Amulirafusp alfa (IMM0306), developed on ImmuneOnco’s proprietary "mAb-Trap" technology platform, is a novel MCE molecule simultaneously targeting CD47 and CD20. It is the first-in-class myeloid cell engager (MCE) to enter clinical development for systemic lupus erythematosus (SLE).The clinical data of IMM0306 in oncology has robustly validated its favorable efficacy and safety profile in B-cell malignancies, providing a strong foundation for its expansion into B-cell–mediated autoimmune diseases.

The FDA's IND clearance is supported primarily by positive data from the Company's Phase Ib/II clinical trial of IMM0306 in Chinese patients with moderate-to-severe active SLE. Preliminary results presented at the 2026 European Congress  of Rheumatology (EULAR) demonstrated that IMM0306 achieves profound B-cell depletion with durable clinical efficacy. In the 1.6 mg/kg cohort, the SRI-4 response rate reached 80% at Week 24. Notably, no dose-limiting toxicities (DLTs), no treatment-related serious adverse events (SAEs) or cytokine release syndrome (CRS) were observed across the 0.8–2.0 mg/kg dose range, underscoring a compelling safety advantage. This FDA clearance will enable ImmuneOnco to initiate a Phase Ib/II clinical trial in SLE patients in the United States, further evaluating the efficacy and safety of IMM0306 in a global patient population.

Beyond SLE, ImmuneOnco’s autoimmune pipeline continues to advance in other major autoimmune indications — including IgG4-related disease and primary membranous nephropathy.

"As an innovative bispecific fusion protein targeting both CD47 and CD20, IMM0306 precisely engages pathogenic B cells through a dual mechanism of action, enabling highly efficient clearance of disease-driving cells. The clinical data presented at the 2026 EULAR Congress have convincingly demonstrated that IMM0306 induces profound B-cell depletion and reshapes the immune microenvironment, while delivering strong clinical efficacy and a favorable safety profile.

"The FDA’s clearance of this Phase Ib/II clinical trial in SLE affirms the recognition by a leading international regulatory authority of IMM0306’s preliminary clinical data, innovative mechanism of action, and clinical value in the treatment of SLE, laying a solid foundation for the program’s subsequent global clinical development and commercialization.

"Going forward, we will remain committed to steadily advance the clinical development of IMM0306 and maintain stringent standards for data quality and safety. Our goal is to accelerate the clinical translation of this breakthrough innovative therapy, to bring a safer, more effective, and more convenient treatment option to SLE patients worldwide as soon as possible, helping to improve patient survival and quality of life."