ImmuneOnco Biopharmaceuticals (Shanghai) Inc. confirmed that the inaugural patient has received a dose in the Phase II/III clinical trial (CTR20262001) assessing IMM0306 for IgG4-related disease (IgG4-RD).

The multicentre study will measure IMM0306’s ability to lower relapse risk in IgG4-RD patients as its primary endpoint, with secondary objectives covering safety, tolerability, population pharmacokinetics and immunogenicity. Participants receive an intravenous infusion once a week for four consecutive weeks, with a repeat treatment course at week 27.

IgG4-RD is a chronic fibro-inflammatory condition that can impair multiple organs and carries high relapse rates under current immunosuppressive regimens. Inebilizumab remains the only approved biologic option, leaving a significant unmet therapeutic need.

IMM0306—developed entirely in-house and protected by global intellectual-property rights—is the world’s first bispecific antibody to reach clinical trials that simultaneously targets CD47 and CD20. By blocking the CD47-SIRPα “don’t-eat-me” signal and enhancing Fc-mediated activation of macrophages and NK cells, while preferentially binding CD20 on pathogenic B cells, the molecule is designed to improve efficacy and limit toxicity.

The company notes that development and commercialisation of IMM0306 remain subject to clinical success and regulatory approvals, and advises shareholders and prospective investors to exercise caution when dealing in its shares.