CytoAgents has received approval from the US Food and Drug Administration (FDA) for an investigational new drug (IND) application in oncology.

The FDA’s Study May Proceed letter gives clearance for CytoAgents to begin a Phase Ib/IIa clinical trial of CTO1681 to treat cytokine release syndrome (CRS).

The company’s lead compound, CTO1681, targets the underlying cause of CRS by modulating the natural immune response of the body to sickness or disease.

Lymphoma patients who are receiving CAR T-Cell therapy will be enrolled in the study.

CRS is caused by excessive cytokine production and can be triggered by various diseases and treatments, including CAR T-Cell and bispecific antibody therapies.

Almost all cases of CRS can be lethal and the condition requires hospitalisation for adequate control.

CytoAgents expects that effective CRS management will increase the use of CAR T-Cell and bispecific antibody therapies in clinics by making them more accessible.

CytoAgents CEO Teresa Whalen said: “We are thrilled to advance CTO1681 into the clinic and excited about how our novel therapeutic will potentially prevent and/or treat CRS.

“The FDA’s clearance to advance our clinical programme for CTO1681 in the US is another important milestone for our company.”

CytoAgents plans to initiate the study at its first site this year.

The company has also reported the initial closing of its second equity round of financing.

The funding round saw participation from various investors, including investment firm PCG Capital.

PCG Capital managing partner Brian Shanahan said: “We are excited to support the acceleration of CytoAgents’ clinical development efforts and look forward to generating meaningful clinical data in patients.”

In addition to CAR T-cell therapies, CytoAgents aims to develop accessible treatments for various indications of high unmet need, including Covid-19 and respiratory epidemics.

Based in Pittsburgh, Pennsylvania, the company focuses on developing innovative pharmaceutical products to treat life-threatening symptoms associated with CRS.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

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