CEL-SCI Corporation (NYSE American: CVM) announces that it has concluded animal experiments using its LEAPS COVID 19 conjugate that provide the basis for moving forward into animal challenge studies with live virus SARS-CoV-2, the causative agent of COVID 19, at the University of Georgia Vaccine Center. These SARS-CoV-2 challenge studies seek to repeat the success of animal challenge studies conducted previously at the NIH/NIAID emerging diseases laboratory during the threatened H1N1 flu pandemic.
The LEAPS COVID 19 conjugate has been designed employing the same concepts as were used to construct the LEAPS H1N1 conjugate which was successfully employed in previous H1N1 pandemic flu studies. In those prior studies reduced morbidity and mortality were observed in H1N1 virus infected animals treated with the LEAPS H1N1 construct. The LEAPS H1N1 conjugates were administered after virus challenge as a therapeutic intervention. We believe these results and the positive results achieved in studies with LEAPS constructs in other diseases are strongly suggestive that the LEAPS COVID 19 challenge studies at the University of Georgia Vaccine Center may also be successful.
The recent animal experiments showed that LEAPS COVID 19 conjugates induced faster and much higher than expected antibody responses against a non-mutating region of the virus that causes COVID 19, after only one injection. It is important to note that IgG antibodies response was generated within 10 days of a single immunization. Generation of IgG requires activation of dendritic, T and B cells in order to promote the class switch from IgM to IgG antibody.
Daniel Zimmerman, Ph.D., Senior VP of Research Cellular Immunology at CEL-SCI and discoverer of the LEAPS technology said; "We now have the immunogenicity data showing that the LEAPS technology may work against COVID 19. Similar results were obtained with LEAPS-H1N1 conjugates, in animals that were infected with H1N1 virus and subsequently treated with LEAPS-H1N1 conjugates. Those challenge studies resulted in a decrease in morbidity and mortality against pandemic flu H1N1 in a mouse model study conducted at the NIAID. These studies give us confidence that the challenge studies we are now undertaking with live virus SARS-CoV-2 in an animal model of COVID 19 at the University of Georgia Vaccine Center will be successful."
Background on LEAPS and its Relevance to COVID 19:
CEL-SCI's goal is to develop an immunotherapy with the potential to treat the COVID 19 coronavirus using its patented LEAPS peptide technology. The LEAPS peptides utilize conserved regions of coronavirus proteins to stimulate protective antibody and cell mediated T cell responses and reduce viral load. The LEAPS peptide technology can be used to construct immunotherapeutic peptides that exhibit both antiviral and anti-inflammatory properties at the same time. Consequently, these products not only target the virus infection against which they are directed, but also elicit the appropriate protective response(s) against it, without exacerbating an overly active inflammation.
CEL-SCI's studies are utilizing the LEAPS peptide approach which 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 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 LEAPS-COVID-19 peptide conjugates are directed towards antigens within the NP protein of SARS-Cov-2 the causative agent of COVID-19 that elicit cytolytic T cell responses to virus infected cells. Unlike glycoprotein spike antigens which are important for antibody-based vaccines, these 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.
Ligand Epitope Antigen 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 virus SARS-Cov-2, the causative agent of COVID-19.
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 its global pivotal 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.
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, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. 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. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical trials or nonclinical 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.
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