China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate, 9MW3811. This molecule is an in-house developed IL-11 monoclonal antibody (mAb) intended for the treatment of idiopathic pulmonary fibrosis (IPF).
Therapeutic Potential of 9MW3811 in Fibrosis and Oncology
9MW3811 has demonstrated the ability to effectively block the activation of the downstream signal pathway of IL-11, which contributes to its therapeutic effects on fibrosis and tumors. Research indicates that IL-11 is up-regulated in invasive lung fibroblasts in patients with IPF. Moreover, IL-11 plays a role in tumorigenesis, including cell proliferation, angiogenesis, and cell apoptosis. Studies based on multiple solid tumor models have shown that the combination of 9MW3811 and anti PD-1 antibodies can achieve effective anti-tumor treatment effects.
Preclinical Success and Safety Profile
In preclinical studies focusing on fibrosis diseases, 9MW3811 has significantly reduced the area of pulmonary fibrosis, decreased lung collagen content, and improved lung function in fibrosis model mice. This drug has already obtained clinical trial approval in Australia in February of this year, with early data indicating a good safety profile.-Fineline Info & Tech
