CEL-SCI's Scientific Article on Vaccines for Autoimmune Disease Published in Journal of Clinical & Cellular Immunology

Business Wire 4-Mar-2019 8:00 AM

• LEAPS therapeutic vaccine platform holds potential for early treatment of autoimmune diseases including rheumatoid arthritis, multiple sclerosis and type 1 diabetes
• U.S. NIH currently researching LEAPS as therapeutic vaccine for rheumatoid arthritis under $1.5 M grant

CEL-SCI Corporation (NYSE:CVM) today announced the Journal of Clinical & Cellular Immunology has published an article titled, "Why Don't We Have a Vaccine Against Autoimmune Diseases?" co-written by Dr. Ken Rosenthal of Roseman University College of Medicine, and CEL-SCI's Roy Carambula, Research Associate and Daniel Zimmerman Ph.D., Senior Vice President of Cellular Immunology.

As presented in the article, vaccines that are widely used today for infectious diseases are considered preventative and are usually directly tied to eliciting a specific antibody response in patients. Alternatively, vaccines for autoimmune diseases need to be therapeutic and focused on cellular immunity, not antibodies. As discussed in this review in some detail, developing a therapeutic vaccine is more challenging because autoimmune diseases manifest differently in each patient, driven by various triggering antigens and antibody and cellular or inflammatory immune responses. While challenging to develop, effective therapeutic vaccines for autoimmune disease would be of tremendous value.

A report issued by the Institute of Medicine titled, "Vaccines for the 21st century" challenged the scientific community nearly two decades ago to develop vaccines for a specific list of indications that would lead to the greatest health and economic benefits. Of the top seven vaccine targets identified by the Institute of Medicine, three are autoimmune diseases, rheumatoid arthritis (RA), multiple sclerosis (MS), and type 1 diabetes (T1D).

"The Institute of Medicine identified a clear need for the wider use of vaccines and challenged the scientific community to deliver. CEL-SCI's LEAPS platform has the potential to meet this challenge based on the vaccine's ability to define and direct the nature of an antigen-specific immune response, thus creating a personalized therapy for autoimmune disease. An off-the-shelf therapeutic LEAPS vaccine may provide the personalized medicine necessary to treat autoimmune diseases at their earliest stage, thus forestalling or preventing disease progression," CEL-SCI's Dr. Zimmerman stated.

The LEAPS platform technology is currently being utilized to develop a therapeutic vaccine for rheumatoid arthritis (RA) under a $1.5 million grant from the U.S. National Institutes of Health (NIH). Upon completion of preclinical and Investigational New Drug (IND) enabling studies for the LEAPS-based rheumatoid arthritis vaccine candidate CEL-4000, CEL-SCI intends to file an IND application with the U.S. Food and Drug Administration.

About LEAPS

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 T-regulatory (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's LEAPS technology is currently being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health. 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 for the year ended September 30, 2018. 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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