China-based I-Mab Receives FDA IND Approval for Anti-GM-CSF Monoclonal Antibody TJM2

Dec 26, 2018 | Autoimmune Disease, China, IND, Oncology

China Immunotherapy

I-Mab Biopharma is a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immune-oncology and autoimmune diseases. It recently announced its TJM2 humanized immunoglobulin G1 (IgG1) targeting granulocyte- macrophage colony-stimulating factor (GM-CSF) with the best in class potential to treat autoimmune and inflammatory diseases, was approved by the FDA for human clinical trials.  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. 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.

Who is I-Mab? Based in China, I-Mab has raised $370 million in at least three rounds of venture capital financing. They seek to address unmet needs in China and to bring innovative products to the world.  They report that they are on track to initiate clinical trials in China and the U.S.

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