CEL-SCI Corporation has been awarded a new phase II Small Business Innovation Research (SBIR) grant by the National Institute of Arthritis and Musculoskeletal and Skin Diseases entitled “Preclinical studies of PG70 LEAPS peptide vaccine for rheumatoid arthritis”.  The grant in the amount of approximately $1.5 million will provide funding to allow CEL-SCI to advance its first LEAPS product candidate, CEL-4000, towards an Investigational New Drug (IND) application, by funding GMP manufacturing, IND enabling studies, and additional mechanism of action studies.  

The work will be conducted at CEL-SCI’s research laboratory and Rush University Medical Center in Chicago, Illinois at the laboratories of Tibor Glant, MD, Ph.D., The Jorge O. Galante Professor of Orthopedic Surgery and Katalin Mikecz, MD, Ph.D. Professor of Orthopedic Surgery & Biochemistry.

The grant was awarded based on published data by Dr. Glant’s team in collaboration with CEL-SCI showing that the administration of a proprietary peptide using CEL-SCI's LEAPS technology prevented the development, and lessened the severity, including inflammation, of experimental proteoglycan induced arthritis (PGIA or GIA) when it was administered after the disease was induced in the animals.  This data was recently published in Vaccine in an article titled “An epitope-specific DerG-PG70 LEAPS vaccine modulates T cell responses and suppresses arthritis progression in two related murine models of rheumatoid arthritis” by Mikecz et al.

“These findings, in conjunction with the results from previously conducted studies with LEAPS vaccines in the PGIA and GIA and other autoimmune models suggest that LEAPS vaccines may be used as a therapeutic treatment in a variety of different types of autoimmune conditions.  LEAPS vaccines may be advantageous to other therapies because the LEAPS vaccines act early on the immune system and inhibit the production of disease-promoting inflammatory cytokines, unlike anti-Tumor necrosis factor alpha (TNFa) therapy which generally acts late and neutralizes only one individual inflammatory cytokine out of many involved in the disease process,” said CEL-SCI’s Senior Vice President of Research, Daniel Zimmerman, Ph.D.

Dr. Zimmerman continued, “The successful conclusion of this round of studies in this autoimmune disease takes LEAPS closer to human studies and could open its development to various other autoimmune diseases, such as multiple sclerosis, uveitis, colitis (inflammatory bowel disease) and certain types of diabetes.”