Company Overview
CEL-SCI Corporation is focused on finding the best way to activate the immune system to fight cancer, infectious and autoimmune diseases. We have a cancer immunotherapy drug in a Phase 3 clinical trial and a patented T-cell modulation platform technology (LEAPS) being utilized to develop antigen specific treatments in preclinical studies. The LEAPS technology is the focus of our exhibit in the Innovation Zone sponsored by the NIH. We believe LEAPS may have the ability to reprogram a faulty immune system back to a more normal immune system and rheumatoid arthritis is the first indication. CEL-SCI’s lead candidate, CEL-4000, is being developed under a $1.5 million grant from NIAMS of NIH for the treatment of rheumatoid arthritis. Upon completion of preclinical and IND enabling studies for CEL-4000, CEL-SCI intends to file an IND application with the FDA. CEL-SCI’s platform technology, referred to as LEAPS (Ligand Epitope Antigen Presentation System), has been shown to be effective (e.g., protective) in several animal models (for infectious diseases [HSV-I or Influenza A virus], oncology [Her2/Neu] and autoimmune [two different types of arthritis and autoimmune myocarditis]) to preferentially direct the immune response to a cellular (e.g., T-cell), humoral (antibody) or mixed pathway as best needed and has been shown to involve upregulation of T-regulatory (Treg) cells in some animal models. LEAPS 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). Multikine is our lead investigational immunotherapeutic agent in the final stages of a pivotal Phase 3 clinical trial. When it comes to cancer immunotherapy, CEL-SCI believes it is most logical to boost the patient's immune system while it is still intact. That should be the best time to activate an anti-tumor immune response. Therefore, CEL-SCI treats patients who are newly diagnosed with head and neck cancer with its lead investigational immunotherapy Multikine BEFORE they have received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are used only after conventional therapies have been tried and/or failed. Head and neck cancer represents about 6% of all cancers. The Phase 3 study was fully enrolled with 928 patients as of September 2016. The Company is waiting for 298 events to determine if Multikine confers a survival benefit. Multikine has received Orphan Drug designation from the FDA for the treatment of head and neck cancer patients with advanced squamous cell carcinoma. No LEAPS product or Multikine has been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. CEL-SCI has operations in Vienna, Virginia, and in/near Baltimore, Maryland.