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IMM0306S + SOC is a therapeutic regimen consisting of the subcutaneous formulation of amulirafusp alfa (IMM0306) combined with standard of care (SOC) medications, such as oral corticosteroids, antimalarials, and/or immunosuppressive agents. Amulirafusp alfa is a first-in-class bispecific fusion protein developed by ImmuneOnco Biopharmaceuticals (through its subsidiary ImmuneCare). It is designed to simultaneously target CD47 and CD20, constructed from a CD20 monoclonal antibody fused with the CD47-binding domain of SIRPα. This dual-targeting mechanism blocks the CD47-SIRPα 'don't eat me' inhibitory signal while promoting B-cell depletion through the engagement of Fcγ receptors on macrophages and NK cells. The regimen is currently being evaluated in Phase 1b/II clinical trials for the treatment of active systemic lupus erythematosus (SLE), where it has demonstrated favorable safety and deep B-cell depletion.
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