China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that a clinical trial filing for its 9MW3911, a non-IL-2 blocking CD25 monoclonal antibody (mAb) developed via the high-efficiency B lymphocyte screening platform, has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication for this innovative therapy is advanced malignant tumors, marking a significant step in the development of novel cancer treatments.
Mechanism of Action
9MW3911 is designed to selectively clear regulatory T cells (Treg) that highly express CD25 through antibody-dependent cell-mediated cytotoxicity (ADCC). Unlike other therapies, 9MW3911 does not block the IL-2 signaling pathway, allowing it to regulate the tumor microenvironment and enhance tumor immunity without interfering with essential immune functions. This unique mechanism of action positions 9MW3911 as a promising candidate for improving patient outcomes in advanced cancer settings.
Preclinical Results and Future Outlook
Preclinical studies of 9MW3911 have produced positive signs of efficacy and safety, laying a strong foundation for its advancement into clinical trials. The acceptance of the clinical trial filing by the NMPA is a crucial milestone, paving the way for further investigation of 9MW3911’s potential in treating advanced malignant tumors. As the clinical trial progresses, Mabwell Bioscience will continue to evaluate the safety and efficacy of 9MW3911, with the goal of bringing this innovative therapy to patients in need.-Fineline Info & Tech
