CEL-SCI has signed a collaboration agreement with the University of Georgia’s Center for Vaccines and Immunology to develop LEAPS COVID-19 immunotherapy. CEL-SCI’s immunotherapy candidate aims to treat patients at highest risk of dying from COVID-19. The collaboration will commence with pre-clinical studies based on the experiments previously conducted with LEAPS immunotherapy in collaboration with the National Institutes for Allergies and Infectious Diseases (NIAID) against another respiratory virus, H1N1, involved in the 2009 H1N1 flu pandemic. Those successful studies demonstrated that LEAPS peptides, given after virus infection has occurred, reduced morbidity and mortality in mice infected with H1N1.

It is suggested, based on studies with H1N1, that a LEAPS coronavirus - SARS-CoV-2 immunotherapy may reduce or arrest the progression of the SARS-CoV-2 virus infection and prevent tissue damage from inflammation resulting from lung infection by the virus. By stimulating the correct immune responses to the COVID-19-causing virus without producing unwanted inflammatory responses associated with lung tissue damage, LEAPS immunotherapy may be particularly beneficial in those patients who are at highest risk of dying from COVID-19.

"We are eager to commence these studies, which if successful, may lead to clinical trials in humans to address the immediate and critical need to treat COVID-19 in the most vulnerable patients. We are very pleased and honored to partner with Dr. Ted M. Ross and his team and the University of Georgia Center for Vaccines and Immunology. Their world-renowned expertise and world-class facilities will accelerate the development of LEAPS COVID-19 immunotherapy," said CEL-SCI CEO Geert Kersten.

CEL-SCI’s COVID-19 studies at UGA will be led by Principal Investigator Ted M. Ross, PhD, Director of the Center for Vaccines and Immunology, Georgia Research Alliance Eminent Scholar, and Professor of Infectious Diseases at the University of Georgia. Dr. Ross is a key opinion leader in new vaccine technologies intended to protect against all strains for influenza and life-threatening viruses. Dr. Ross has published more than 160 papers and book chapters on infectious disease and vaccine development. He has been an invited speaker at more than 130 national and international conferences, and he participates in several vaccine working groups, including at the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention and the World Health Organization.

"LEAPS has the potential to be a powerful tool against SARS-CoV-2, the causative agent of COVID-19, based on its dual anti-viral and anti-inflammatory properties. Combining the prior pre-clinical data of LEAPS against H1N1 with our advancing knowledge of COVID-19, we aim to rapidly evaluate this technology’s potential to meet the urgent need to treat patients at greatest risk of dying from this global pandemic. The University of Georgia’s biocontainment labs at the Center for Vaccines and Immunology are ideally suited for these studies, and will serve as critical assets in this collaboration with CEL-SCI," Dr. Ross said.

CEL-SCI’s studies will utilize the LEAPS peptide approach that is unique in its proven ability in animals to elicit both a cell mediated antiviral response and an anti-inflammatory immunomodulating response by activating CD8 T lymphocytes. Previous studies showed that LEAPS immunogens can prevent lethal infection by herpes simplex virus (HSV) and influenza A (H1N1) and stop the inflammatory disease progression of rheumatoid arthritis in animal models. LEAPS peptides against HSV demonstrated that the T cell response was sufficient to prevent viral disease, and if there was residual virus production, anti-viral antibody was generated to further control the spread of the virus.

The proposed LEAPS peptides for the COVID-19 study are directed towards antigens within the NP protein of SARS-Cov-2 virus that elicit cytolytic T cell responses. Unlike the viral glycoprotein "spike" antigens which are important for antibody-based vaccines, these NP-antigens are less variable between viral strains and less likely to change in response to antibodies elicited by prior infection or other vaccines. Cytolytic T cell responses attack the virus infected cellular "factories" within the infected host in order to eliminate the source of virus and help subdue the infection.

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