I-Mab announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application (IND) to initiate clinical study for TJM2 to treat cytokine release syndrome (CRS) associated with severe illness caused by the coronavirus disease 2019 (COVID-19). The Company has also obtained central institutional review board (IRB) approval from the Western Institutional Review Board on the same day. TJM2, also known as TJ003234, 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.

Upon the FDA IND clearance, the Company may proceed with the study in the United States. The proposed clinical trial is a multi-center, randomized, double-blind, placebo-controlled, three-arm study to evaluate the safety, tolerability and efficacy of TJM2 in reducing the severity of complications as well as levels of multiple cytokines in patients with severe COVID-19.

"With the IND approval, we will be able to rapidly explore the potential of TJM2 in preventing and treating CRS associated with COVID-19 and help address the immediate needs of the significant numbers of patients becoming severe in the current pandemic," said Dr. Joan Shen, CEO of I-Mab. "We are preparing for clinical trial initiation in the U.S. as soon as possible in order to join the fight against COVID-19 with our proprietary drug, in hope of reducing the morbidity and mortality caused by this illness."

I-Mab has plans to expand the study into other hard-hit countries. On March 30, 2020, I-Mab announced submission of an Investigational New Drug (IND) application to South Korea’s Ministry of Food and Drug Safety (MFDS), to evaluate the safety and efficacy of TJM2 in treating CRS in severe COVID-19 patients in South Korea.

The results from the planned study in the United States 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.

According to the WHO, as of April 2, 2020, there were more than 896,450 confirmed cases and more than 45,526 deaths related to SARS-CoV-2 infection globally. Severe and critically ill patients account for approximately 20% of all diagnosed patients.

TJM2 is an internally discovered neutralizing antibody against human GM-CSF, an important cytokine that plays a critical role in chronic inflammation and destruction in autoimmune diseases such as RA. 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. It is evident that GM-CSF plays a crucial role in the pathogenesis and disease progression of multiple autoimmune conditions.

TJM2 specifically 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. As a result, it 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 clinic trials in China in 2020.

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