A China-based clinical stage biopharmaceutical immuno-oncology and autoimmune diseases focused company, I-Mab Biopharma (I-Mab), said Monday it got the US Food and Drug Administration (FDA) has approval for its IND application for TJM2, a potential treatment for autoimmune and inflammatory diseases.
TJM2 is the first candidate from I-Mab’s pipeline, anti-GM-CSF monoclonal antibody TJM2, to be approved for clinical trials by the FDA.
GM-CSF is a critical pro-inflammatory cytokine that plays a pivotal role in tissue inflammation and destruction in autoimmune and inflammatory diseases. TJM2 will be tested in clinical trials for its potential as a new treatment option for diseases such as rheumatoid arthritis and osteoarthritis, I-Mab said.
I-Mab’s CEO, Jingwu Zang, said the IND approval from the FDA to start clinical studies with TJM2 in the United States is another important milestone for I-Mab’s global strategy. “(It is) a strong testament to I-Mab’s in-house research capability to develop highly innovative biologics for patients around the world,” Zang said.
The initial first-in-human (FIH) single dose study will look at safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of TJM2 in healthy volunteers (including Chinese subjects) in the United States.