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CytoAgents Announces FDA Acceptance of IND Application for CTO1681 to Treat Cytokine Release Syndrome in Oncology

Friday, May 12, 2023

CytoAgents, Inc., a clinical-stage biotechnology company developing a safe, effective treatment for Cytokine Release Syndrome (CRS), today announced that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA). This clearance enables the initiation of a U.S. Phase 1b/2a clinical trial under its Investigational New Drug (IND) 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.

“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, RPh, CEO of CytoAgents. “The FDA’s clearance to advance our clinical program for CTO1681 in the U.S. is another important milestone for our company.”

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 has a clear path forward and a team ready to execute,” says 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.

About CytoAgents

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 (CRS), 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. We are committed to developing first-in-class, best-in-class products that meet major medical needs now and into the future. www.cytoagents.com

Forward Looking Statements

Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets, changes in governmental regulations and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. CytoAgents does not make any representation or warranty, express or implied, as to the accuracy, completeness, or updated status of such statements. CytoAgents will not be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.

Contacts
Kelley Skoloda for CytoAgents
412-897-3369
kskoloda@cytoagents.com

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