FDA approves study into CAR-T associated cytokine storm


The US Food and Drug Administration (FDA) has given the go-ahead to CytoAgents to initiate a US Phase Ib/IIa clinical trial investigating CTO1681 for cytokine release syndrome (CRS) in lymphoma patients receiving CAR-T cell therapy.

This is an area of great unmet medical need as the majority of patients undergoing CAR-T treatment experience CRS and associated neurotoxicity.

“We are thrilled to advance CTO1681 into the clinic and excited about how our novel therapeutic will potentially prevent and/or treat CRS,” said Teresa Whalen, CEO of CytoAgents. “The FDA’s clearance to advance our clinical programme for CTO1681 in the US is another important milestone for our company.”

Commonly referred to as cytokine storm, CRS is caused by excessive cytokine production and can be triggered by a range of diseases and treatments. Certain advanced immunotherapies such as CAR T-Cell and bispecific antibody therapies suffer from high incidence of associated CRS.

The company has also announced the initial closing of its second equity round of financing. “CytoAgents has a clear path forward and a team ready to execute,” said Brian Shanahan, Managing Partner, PCG Capital. “We are excited to support the acceleration of CytoAgents’ clinical development efforts and look forward to generating meaningful clinical data in patients.”

CytoAgents anticipates the clinical trial to launch at its first trial site in the summer of 2023.

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