China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving clinical trial approval from the Therapeutic Goods Administration (TGA) of Australia for its 9MW3811, an in-house developed IL-11 monoclonal antibody (mAb) for the treatment of various advanced malignant tumors and fibrotic diseases. This approval marks a significant step forward in the development of innovative therapies for these conditions.
9MW3811: Mechanism of Action and Therapeutic Potential
9MW3811 is the first of its kind to enter clinical trials. It can effectively block the activation of the downstream signal pathway of IL-11, thus achieving a therapeutic effect on fibrosis and tumors. Studies have shown that IL-11 is up-regulated in invasive lung fibroblasts of patients with idiopathic pulmonary fibrosis. Additionally, IL-11 is involved in the process of tumorigenesis, including cell proliferation, angiogenesis, and cell apoptosis.
Phase I Study Design
The approved randomized, double-blind, placebo-controlled Phase I study (NCT05740475) is expected to enroll 32 healthy subjects. The primary endpoints of the study include the incidence of adverse events evaluated by CTCAE v5.0, the number of subjects with abnormal physical examination results of clinical significance, and the number of subjects with abnormal clinical vital signs.
Strategic Implications
The TGA’s approval for the clinical trial of 9MW3811 highlights Mabwell Bioscience’s commitment to advancing its pipeline of innovative therapies. By targeting IL-11, 9MW3811 has the potential to address significant unmet medical needs in the treatment of fibrotic diseases and advanced malignant tumors. This development is expected to enhance Mabwell’s position in the global biopharmaceutical market and contribute to the advancement of personalized medicine.-Fineline Info & Tech
