Immunovaccine Inc. announced positive results of a preclinical study testing the efficacy of combining CEL-2000, CEL-SCI Corporation’s rheumatoid arthritis (RA) vaccine antigen, and DepoVax, Immunovaccine’s vaccine enhancement and delivery platform.  The study results showed the “CEL-2000-DepoVax” combination considerably lessened the symptoms and slowed the progression of RA in the animal model with a single dose. The two companies will continue their research efforts to further optimize the CEL-2000-DepoVax vaccine combination for possible testing in future phase I clinical trials.

According to the National Institutes of Health (NIH), RA is a form of arthritis that causes pain, swelling, stiffness and loss of function in the joints. The disease affects approximately 2.1 million Americans and two to three times more women than men. CEL-2000 has the potential to slow the progression of rheumatoid arthritis. The DepoVax vaccine delivery technology is amenable to manufacturing and scale up in a GMP setting, providing the potential for quicker clinical development.

“We are extremely pleased that CEL-2000, when delivered in our platform, proved efficacious with as little as one dose,” said Dr Marc Mansour, Immunovaccine’s vice president of research and development. “These results provide further validation of the broad potential of our DepoVax vaccine delivery technology.”  

The study demonstrated that the CEL-2000 formulated in DepoVax vaccine effectively slowed the progression of RA and induced a statistically significant reduction in Arthritic Index (AI) score compared to the untreated control group. An RA vaccine that provides broad protection against rheumatoid arthritis is expected to be better received than current therapies that address the symptoms associated with RA.

The results of this research collaboration were presented today at the annual GTCBio conference in Washington, D.C.

CEL-SCI Corporation’s rheumatoid arthritis vaccine, CEL-2000, was discovered as part of work with the Company’s ongoing research and development activities with its patented L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology.  L.E.A.P.S. is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize proprietary immunogens.

CEL-2000 is able to block the inflammatory process earlier and in an antigen-specific manner. Studies have shown that CEL-2000 inhibits the tumour necrosis factor alpha (TNF-alpha). The TNF-alpha is an important therapeutic target because it is a pro-inflammatory cytokine or regulatory protein found in abundance in RA tissue. By targeting the TNF-alpha there is a significant reduction in inflammatory activity.

CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine. In Phase II clinical trials Multikine was shown to be safe and well tolerated, and to improve the patients' overall survival by 33 per cent at a median of three and a half years following surgery.

Immunovaccine’s DepoVax platform is a lipid depot-based vaccine delivery and enhancement technology. This patented combination is a breakthrough in vaccine development because it raises unusually strong and long-lasting cellular or humoural immune responses that allow a reduction in the number of doses required for efficacy and earlier onset of protection.

Immunovaccine Inc. is a clinical stage vaccine development company focused on the commercialization of its patented DepoVax vaccine delivery technology and product candidates.  The company continues to strengthen its vaccine pipeline through licensing and strategic partnerships to develop therapeutic cancer and infectious disease vaccines.