Unregulated Inflammation:

Drives Illness Across a Pipeline of Indications

Our Solution

CytoAgents is focused on rebalancing the immune system to reduce the destructive impact of unregulated inflammation while leaving necessary immune function intact. CTO1681, a potent prostaglandin inhibitor treats the key drivers of inflammation by blocking PGE2 signaling and the NF-κB pathway which plays a critical role in activating and regulating inflammatory immune cells. By interrupting this pathway, CTO1681 effectively blocks cytokine amplification, downregulating cytokine production while leaving the immune system functionally intact. This novel approach has certain advantages over other treatments strategies, namely:

  • CTO1681 affects a broad range of cytokines, therefore is unlikely to be circumvented by redundant signaling pathways
  • CTO1681 can be used to mitigate inflammation in the tumor microenvironment as well as to prevent and treat CRS & ICANS.
  • CTO1681 is a small molecule oral treatment, which offers cost-advantages and a broader range of delivery options
Our Science

UNREGULATED CYTOKINE PRODUCTION DRIVES RAPID ONSET OF CRS AND ICANS IN CAR T PATIENTS:

Two Consequences of Unregulated Inflammation

Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) are primary toxicities of CAR T and TCE therapies. Both are driven by excessive prolonged cytokine production, which leads to dangerous and potentially life-threatening systemic inflammation. Up to 95% and 60% of CAR T and TCE patients, respectively, experience CRS. And practically all ICANS cases are preceded by CRS. It is widely accepted among clinicians that effectively eliminating CRS will also prevent subsequent development of ICANS.

Hyperactivation of the immune system causes inflammation in the tumor microenvironment (TME) limiting efficacy of cell therapies, and triggers life threatening treatment-related toxicities as well. PGE2 signaling has been implicated as a key driver of inflammation in the TME potentially limiting the effectiveness of cell therapy.

CRS and ICANS
Major Barriers to CAR T & TCE Adoption

High Incidence
  • Up to 95% of CAR T & Up to 60% of TCE develop CRS
  • Up to 99% of ICANS patients experienced prior CRS
Inadequate SOC
  • 50-80% of patients treated with Tocilizumab require high dose steroids
  • Tocilizumab may increase risk of ICANS 1
  • Steroids increase vulnerability to infection and may impact overall survival outcomes 2
High Costs
  • Average 12-14 days of hospitalization
  • 33% patients transferred to ICU
Low Adoption
  • Access limited to academic centers
  • <10% cancer care centers offer CAR T or TCE therapies 4
  • 7 out of 10 eligible patients cannot access treatments
7 out of 10
Eligible Patients Cannot Access CAR T-Cell or TCE Therapies
<10%
Cancer Care Centers Offer CAR T-Cell or TCE Therapies
400+
CAR T-Cell and TCE Therapies Currently in Clinical Development

CTO1681 REMOVES PATIENT ACCESS BOTTLENECK
Controlling Inflammation Is Key to Unlocking $10B+ Market Opportunity


Administration of CAR T and TCEs are limited to academic cancer centers. With these centers operating near capacity, 7 out of 10 eligible cancer patients do not have access these lifesaving treatments. By controlling the inflammation in the tumor microenvironment there is potential to improve efficacy and limit toxicity.

A near-term solution for
inflammation is urgently needed.

CTO1681 aims to offer a safe, effective, orally bioavailable, steroid-sparing therapy to prevent CRS and ICANs and mitigate inflammation in the TME. For healthcare providers, this means less hospitalization, fewer ICU admissions, and a greater capacity to treat more patients in need. For drug developers, this means more patients treated, wider adoption by the broader medical community, and more rapid advancement of CAR T and TCE clinical programs. For patients, this means increased accessibility, lower costs, and overall better outcomes from their cancer treatments.

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1. Gust et al. Cancer Discovery 2017
2. Strati P, Ahmed S, Furqan F, Fayad LE, Lee HJ, Iyer SP, et al. Prognostic impact of corticosteroids on efficacy of chimeric antigen receptor T-cell therapy in large B-cell lymphoma. Blood. 2021;137(23):3272–6
3. Health Care Resource Utilization and Total Costs of Care Among Patients…, Keating, Gu, Jun, McBride, Transplant and Cellular Therapy, Jul 2022
4. 80% cancer care providers indicate toxicity management as primary cause for non-adoption.