A computer-generated representation of Covid-19 virions (SARS-CoV-2) under electron microscope. Credit: Felipe Esquivel Reed.

I-Mab Biopharma has filed an investigational new drug (IND) application with South Korea’s Ministry of Food and Drug Safety (MFDS) to conduct a clinical trial of TJM2 for the treatment of cytokine storm in patients with severe or critical Covid-19 infection.

Cytokine storm is the immune system’s overreaction to the viral infection and leads to clinical complications in severe and critically ill Covid-19 patients.

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Granulocyte-macrophage colony-stimulating factor (GM-CSF) levels are observed to be elevated in the plasma of infected patients with cytokine storm.

TJM2 is a monoclonal antibody designed to neutralise GM-CSF.

The planned single-arm, open-label pilot clinical trial will assess the ability of TJM2 in decreasing cytokine levels, including GM-CSF, in people with severe SARS-CoV-2 infection in South Korea.

I-Mab Biopharma CEO Dr Joan Shen said: “Recent data, including safety, pharmacokinetic (PK) and pharmacodynamic (PD) results generated from a previous single ascending dose study, preclinical studies, and research by the medical and scientific community studying Covid-19-associated CS will provide science-based rationale and solid evidence to help us further explore the potential of TJM2 as an innovative treatment for CS.”

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Earlier this month, the company launched a similar programme in the US to develop TJM2 for treating Covid-19-related cytokine storm.

According to data from a completed Phase I single ascending dose trial in the US, the drug candidate demonstrated favourable safety, tolerability, PK/PD and immunogenicity profiles.

China’s National Medical Products Administration cleared an IND to perform a Phase Ib trial of TJM2 in rheumatoid arthritis (RA) patients.

The proposed Covid-19 study will assess the drug candidate as a potential treatment to decrease or prevent cytokine storm and neurotoxicity caused by the CAR-T therapy.