Collaboration initiated to develop COVID-19 immunotherapy

A collaboration between the University of Georgia’s (UGA’s) Center for Vaccines and Immunology, US, and CEL-SCI Corporation has been formed to develop a Ligand Antigen Epitope Presentation System (LEAPS) COVID-19 immunotherapy. The immunotherapy candidate aims to treat patients at highest risk of dying from the novel coronavirus. 

According to the new partners, the work will commence with pre-clinical studies based on experiments previously conducted with the LEAPS immunotherapy platform in collaboration with the US National Institutes for Allergies and Infectious Diseases (NIAID) against another respiratory virus, influenza A (H1N1). 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 prevent the progression of the viral infection and prevent tissue damage from inflammation resulting from lung infiltration by the virus. By stimulating the correct immune responses 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.

The studies will utilise the LEAPS peptide approach that elicits 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 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 antibodies were 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.

“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 honoured to partner with Dr Ted Ross and his team and the UGA Center for Vaccines and Immunology. Their world-renowned expertise and world-class facilities will accelerate the development of LEAPS COVID-19 immunotherapy,” stated CEL-SCI Chief Executive Officer Geert Kersten.

Dr Ross commented: “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. UGS’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.”