17 May 2019 - - US-based CEL-SCI Corp.'s (NYSE American: CVM) senior vice president of research, cellular immunology Daniel Zimmerman, Ph.D. has presented new LEAPS data at the American Association of Immunologists 103th annual meeting (Immunology 2019) in San Diego, California on May 11, the company said.

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 called recombinant PG G1 domain-induced arthritis, an autoimmune mouse model of rheumatoid arthritis.

The LEAPS platform technology is currently being utilised to develop a therapeutic antigen-specific treatment for RA under a USD 1.5m grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health.

Upon completion of preclinical and Investigational New Drug enabling studies for the antigen-specific LEAPS vaccine treatment of RA, 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 protective Treg cells in some animal models.

It has the potential to be utilised 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 has operations in Vienna, Virginia, and in/near Baltimore, Maryland.