Hanx Biopharmaceuticals’ HX009 Receives US IND Approval for Lymphoma Treatment

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Wuhan-based firm Hanx Biopharmaceuticals Inc. has announced the receipt of an Investigational New Drug (IND) approval in the US for its anti-CD47/PD-1 bispecific antibody (BsAb), HX009. The molecule is set to be assessed in a Phase Ib/II study for patients with relapsed/refractory lymphoma who have failed standard therapy.

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HX009’s Clinical Trials in Australia and China
HX009 has already entered trials in Australia and China, focusing on both solid tumor and lymphoma indications. The bispecific antibody targets CD47 and PD-L1, which are key innate and adaptive immune checkpoints that coordinate the suppression of the immune system in relation to tumor cells. By dual-targeting both checkpoints, HX009 increases cytosolic DNA sensing in dendritic cells (DCs), thereby generating anti-tumor T cell responses.

Competition in the CD47/PD-1 BsAb Space
Other companies are also developing CD47/PD-1 BsAbs, including Innovent Biologics Inc. (HKG: 1801), ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd, (HKG: 1541) and Bio-Thera Solutions Ltd (SHA: 688177). This competitive landscape indicates the significant interest in advancing immunotherapies that can effectively target multiple immune checkpoints to enhance anti-tumor responses.-Fineline Info & Tech

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