beraprost isomer (CTO1681) / CytoAgents - LARVOL DELTA

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 (ASH 2025) - P1 | "The current standard-of-care treatment for CRS is tocilizumab and/or corticosteroids. Latent viruses (EBV, HSV, VZV, and CMV) were not detected in any participant, and there were no reports of skin lesions that might be indicative of viral reactivation. The PK, PD, and safety data presented in this clinical study report supports further clinical development of CTO1681."

Clinical • PK/PD data • Hypotension • Immunology • Infectious Disease • Influenza • Respiratory Diseases • Systemic Inflammatory Response Syndrome

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 (ASH 2025) - P1/2 | "The current standard-of-care treatment for CRS is tocilizumab and/or corticosteroids, thelatter being used for ICANS management. Phase 1b is an open-label, dose escalation study of up to 3 dosing level cohorts that beganenrolling patients in December 2023. Phase 2a is a randomized placebo-controlled study using therecommended Phase 2 dose identified in Phase 1b."

CAR T-Cell Therapy • Clinical • Cytokine release syndrome • P1/2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma

CytoAgents to Present New CTO1681 Data at the ESMO Immuno-Oncology Congress 2025 (Businesswire) - "At ESMO, the company will present data from two non-clinical studies demonstrating that CTO1681 attenuates key cytokines known to drive Cytokine Release Syndrome (CRS) without compromising the CAR T-Cell mediated tumor killing in vitro and in vivo. These studies demonstrate that CTO1681 does not interfere with CD19 CAR T-Cell expansion and anti-tumor activity in vivo while reducing the inflammatory cytokines associated with CRS and ICANS."

Preclinical • Hematological Malignancies

Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy (clinicaltrials.gov) - P1/2 | N=54 | Recruiting | Sponsor: CytoAgents, Inc. | Phase classification: P1b/2a ➔ P1/2

CAR T-Cell Therapy • Cytokine release syndrome • Phase classification • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CytoAgents Announces Initiation of Patient Enrollment in Phase 1b/2a Clinical Trial to Treat Cytokine Release Syndrome in CAR T-cell Therapy (Businesswire) - "CytoAgents, Inc...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...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 look forward to continued enrollment with data anticipated in 2024.'"

Cytokine release syndrome • Enrollment open • P1/2 data • Hematological Malignancies • Lymphoma • Oncology

Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy (clinicaltrials.gov) - P1b/2a | N=54 | Recruiting | Sponsor: CytoAgents, Inc. | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Cytokine release syndrome • Enrollment open • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

"#CytoAgents Announces #FDA Acceptance of #IND Application for #CTO1681 to Treat Cytokine Release Syndrome in #Oncology https://t.co/OScegsrle6" (@1stOncology)

Cytokine release syndrome • FDA event • Inflammation • Oncology

CytoAgents Announces FDA Acceptance of IND Application for CTO1681 to Treat Cytokine Release Syndrome in Oncology (Businesswire) - "CytoAgents...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....CytoAgents anticipates the clinical trial to launch at its first trial site in the summer of 2023."

IND • New P1/2 trial • Hematological Malignancies • Lymphoma • Oncology

CytoAgents Receives Second Round of NIH Funding to Accelerate Treatment for Cytokine Storm (Businesswire) - P1, N=NA; "CytoAgents...announced today that it has been awarded a $2 million National Institutes of Health (NIH) grant, the second NIH grant in a year....Nearing the completion of its Phase 1 clinical trial for COVID-19, GP1681 has demonstrated a strong safety profile, with no serious adverse events reported to date....Phase 2 clinical trials for COVID are slated to begin by mid-2021....The Phase II SBIR grant of $2 million...will advance the research of GP1681 through IND-enabling toxicology studies expanding the initial toxicology screens; Pharmacokinetic (PK) analysis in a non-human primate (NHP) model; and assessment of the efficacy of delayed GP1681 treatment in an NHP model of COVID-19."

Cytokine release syndrome • Cytokine storm • Financing • New P2 trial • P1 data • Infectious Disease • Novel Coronavirus Disease

New Coronavirus Drug (FOX 8) - "...GP1681 clinical trial is ongoing, focusing on the safety and dosage of the drug. 'We have successfully completed our first cohort with positive results. This has enabled us to go directly into cohort #2 we began dosing those patients just this very week,' she said....She said GP1681 is cost effective, estimating its cost to be in the hundreds, with easy access to the public....With proper funding, Whalen said they hope to start Phase 2 trials at the beginning of next year."

Cytokine storm • New P2 trial • Trial status • Infectious Disease • Novel Coronavirus Disease

CytoAgents Launches Clinical Trials for GP1681, Treatment of COVID-19 Cytokine Storm (Odessa American) - "CytoAgents...announced today that enrollment has started for its Phase 1 clinical trial with lead drug candidate, GP1681, for treatment of COVID-19 'cytokine storm'....A randomized, double-blind, placebo-controlled study to assess the safety and tolerability of GP1681 in healthy adults, the Phase 1 Trial, is being conducted in partnership with contract research organization, Novotech, and clinical trial unit, CMAX Clinical Research, in Australia. The company anticipates trial completion with results early in 2021, which will support the initiation of a Phase 2 Trial immediately thereafter."

Cytokine storm • Enrollment status • P1 data • Trial completion date • Infectious Disease • Novel Coronavirus Disease

CytoAgents Receives Funding to Accelerate COVID-19 Clinical Trials for Cytokine Storm Treatment From Richard King Mellon Foundation (Businesswire) - "CytoAgents...announced today that it has received an investment to accelerate the development of its lead drug candidate, GP1681, an investigational new drug to treat 'cytokine storm' induced by COVID-19, from the Richard King Mellon Foundation. The Program Related Investment is part of the foundation’s $25 million Pandemic Solutions Package to jump-start COVID-19 response strategies....The $250,000 investment will accelerate the development of GP1681, which will be going into Phase 1 and Phase 2 human clinical trials in 2020."

Cytokine storm • Financing • Infectious Disease • Novel Coronavirus Disease

Quotient Sciences and CytoAgents accelerate potential treatment for Covid-19 cytokine storm (BioSpace) - "A collaboration to accelerate the development of a lead COVID-19 drug candidate into human clinical trials was announced today by Quotient Sciences...and CytoAgents, Inc....The partnership will focus on utilizing Quotient’s integrated service portfolio to support the rapid development of CytoAgents’ lead COVID-19 drug candidate, GP1681, for Phase I and II in 2020....CytoAgents will access Quotient’s formulation and manufacturing expertise to develop and rapidly supply drug product....In parallel, Quotient will work to develop a scalable solid oral dosage form for larger patient trials and commercialization. The program will be conducted at Quotient’s facility..."

Licensing / partnership • New molecule • New P1 trial • New P2 trial • Infectious Disease • Novel Coronavirus Disease