VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) announced today that Daniel Zimmerman, Ph.D., its Senior Vice President of Research, Cellular Immunology, presented new LEAPS data at the American Association of Immunologists 103th Annual Meeting (Immunology 2019) in San Diego, California on Saturday, May 11, 2019. The title of his presentation is “Therapeutic vaccination by two DerG LEAPS conjugates incorporating different PG (aggrecan) epitopes protect by different immune mechanisms in the PG G1 domain induced mouse model of rheumatoid arthritis”.
The work was performed in conjunction with researchers at Rush University Medical Center, Chicago, Illinois. CEL-4000 and a newly discovered LEAPS conjugate, DerG-PG275Cit, were evaluated alone and in combination in the sister model of proteoglycan [PG] induced arthritis (PGIA) called recombinant PG G1 domain-induced arthritis (GIA), an autoimmune mouse model of rheumatoid arthritis (RA).
Dr. Zimmerman commented, "Both CEL-4000 (DerG-PG70) and DerG-PG275Cit LEAPS vaccines are therapeutic in the GIA model of RA with high efficacy, although it appears that they act by different T helper 2/regulatory T cell (Th2/Treg)-associated protective mechanisms. In addition, these vaccines incorporate distinct epitopes that are located in distant regions of the PG molecule involved in arthritis induction. Thus, a combination vaccine containing both LEAPS conjugates CEL-4000 (DerG-PG70) and DerG-PG275Cit, could offer advantages, in case one epitope or another was missing in the disease inducing situation."
The LEAPS platform technology is currently being utilized to develop a therapeutic antigen-specific treatment for RA under a $1.5 million grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health (NIH). Upon completion of preclinical and Investigational New Drug (IND) enabling studies for the antigen-specific LEAPS vaccine treatment of RA, CEL-SCI intends to file an IND application with the U.S. Food and Drug Administration.
This platform technology has been shown in several animal models to preferentially direct the immune response to a cellular (e.g. T-cell), humoral (antibody) or mixed pathway, and has been shown to involve upregulation of protective Treg cells in some animal models. It has the potential to be utilized in diseases for which antigenic epitope sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases (e.g., RA), allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer's).
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 treats patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with Multikine first, BEFORE they receive 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 the 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 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 Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
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* 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.