I-Mab (Nasdaq: IMAB) announced that the U.S. Food and Drug Administration has cleared its investigational new drug application (IND) to initiate a clinical study for TJM2 to treat cytokine release syndrome (CRS) associated with severe illness caused by COVID-19. The company secured central institutional review board (IRB) approval from Western Institutional Review Board as well. TMJ2 (TJ003234) is an I-Mab-discovered neutralizing antibody against human granulocyte-macrophage colony stimulating factor (GM-CSF), an important cytokine that is a key player in acute and chronic inflammation.
According to the World Health Organization (WHO), as of April 2, 2020, there were over 896,450 confirmed cases of SARS-CoV-2 and over 45,526 deaths related to the deadly pathogen worldwide. Severe and critically ill patients account for about 20% of all diagnosed patients.
What is TMJ2?
Developed internally, this neutralizing antibody against GM-CSF is an important cytokine that fits into an essential role in chronic inflammation and destruction in autoimmune diseases such as rheumatoid arthritis. GM-CSF can polarize macrophages into the pro-inflammatory M1 phenotype and is known to induce an inflammatory cascade involving other pro-inflammatory cytokines such as tumor-necrosis factor (TNF), interleukin-1 (IL-1), IL-6, IL-12, and IL-23. The company notes, it is apparent that GM-CSF plays an important role in the pathogenesis and disease progression of multiple autoimmune conditions.
TJM2 binds to human GM-CSF with high affinity and can block GM-CSF from binding to its receptor, thereby preventing downstream signaling and target cell activation. Hence the target can effectively inhibit inflammatory responses mediated by macrophages, neutrophils and dendritic cells leading to reduced tissue inflammation and damage. TJM2 is expected to be the first antibody of its class to enter clinical trials in China in 2020.
FDA Greenlights Clinical Trial
As the FDA cleared the IND, now I-Mab can proceed with a proposed clinical trial in the United States. This proposed clinical trial, a multi-center, randomized, double-blind, placebo controlled and three-armed study will evaluate the safety, tolerability, and efficacy of TMJ2 in reducing the severity of complications as well as levels of multiple cytokines in patients with severe COVID-19.
Study Expanded in Hard-Hit countries
I-Mab will expand the study into countries that have been hard-hit by the novel coronavirus. I-Mab filed an IND in Korea, for example, to conduct clinical trials there as well.
What is their Goal?
I-Mab seeks to take the results from the U.S. study and further evaluate the potential therapeutic role of TJM2 in reducing or preventing cytokine storm and neurotoxicity associated with CAR-T therapy.
Who is I-Mab?
Founded in 2016, the Shanghai-based Chinese company has about 200 employees, they are developing innovative biologics or first-in-class or best-in-class potential in the therapeutic areas of immuno-oncology and autoimmune diseases. Well recognized by the capital markets, they have raised over $400 million in equity financing since their inception. Its recent $200 million Series C financing represents one of the largest amounts ever raised by a biotech venture in China. By January 2020, they announced their IPO.
Their investors have included Tally Capital, HOPU Investment Management Company, Tasly Pharmaceutical, Hony Capital, Ally Bridge Group, CDH Investment, Hillhouse Capital Group, EDBI, C-Bridge Capital, and Genexine.