I-Mab Biopharma, a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders, is initiating the development of TJM2 (TJ003234) to treat cytokine storm associated with severe and critical illness caused by the coronavirus disease (COVID-19).

 

TJM2 is an I-Mab-discovered neutralizing antibody against human granulocyte-macrophage colony stimulating factor (GM-CSF), an important cytokine that plays a critical role in acute and chronic inflammation. 

The development will start following the U.S. Food and Drug Administration’s (FDA) acceptance of I-Mab’s Investigational New Drug (IND) application, and the study will commence initially in the United States with plans to expand into other hardest-hit countries. 

Cytokine storm is characterized by surge of high levels of circulating inflammatory cytokines, and is an overreaction of the immune system under the conditions, such as CAR-T therapy [1] and patients with severe COVID-19. Recent studies revealed that high levels of GM-CSF, along with a few other cytokines, are critically associated with severe clinical complications in COVID-19 patients. High concentration of GM-CSF was found in the plasma of severe and critically ill patients [2], which account for approximately 20% of all patients [3], especially in those requiring intensive care.