I-Mab Biopharma is initiating the development of TJM2 to treat cytokine storm associated with severe and critical illness caused by Covid-19.
TJM2 is an I-Mab-discovered neutralising 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 begin following the US FDA acceptance of I-Mab’s Investigational New Drug (IND) application, and the study will commence initially in the US with plans to expand into other hardest-hit countries.
The company has successfully completed a Phase I single ascending dose (SAD) study of TJM2 in the US in which TJM2 has exhibited favourable safety, tolerability, PK/PD, and immunogenicity profiles.
Cytokine storm is characterised 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 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, which account for approximately 20% of all patients, especially in those requiring intensive care.
“Research data provide the rationale to use TJM2 as a potential treatment for cytokine storm associated with Covid-19, because the antibody effectively neutralises circulating GM-CSF to control acute inflammatory responses, and it may also exhibit potential advantages over conventional IL-6 antibodies, ” said Dr Joan Shen, CEO of I-Mab.
“This expanded IND application of TJM2 would allow us to act timely to help battle the global Covid-19 pandemic.”
The results from the planned Covid-19 study will be used to further evaluate the potential therapeutic role of TJM2 in reducing or preventing cytokine storm and neurotoxicity associated with CAR-T therapy.