disease (SD), with a disease control rate (DCR) of 50%.
About HX009
HX009 Injection is a novel humanized antibody fusion protein injection independently developed by Hangzhou Hans. The HX009 antibody fusion protein simultaneously targets PD-1 and CD47. Through interaction between CD47’s ligand protein SIRPa and CD47 on tumor cells, it enhances macrophage phagocytosis and activates the immune response of CD8+ T cells. Anti-PD-1 antibodies then stimulate the replication of previously exhausted T cells, thereby enhancing both innate and cellular immune responses through multiple steps.