CytoAgents Announces Initiation of Patient Enrollment in Phase 1b/2a Clinical Trial to Treat Cytokine Release Syndrome in CAR T-cell Therapy

PITTSBURGH--(BUSINESS WIRE)--CytoAgents, Inc., a clinical-stage biotechnology company developing a safe, effective treatment for Cytokine Release Syndrome (CRS), today announced that it has initiated recruitment and will enroll its first patient at UPMC Hillman Cancer Center, in the Phase 1b/2a clinical trial evaluating the therapeutic, CTO1681, to treat CRS in lymphoma patients receiving CAR T-cell Therapy.

“This clinical trial (CTA-2101) addresses an area of great unmet medical need as the majority of patients receiving CAR T-cell Therapy experience the toxicities of CRS and associated neurotoxicity,” said Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at CytoAgents.

The clinical trial will be conducted at multiple U.S. sites, with UPMC Hillman Cancer Center now the initial enrolling site. The trial investigates the safety, tolerability, and efficacy of different doses of CTO1681 in lymphoma patients receiving CAR T-cell therapy.

“We were early adopters of CAR T-cell therapy and remain committed to providing this treatment for our patients in the safest way possible,” said Robert L. Ferris, M.D., Ph.D., a physician-scientist, and director of UPMC Hillman Cancer Center. “We are dedicated to solving the CRS problem associated with CAR T-cell therapy and to be a part of this clinical trial at our institution.”

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

“We are thrilled to advance CTO1681 into the clinic to establish key insights into the safety and efficacy of our novel therapeutic,” said Teresa Whalen, RPh, CEO at CytoAgents. “Dosing our first patients in the lymphoma population is an important step forward for the company and the patients who may benefit. We look forward to continued enrollment with data anticipated in 2024.”

Details of the CTA-2101 trial can be found at www.clinicaltrials.gov under the identifier NCT05905328.

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

About Cytokine Release Syndrome (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 have a high incidence of associated CRS. CRS causes an overwhelming inflammatory reaction which requires hospitalization and, in some cases, can be life-threatening. Effective CRS management will support greater accessibility to and broader adoption of these highly effective therapies in the clinic.

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.