Achieving Long-Term Treatment for Severe Autoimmune Diseases with Neovacs’ Kinoid Polyclonal Antibody Active Immunotherapy Print E-mail
By Guy-Charles Fanneau de La Horie, CEO of Neovacs S.A.   
Tuesday, 01 March 2011 03:11
Expert BriefingMonoclonal antibodies (mAbs) revolutionized autoimmune disease treatment and are the most commercially successful biologic drugs but they often lose efficacy over time.  The leading tumor necrosis factor (TNF) alpha inhibitors – Remicade, Humira and Cimzia – for autoimmune diseases including rheumatoid arthritis (RA) and Crohn’s Disease have major limitations.
 

Neovacs S.A., Paris

NEOVACS (ENX: ALNEV)

It is projected that by 2012 the number of RA patients having failed a TNF inhibitor (696,000) will exceed the number taking their first biologic drug (643,000). Data from controlled clinical trials also shows in Crohn’s Disease that there is more than a 50 percent drug failure rate for each of the three approved mAbs after their first year regardless of whether they are based on fully human or mouse/human chimeric structures. This is due in part to the patients’ immune system reacting to the mAb as a foreign entity and raising an immune response against it.  In addition, monoclonal antibodies recognize and bind to a single site (epitope) on the target.  If the epitope is absent or shielded, the mAb will become ineffective.

As a result, there remain significant unmet medical needs in these autoimmune diseases, which affect millions of Americans and tens of millions of people worldwide.  To address these challenges, French biotechnology company Neovacs S.A. (Alternext Paris: ALNEV) has developed a novel active immunotherapy platform, the Kinoid, that uses the body’s own immune system to produce polyclonal antibodies to suppress disease-causing cytokine over-production.   As well as the potential advantages of broader and longer-lasting efficacy, Neovacs Kinoid therapy provides a more convenient dosing regimen than mAbs, with only 3 – 4 injections per year, at potentially much lower cost than mAbs, which typically cost $15,000 to $20,000 per patient each year. 

In a Phase I/II clinical trial of TNF- Kinoid in patients with Crohn’s Disease, Neovacs found the active immunotherapy had an excellent safety profile in all subjects and induced the production of anti-TNF (tumor necrosis factor) antibodies in 80 percent of patients. 

The Crohn’s disease trial patients also had a high sustained clinical response rate at 20 weeks, i.e. 4 months after the last injection with 72% showing clinical improvement and nearly half (44%) in clinical remission.  An analysis of calprotectin, a biomarker for intestinal inflammation, showed a normal calprotectin level in 7 of 10 patients at 12 weeks, a sharp decline over baseline, indicating reduced inflammation of the intestinal mucosa. Further, mucosal healing was observed in 6 patients out of 9 who received endoscopies.

Neovacs is now conducting two Phase II clinical trials in Europe, one in rheumatoid arthritis patients who have failed at least one TNF inhibitor, and the second in Crohn’s patients, also having failed a TNF inhibitor.
To address the limitations of current monoclonal antibody therapies for severe autoimmune diseases, Neovacs is developing Kinoid polyclonal antibody active immunotherapy to safely, affordably and effectively provide long-term treatment for rheumatoid arthritis and Crohn’s disease with TNF-Kinoid and IFNα-Kinoid for lupus.


Author Guy-Charles Fanneau de La Horie is the Chief Executive Officer of Neovacs S.A. in Paris, France.
He contributed this expert briefing for our readers.



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