CEL-SCI Announces $1.5 Million NIH SBIR Grant To Support Development Of Rheumatoid Arthritis Vaccine
Published: Sep 19, 2017
Previous pre-clinical studies show CEL-SCI’s LEAPS technology prevented the development, lessened the severity of arthritis and described in part the mechanism of action and target cells
VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) announced today that it 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.”
About Rheumatoid Arthritis
Rheumatoid Arthritis is a chronic inflammatory disease that mainly targets the synovial membrane, cartilage and bone. It affects about 1% 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®).
About CEL-SCI Corporation
CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational immunotherapy, Multikine* (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. The study was designed with the objective that, if the study endpoint, which is an improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. The Company’s LEAPS technology is 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.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI’s filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K and 10-K/A for the year ended September 30, 2016. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Gavin de Windt, 703-506-9460