IMMUNEONCO-B (ASX: 01541) has announced the successful administration of the first patient dose in its Phase II/III clinical trial for IMM0306 in the treatment of IgG4-Related Disease (IgG4-RD).

IgG4-RD is a chronic, progressive fibro-inflammatory condition that can affect multiple organ systems, including the pancreas, bile ducts, salivary glands, lacrimal glands, and retroperitoneal tissue. In severe cases, the disease may 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, indicating a significant unmet clinical need remains.

Research indicates that abnormal B-cell activation and infiltration of IgG4-positive plasma cells are central to the pathology of IgG4-RD, a mechanism that aligns closely with the mode of action of IMM0306.

The Phase II/III clinical trial, registered under CTR20262001, is designed to evaluate the efficacy of IMM0306 in reducing the risk of disease relapse in patients with IgG4-RD, which serves as the primary endpoint.

Secondary endpoints focus on assessing the drug's safety, tolerability, population pharmacokinetics, and immunogenicity.

Trial participants will receive weekly intravenous infusions for four consecutive weeks, with the dosing regimen repeated at week 27.