I-Mab to kick off clinical trials for monoclonal antibody TJM2 in China
I-Mab Biopharma ("I-Mab"), a China and U.S.-based clinical-stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and autoimmune diseases have announced that National Medical Products Administration (NMPA) approved its IND application for TJM2 to conduct clinical trials in patients with rheumatoid arthritis (RA). TJM2 is a humanized immunoglobulin G1 (IgG1) neutralizing antibody targeting the cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) with the potential to treat patients with autoimmune and inflammatory diseases in which GM-CSF plays a critical role.
TJM2 is the first in-house developed drug candidate from I-Mab's global portfolio of internally developed candidates to have entered clinical trials. Earlier this year, I-Mab conducted a first-in-human phase 1 clinical trial with TJM2 in healthy volunteers in the U.S. (NCT03794180). Having successfully completed that trial, I-Mab filed an IND with the NMPA for TJM2 in patients with RA and, subsequently, received regulatory clearance on November 8. The current phase I study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of TJM2 in patients with RA.