On December 2, 2025 CytoAgents, Inc., a clinical-stage biotechnology company developing CTO1681, a novel, steroid sparing inhibitor of prostaglandin mediated inflammation, reported that preliminary safety data from its Phase 1b/2a clinical trial for its lead drug candidate, CTO1681, will be presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6-9, 2025, in Orlando, Florida.

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CTO1681 is an oral, small molecule immune modulator that uses a novel approach to prevent and mitigate both inflammation in the tumor microenvironment as well as toxicity frequently seen with lymphoma patients receiving CAR T-Cell Therapy. CytoAgents is currently enrolling patients in a Phase 1b/2a clinical trial evaluating CTO1681 in lymphoma patients receiving CAR T-Cell Therapy at risk for inflammatory driven toxicities.

At ASH (Free ASH Whitepaper), the company will present preliminary safety data from the first patient cohort of the Phase 1b/2a clinical trial. Among the key findings to be presented, CTO1681 was shown to be well tolerated at the 10μg three times a day (TID) dose. Importantly, no dose-limiting toxicities and no drug-related serious adverse events were observed in the cohort. Based on these positive findings, CytoAgents is currently enrolling the second cohort of the trial, an escalated dosage of 20μg TID.

"New approaches to treat inflammation in the tumor microenvironment as well as black box warning toxicities, Cytokine Release Syndrome (CRS) and the neurotoxicity ICANS, continues to be an area of significant unmet medical need, with the majority of cancer patients undergoing CAR T treatment experiencing CRS and associated neurotoxicity," said Teresa Whalen, Chief Executive Officer at CytoAgents. "We look forward to sharing this initial positive safety data for CTO1681 at ASH (Free ASH Whitepaper) and to continuing our advancement of CTO1681."

Poster Presentation Details

Title: A phase 1b/2a study of CTO1681 for the prevention of cytokine release syndrome in patients with diffuse large B-cell lymphoma receiving chimeric antigen receptor T-cell therapy
Presenter: Jordan Gauthier, MD, MSc, Associate Professor, Clinical Research Division, Fred Hutchinson Cancer Center, Clinical Research Division, Seattle, WA, USA
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
Publication Number: 5955
Session Date and Time: Sunday, December 7, 2025, 6:00 PM – 8:00 PM ET
Location: Orange County Convention Center – West Halls B3-B4

CytoAgents also announced that research from its Phase 1 study evaluating the safety, tolerability and pharmacokinetics of CTO1681 in healthy adult participants has been selected by ASH (Free ASH Whitepaper) for online publication. The abstract, entitled "A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of CTO1681 (GP1681) in Healthy Adult Participants", will be published online in the November supplemental issue of Blood and will become part of the permanent ASH (Free ASH Whitepaper) and Blood abstracts archive.

(Press release, CytoAgents, DEC 2, 2025, View Source [SID1234661044])