CytoAgents Announces Completion of Cohort 1 Dose-escalation Stage of Clinical Phase 1B to Advance Research on Cytokine Release Syndrome

CytoAgents Inc., a clinical-stage biotechnology company developing CTO1681 for the prevention and treatment for Cytokine Release Syndrome (CRS), announced the successful completion of the first dose, core cohort dose-limiting toxicity observation period in its ongoing Phase 1b/2a clinical trial. Following a review of safety and efficacy data, the Safety Review Committee (SRC) has approved dose-escalation to the next, higher planned dose in Cohort 2.

“This milestone marks an important step forward in our mission to deliver a safe, effective therapy for Cytokine Release Syndrome,” said Teresa Whalen, RPh, CEO of CytoAgents. “We remain focused on advancing through the next stages of this trial and ultimately delivering a much-needed treatment option for patients facing this life-threatening immune response.”

The first-dosing cohort included patients with Diffuse Large B-Cell Lymphoma (DLBCL) receiving CAR T-Cell Therapy at risk for CRS. Current data from this cohort demonstrated a favorable safety profile, with no dose limiting toxicities (DLTs) or drug-related serious adverse events (SAEs) observed. Additionally, no interference with the CAR T-Cell Therapy was observed.

The trial, NCT05905328, is an open-label, dose-escalation, multi-center study designed to evaluate the safety, tolerability, and preliminary efficacy of CTO1681 in DLBCL patients receiving CAR T-Cell Therapy at risk for CRS. The trial follows a standard, rolling six dose-escalation design, with the goal of evaluating the safety profile, the pharmacokinetics of CTO1681, and determining the Recommended Phase 2 Dose (RP2D).

“The safety and early efficacy data from the first dose cohort are encouraging,” said Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer of CytoAgents. “We look forward to evaluating the higher dose cohorts to further study the potential of CTO1681 to prevent and treat CRS, a very significant toxicity of CAR T-Cell Therapy.”

CTO1681 is an investigational new drug that uses a novel approach to prevent and mitigate Cytokine Release Syndrome in patients receiving CAR T-Cell Therapy. This is an area of significant unmet medical need, as the majority of patients undergoing CAR T-Cell Therapy for their cancer experience CRS and associated neurotoxicity.

About CytoAgents

CytoAgents Inc. 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 CRS triggered by CAR T-Cell and Bispecific Antibody Therapies, as well as respiratory epidemics and autoimmune illnesses. 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.

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“This milestone marks an important step forward in our mission to deliver a safe, effective therapy for Cytokine Release Syndrome,” said Teresa Whalen, RPh, CEO of CytoAgents.