PITTSBURGH–(BUSINESS WIRE)–CytoAgents, a 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), announced today that it has been awarded a $2 million National Institutes of Health (NIH) grant, the second NIH grant in a year. The funding will accelerate the development of its lead drug candidate, GP1681, an investigational new drug that targets hypercytokinemia, more commonly known as “cytokine storm.”

Scientific consensus is building that overwhelming inflammation and severe illness is triggered by a phenomenon known as cytokine storm, a severe form of cytokine release syndrome when an excessive immune response attacks the body. There are many causes of cytokine storm and the CytoAgents mission is to develop a broadly accessible treatment for multiple indications of high unmet need of cytokine storm, including for Cytokine Release Syndrome (CRS) in CAR T-cell therapy and in COVID-19 patients. GP1681 uses a novel approach by calming the natural immune response addressing the underlying cause of life-threatening symptoms associated with cytokine storm.

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 trials for CAR T-cell therapy CRS and Phase 2 clinical trials for COVID are slated to begin by mid-2021.

“We thank the NIH for these awards, which, accompanied by our exceptional grant scores, are a tremendous validation of our science and the enormous potential of GP1681 to treat SARS-CoV-2, as well as to serve as the foundation for a broad pipeline of indications causing Cytokine Release Syndrome or cytokine storm with high unmet needs,” said Teresa Whalen, RPh, CEO, CytoAgents.

The Phase II SBIR grant of $2 million is non-dilutive funding from the National Institute of Allergy and Infectious Diseases of the NIH, under Award Number 1R44AI157719-01, and 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.

About CytoAgents

CytoAgents is a 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 also known as cytokine storm. There are many causes of CRS and our mission is to develop a broadly accessible treatment for multiple indications of high unmet need, including oncology CAR T-cell therapy, COVID-19, and respiratory epidemics. Using a novel approach by calming the natural immune response to a multi-organ disease, CytoAgents’ lead drug candidate, GP1681, is positioned to become the new best practice in medicine.