CEL-SCI and NIAID Publish Data Showing That CEL-SCI's LEAPS Technology Halted Progression of Lethal Influenza in Three Different Influenza Virus Strains, Including a Drug-Resistant and a 2009 Pandemic Flu Strain

CEL-SCI Corporation

announces the publication of the results of influenza studies by researchers from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and CEL-SCI in the Journal of Clinical Investigation, a leading journal for discoveries in basic and clinical biomedical research (2013 J Clin Invest. doi: 10.1172/JCI67550 2013, supplemental information at www.jci.org/articles/view/67550). The studies described in the publication show that when CEL-SCI's investigational J-LEAPS Influenza Virus treatments were used “in vitro” to activate immune cells called dendritic cells (DCs), these activated dendritic cells, when injected into influenza infected mice, arrested the progression of lethal influenza virus infection in these mice. The work was performed in the laboratory of Kanta Subbarao, M.D., Chief of the Emerging Respiratory Diseases Section in NIAID's Division of Intramural Research. This work is particularly important because it involved influenza strains that are drug-resistant and because the protection is achieved by significantly reducing the number of inflammatory immune cells in the lungs, a significant contributor to death from certain influenza viruses. The investigators state in the article: “Our data demonstrate that Influenza-J-LEAPS-pulsed DCs reduce virus replication in the lungs, enhance survival, and modulate the protective immune responses that eliminate the virus while preventing excessive cytokines that could injure the host. This approach shows promise as an adjunct to antiviral treatment of influenza virus infections.” In a mouse model of influenza virus infection having an ongoing and established disease process, the administration of activated J-LEAPS-DCs for up to several days following the initiation of influenza virus infection prevented morbidity and mortality as evidenced by the measurement of several key disease associated parameters: (1) the mice did not lose weight, (2) virus production was significantly reduced in treated mice, and (3) in general, there was less inflammatory immune response present, as indicated by a decrease of the inflammatory immune responses in the lungs of infected mice treated with J-LEAPS-DCs, all as compared to controls. J-LEAPS-DC treatment of the infected mice also prevented the over production of inflammatory cytokines. The prevention of the over production of inflammatory cytokines, something also called “cytokine storm”, could also be very important clinically because the over production of inflammatory cytokines is often associated with a worsening of the clinical condition of these patients, which may lead to death. A new and separate NIAID study in mice shows that excessive early immune responses contribute to deaths caused by certain influenza viruses. Scientists found that reducing the number of inflammatory immune cells in the lungs of mice increased the animals' survival after infection with a virulent flu strain. The researchers, led by Marlène Brandes, M.D., Ph.D., and Ronald Germain, M.D., Ph.D., of NIAID's Laboratory of Systems Biology (LSB), reported their results in the July 3, 2013, issue of Cell. The J-LEAPS-DC appeared to be preferentially directed home to the infected lungs and rapidly activated antigen specific T cells capable of killing the virus infected cells. These activated specific T cells recognized the influenza-related peptide that was part of the J-LEAPS influenza virus treatment. Incorporation of other influenza peptides into LEAPS treatments did not elicit protection. This demonstrated the specificity of the J-LEAPS-DC response and the need when developing treatment to target and select specific Influenza virus peptides in order to be able to achieve the desired treatment outcome. The J-LEAPS-DCs also protected mice from disease when mice were infected with the pandemic 2009 strains and the pH1N1 Influenza virus strain that is oseltamivir (Tamiflu®) resistant. “These findings demonstrate the potential broad applicability of the LEAPS technology in the treatment of drug-resistant and other influenza strains. Since some of these strains have similarities with the newly described H7N9 Virus, this novel experimental approach for influenza treatment could possibly become useful in case of a future influenza pandemic,” said Dr. Daniel Zimmerman, Senior Vice President of Research, Immunology and the inventor of LEAPS. The LEAPS treatments in this study consisted of a disease epitope (portion of a disease associated antigen - a protein) attached to a portion of another very small protein immune cell binding ligand (ICBL) chosen to promote and direct the immune response. By themselves, neither the ICBL nor the disease epitope initiate protection, but when conjugated together, the LEAPS treatments promote immune responses that have been shown to protect against influenza virus infection. LEAPS-peptide treatments and LEAPS-based dendritic cell vaccines and treatments are thus thought to have the potential to provide protection and treatment for infectious diseases. In other studies, LEAPS treatments also have shown the ability to retard progression and alleviate symptoms of Rheumatoid Arthritis. About CEL-SCI Corporation CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating a treatment (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.