ImmuneOnco secures FDA IND clearance for Phase Ib/II study of dual-targeting antibody IMM0306 in systemic lupus erythematosus

Bulletin Express

08/21

Hong Kong-listed ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (IMMUNEONCO-B, 01541) reported that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for IMM0306, authorising a Phase Ib/II clinical trial in systemic lupus erythematosus (SLE).

IMM0306 is a bispecific molecule that simultaneously targets CD47 and CD20. By blocking the CD47-SIRPα “don’t eat me” signal and enhancing Fc-mediated activation of macrophages and natural killer cells, the agent is designed to eliminate malignant B-cells while limiting toxicity. According to the company, IMM0306 is the first CD47/CD20 dual-targeting bispecific antibody to enter clinical development worldwide, and ImmuneOnco retains full global intellectual property and commercial rights.

The announcement, dated 21 August 2026, is voluntary under Hong Kong listing rules. The company reiterates that successful development or commercialisation of IMM0306 is not assured and advises shareholders and potential investors to exercise caution when dealing in its shares.

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