Shanghai I-Mab (NSDQ: IMAB) will start the second part of its US Phase I trial of TJM2 in patients with cytokine release syndrome (CRS) associated with severe COVID-19. TJM2, developed by I-Mab to treat rheumatoid arthritis, is a neutralizing antibody for human granulocyte-macrophage colony stimulating factor (GM-CSF), which plays a critical role in tissue inflammation. After completing a safety review, the trial's data monitoring committee recommended the continuation of the double-blind study at the higher 6 mg/kg dose level. Part 2 of the trial will enroll 144 patients who will receive either TJM2 or a placebo.

Part 1 of the test evaluated the safety and tolerability of TJM2 in a total of 24 patients who were randomized at a ratio of 1:1:1 to receive either a single dose of 3 mg/kg TJM2, a single dose of 6 mg/kg TJM2 or placebo of standard care, administered by intravenous (IV) infusion. The DMC concluded that I-Mab can start the Part 2 of the study as planned, indicating TJM2 is safe and well-tolerated in severe COVID-19 patients. The DMC also recommended broadening the inclusion criteria as well as the higher dose level.

I-Mab pointed out that the trial, with its double-blind, placebo-controlled, randomized design, is one of the first to evaluate the efficacy of an anti-GM-CSF antibody in patients with severe COVID-19.

"I-Mab's carefully planned clinical trial of its novel anti-GM-CSF agent brings potential new hope to effectively treat severe SARS-CoV-2 infection by suppressing uncontrolled inflammation", said Dr. Marcel Curlin, MD, Associate Professor, Department of Medicine, Division of Infectious Diseases, Oregon Health and Sciences University. "Preliminary results and positive review from the DMC are encouraging, and if we now begin to see an efficacy signal, we will have a powerful new approach to treating severe disease due to COVID-19."

Dr. Jingwu Zang, MD, PhD, Founder and Honorary Chairman and Director of I-Mab said, "As an innovative global biotech company, I-Mab has a responsibility to help address the urgent global health crisis. Since the outbreak took place, we sprang into action to prioritize TJM2 in response to the urgent medical needs. It is clear that the rationale and expectation of our study is further supported by the preliminary and encouraging evidence from other pilot studies with GM-CSF antibody class for this clinical indication."

"We appreciate DMC's assessment and positive recommendation which is a testament to I-Mab's science-focused clinical development capabilities," said Dr. Joan Shen, MD, PhD, CEO of I-Mab. "We are committed to conducting a robust clinical trial to the highest standards and we believe we have the most advanced anti-GM-CSF study in COVID-19 that could potentially lead to registration of TJM2 in the U.S. The DMC's confirmation of TJM2's safety profile bolsters the drug's potential to address the complications among the severe and critically ill – and ultimately save lives."

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Disclosure: none.