IMMUNEONCO-B(01541): The first patient has been dosed in the Phase II/III clinical trial of IMM0306 for the treatment of IgG4-related diseases.

IMMUNEONCO-B(01541) announced that the phase II/III trial of IMM0306 for the treatment of IgG4-related diseases (IgG4-RD) has successfully dosed the first patient. IgG4-RD is a chronic, progressive fibroinflammatory disease that may affect multiple organ systems, including the pancreas, bile ducts, salivary glands, lacrimal glands, and retroperitoneal tissues. In severe cases, the disease can lead to organ failure. Current immunosuppressive treatments are limited by low response rates and high recurrence rates. Inebilizumab (an anti-CD19 monoclonal antibody) is currently the only approved biologic therapy, but there remains a significant unmet clinical need. Research has shown that abnormal B cell activation and IgG4-positive plasma cell infiltration are core pathologic mechanisms of IgG4-RD, which aligns closely with the mechanism of action of IMM0306. The phase II/III clinical trial (registration number: CTR20262001) aims to evaluate the efficacy of IMM0306 in reducing the risk of disease recurrence in IgG4-RD patients, with this as the primary endpoint. Secondary endpoints focus on evaluating the drug's safety, tolerability, population pharmacokinetic characteristics, and immunogenicity. Subjects will receive a weekly intravenous infusion for four consecutive weeks, with a repeat dosing regimen at Week 27.