Therapy Areas: Inflammatory Diseases
CytoAgents Receives FDA Acceptance of IND Application for CTO1681 to Treat Cytokine Release Syndrome in Oncology
16 May 2023 - - US-based clinical-stage biotechnology company CytoAgents, Inc has received a Study May Proceed letter from the US Food and Drug Administration, the company said.

This clearance enables the initiation of a US Phase 1b/2a clinical trial under its Investigational New Drug application for the therapeutic, CTO1681, to treat 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 for their cancer experience CRS and associated neurotoxicity.

CytoAgents is developing innovative pharmaceutical products to treat life-threatening conditions, diseases and disorders associated with CRS.

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 in the oncology space such as CAR T-Cell and Bispecific Antibody Therapies suffer from high incidence of associated CRS. The condition can be lethal and requires hospitalization for adequate control in nearly all cases.

The company expects that effective CRS management will support greater accessibility to and broader adoption of these highly effective therapies in the clinic.

Building on this news, the company also announced the initial closing of its second equity round of financing.

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

CytoAgents is a privately held, clinical-stage biotechnology company focused on the development of innovative pharmaceutical products for the treatment of life-threatening symptoms associated with Cytokine Release Syndrome, an overreaction of the immune system causing systemic inflammation.

There are many causes of CRS, and our mission is to develop a broadly accessible treatment for multiple indications of high unmet need, including oncology CAR T-cell therapy and Bispecific Antibody Therapies, as well as COVID-19, and respiratory epidemics.

Using a novel, host-directed approach, our lead compound, CTO1681, targets the underlying cause of life-threatening CRS, by modulating the body's natural immune response to sickness or disease.
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