5 March 2019 - - The Journal of Clinical and 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 US-based CEL-SCI Corp.'s (NYSE American: CVM) Roy Carambula, Research Associate and Daniel Zimmerman Ph.D., senior vice president of Cellular Immunology, the company said.

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, multiple sclerosis, and type 1 diabetes.

The LEAPS platform technology is currently being utilised to develop a therapeutic vaccine for rheumatoid arthritis under a USD1.5 m grant from the US National Institutes of Health.

Upon completion of preclinical and Investigational New Drug enabling studies for the LEAPS-based rheumatoid arthritis vaccine candidate CEL-4000, CEL-SCI intends to file an IND application with the US 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 T-regulatory 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).

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 three weeks prior to the Standard of Care 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.