CEL-SCI Corporation (CEL SCI), a biotechnology company, announced that its investigational LEAPS rheumatoid arthritis vaccine candidate has been accepted for a new programme of technology commercialisation and niche analysis managed by Foresight Science & Technology for the US National Institutes of Health (NIH).
CEL-SCI's selection into this commercialisation programme, including market entry strategy and launch tactics, is an extension of the phase I Small Business Innovation Research (SBIR) grant in the amount of $225,000 awarded to CEL-SCI in July 2014 from the NIH's National Institute of Arthritis Muscoskeletal and Skin Diseases (NIAMS).
Only a select number of SBIR recipients are additionally awarded the commercialisation and launch niche analysis programme, which will examine the market in depth for the LEAPS rheumatoid arthritis vaccine. This analysis will include interviews with experts and end-users, recommendations for a market entry, launch tactics and revenue projections. According to Visiongain, the world rheumatoid arthritis drug market will generate revenues of $38.5 billion in 2017.
"As we advance the clinical development programme for our LEAPS rheumatoid arthritis vaccine, we are very pleased that the NIH has recognized the potential market value of this product. We believe the commercialisation and programme niche analysis will be of value to CEL-SCI as we apply for a phase II SBIR grant to continue to support our efforts of bringing LEAPS into human clinical trials," stated Daniel Zimmerman, Ph.D., senior vice president research and development, Cellular Immunology.
LEAPS (Ligand Epitope Antigen Presentation System) is a CEL-SCI patented platform technology designed to stimulate antigen-specific immune responses in T-cells using synthetic peptides. LEAPS constructs physically link the antigenic peptide with a T-cell binding ligand and are delivered directly to the recipient immune system by injection or mucosal absorption, potentially enhancing T-cell responses to a particular antigen.
In pre-clinical work conducted by Tibor Glant, MD, Ph.D and his team at Rush University Medical Center in Chicago in collaboration with CEL-SCI, data showed that the administration of a proprietary peptide using CEL-SCI's LEAPS technology prevented the development, and lessened the severity, including inflammation, of experimental rheumatoid arthritis when it was administered after the disease was induced in animals. This data was presented in May 2013 by Dr. Zimmerman, at the symposium on "Therapeutic Approaches to Autoimmunity" during the American Association of Immunologists (AAI) 100th annual meeting.
Rheumatoid Arthritis is a chronic inflammatory disease that mainly targets the synovial membrane, cartilage and bone. It affects about 1 per cent of the global population and is associated with significant morbidity and increased mortality. Anti-TNF related therapies are the current standard treatment of patients with advanced RA, but over half of the RA patients do not respond to current anti-TNF drugs such as etanercept (Enbrel) and infliximab (Remicade).