Benzinga | Dec 1, 2020 09:12AM EST

CEL-SCI Corporation Highlights Study Showing Its LEAPS COV-19 Peptides Achieved A 40% Survival Rate In Transgenic Mouse Models

LEAPS targets the non-mutating part of the SARS-CoV-2 virus and works through activating a T cell response possibly offering long term benefits

CEL-SCI Corporation (NYSE:CVM) announced today its LEAPS COV-19 peptides, delivered as a therapeutic treatment following SARS-CoV-2 virus challenge, achieved a 40% survival rate in transgenic mouse models as compared to 0% survival in the two control groups in studies conducted at the University of Georgia Center for Vaccines and Immunology.

Scientists at the University of Georgia working in conjunction with CEL-SCI's scientific team conducted a challenge study in human(h) ACE2 receptor transgenic mice infected with a dose of SARS-CoV-2 (the causative agent of COVID-19 disease) virus sufficient to cause death in all animals within 8 days. This transgenic animal model is useful to study COVID-19 disease because the mice express the molecule that provides entry for the SARS-CoV-2 virus into human cells. Virus infection is optimized in this animal model providing an ideal system to determine vaccine induced immune protection or therapy against a SARS-CoV-2 infection of humans.

The animals were therapeutically treated with CEL-SCI's LEAPS COV-19 peptides one day after infection with a lethal dose of SARS-CoV-2. Of the LEAPS treated mice, forty percent (40%) were alive, recovering and regained lost weight, attaining > 90% of their starting weight, by the study's end. In contrast, mice in the two control groups lost 20% or more of their body weight by day 8 and all of them died between day 5 and day 8 post challenge. The success of this therapy was statistically significant at a 95% level.

An additional study conducted using LEAPS as a vaccine to prevent disease resulted in similar findings to the above described study, but with a slightly lower level of statistical significance. In this study, the Human(h) ACE2 transgenic mice were dosed twice with the LEAPS conjugate 28 and 14 days prior to being challenged with a lethal dose of SARS-CoV-2 virus.

"We are highly encouraged by these results, which clearly show our LEAPS COV-19 peptides produced a survival benefit in a very credible animal model, which mimics the virus' effects in humans. A critical benefit of LEAPS's mechanism of action is its focus on highly conserved portions within the nucleoprotein of the virus. This may become very important as mutations in SARS-CoV-2 that could limit a vaccine or treatment induced protection have already been reported. While LEAPS can potentially work as a vaccine, the greater need though is to provide better treatment for the acute disease stage and also for the longer-term complications of the virus. Helping those patients is our goal," stated CEL-SCI CEO Geert Kersten.

Daniel Zimmerman, Ph.D., Senior VP of Research Cellular Immunology at CEL-SCI and discoverer of the LEAPS technology added, "Based on prior animal studies we also know that LEAPS peptides can reduce inflammation and cytokine storm. We think it is likely to have a similar effect on the cytokine storm that causes severe systemic COVID-19 disease. Our next step is to leverage the findings from these two animal studies into future studies that will optimize treatment dosing and test additional LEAPS peptides as a therapy."