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Friday, March 13, 2020

I-Mab Develops TJM2 to Treat Syndrome Tied to Severe Coronavirus Disease

I-Mab Biopharma (Nasdaq: IMAB), (“I-Mab” or the “Company”), 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, today announced that it is initiating the development of TJM2 (TJ003234) to treat cytokine storm in severe and critically ill patients 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 infected with SARS-CoV-2. 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.
“Research data provide the rationale to use TJM2 as a potential treatment for cytokine storm associated with COVID-19, because the antibody effectively neutralizes circulating GM-CSF to control acute inflammatory responses, and it may also exhibit potential advantages over conventional IL-6 antibodies [4], ” 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 Company has successfully completed a Phase I single ascending dose (SAD) study of TJM2 in the United States (NCT03794180), in which TJM2 has exhibited favorable safety, tolerability, PK/PD, and immunogenicity profiles. TJM2 also received IND clearance from China’s National Medical Products Administration for a multiple-dose Phase 1b study in patients with rheumatoid arthritis (RA). The results from the planned COVID-19 study will also be used to further evaluate the potential therapeutic role of TJM2 in reducing or preventing cytokine storm and neurotoxicity associated with CAR-T therapy.
https://www.biospace.com/article/releases/i-mab-biopharma-announces-development-of-tjm2-to-treat-cytokine-release-syndrome-associated-with-severe-and-critically-ill-patients-with-coronavirus-disease-covid-19-/

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