CytoAgents

About CytoAgents

CytoAgents is a Pittsburgh-based, clinical-stage biotechnology company established in 2018, operating in the substantial and growing Cytokine Release Syndrome (CRS) treatment market. The company is focused on developing pharmaceutical products to treat life-threatening symptoms associated with CRS, also known as "cytokine storm," which is a severe overreaction of the immune system. This condition can be triggered by various factors, including advanced cancer immunotherapies like CAR T-cell therapy, as well as viral infections.

The company was founded under the leadership of CEO Teresa Whalen, a registered pharmacist with over two decades of experience in the healthcare sector, spanning roles as a biotech innovator, healthcare technology leader, and life sciences investor. Her extensive background includes a successful track record of bringing new healthcare products to market and executive positions at major corporations like Siemens Medical and Baxter International, providing her with a robust foundation for steering CytoAgents through its clinical and financial milestones. Whalen was also recognized as an Entrepreneur Of The Year® 2023 East Central Award finalist, a testament to the company's progress.

CytoAgents' core business revolves around its lead drug candidate, GP1681 (also referred to as CTO1681), an orally administered small molecule designed to modulate the body's immune response. Unlike existing treatments that may cause broad immunosuppression, GP1681 employs a host-directed approach. It targets the NF-kB and PGE2 signaling pathways to downregulate the production of a wide range of inflammatory cytokines, thereby calming the immune system while leaving its essential functions intact. This positions GP1681 as a potential therapy to not only treat CRS but also to be used preventatively in patients undergoing treatments known to cause this adverse effect. The company's revenue model will be based on the successful commercialization and sale of its pharmaceutical products upon regulatory approval.

The company has achieved significant milestones, including securing approximately $38.6M in funding through a combination of venture capital and non-dilutive grants from institutions like the National Institutes of Health (NIH) and the Richard King Mellon Foundation. CytoAgents has successfully completed a Phase 1a human clinical trial, which demonstrated a strong safety profile for GP1681. In May 2023, the FDA approved its Investigational New Drug (IND) application to begin a Phase 1b/2a clinical trial for lymphoma patients receiving CAR T-cell therapy. The first cohort of this trial was successfully completed, allowing the study to advance to a higher dose, marking progress in developing a treatment for this critical unmet need.