Mabwell Receives U.S. FDA Approval of Clinical Trial Application for 9MW3811
Friday, June 16, 2023
Mabwell has announced the clinical trial application of the self-developed injection called 9MW3811 for the treatment of idiopathic pulmonary fibrosis (IPF). This injection has been approved by the United States Food and Drug Administration (FDA).
9MW3811 is the China's first anti-IL-11 monoclonal antibody to receive approval for clinical study and has also obtained IND clearance in three countries: Australia, China, and the United States.
9MW3811 is a humanised monoclonal antibody designed to target human interleukin-11 (IL-11), a protein involved in various pathophysiological processes, including fibrosis and tumour development. By blocking the activation of the downstream signalling pathway of IL-11, 9MW3811 aims to inhibit the harmful effects induced by IL-11 and provide therapeutic benefits for fibrosis and tumours.
In preclinical studies, 9MW3811 demonstrated high affinity binding to IL-11, effectively blocking its signalling pathway activation. Additionally, it showed specific regulation of the interaction between tumour cells and various immune cells, such as T cells, macrophages, and tumour-associated fibroblasts.
This regulation resulted in enhanced release of inflammatory cytokines in the tumour microenvironment and increased infiltration of T cells. Furthermore, in combination with anti-PD1 antibodies, 9MW3811 exhibited promising anti-tumour efficacy in various solid tumour models.
