- Initial studies with COVID-19 corona virus aim to replicate prior successful preclinical experiments of LEAPS against H1N1pandemic flu in mice conducted with National Institutes for Allergies and Infectious Diseases (NIAID)
- Treatment targeted for patients who are at highest risk of dying from COVID-19 due to tissue damage from infection to the lungs
- Principal Investigator for the COVID-19 study Dr. Ted Ross is world renowned researcher and key opinion leader in infectious disease and vaccine development
Newswise — Vienna, VA, March 23, 2020 -- CEL-SCI Corporation (NYSE American: CVM) announced today it 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,” stated CEL-SCI CEO Geert Kersten.
The University of Georgia (UGA) Center for Vaccines and Immunology (CVI) brings together a diverse, world- renowned team of experts in the areas of infectious disease, veterinary medicine, ecology and public health. The university’s world-class biocontainment research resources are coupled with the expertise of CVI investigators who focus on translational studies to test and assess the efficacy of vaccines and immunotherapies in development by industry, governmental and academic institutions. 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 world renowned 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.
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. 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.”
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.
About LEAPS The Ligand Antigen Epitope Presentation System (LEAPS) platform technology has demonstrated in several animal models the ability to design antigen-specific immunotherapeutic peptides that preferentially direct the immune response to a cellular (e.g., T-cell), humoral (antibody) or mixed response and are also capable of enhancing important T-regulatory (Treg) responses. Therefore, the LEAPS technology provides the opportunity to develop immunotherapeutic products for diseases for which disease associated antigenic peptide(s) sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases (e.g., RA), allergic asthma and allergy, select CNS diseases (e.g., Alzheimer's) and the COVID-19 associated virus.
The Company's LEAPS technology is currently also being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by $1.5 million grant for IND enabling studies from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
About CEL-SCI Corporation CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with Multikine* first, BEFORE they received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
CEL-SCI's Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma are treated with the Multikine treatment regimen for 3 weeks prior to the Standard of Care (SOC) which involves surgery, chemotherapy and/or radiation. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby thought to better able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body's immune system prior to SOC. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups.
The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K/A for the year ended September 30, 2019. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.