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Neovacs Presents Successful Results of Crohn's Disease Drug Trial at European Crohn's & Colitis Congress

Towards a new therapeutic approach for Crohn’s Disease: Phase I/II results demonstrate the potential for the TNF-Kinoid in this inflammatory bowel disease

Neovacs presents the results of the TNF-K-001 clinical study at the European Crohn’s and Colitis Organization (ECCO) Congress which clearly demonstrate the significant promise in terms of both safety and clinical activity of the TNF-Kinoid in Crohn’s Disease.

Paris, France February 25, 2011 - Considering the major patient need for alternative therapies for this disease, Neovacs, a biotechnology company, has focused on developing a new approach based on a novel concept: active immunization to cytokine targets. Based on this platform, the TNF-Kinoid is in Phase II clinical development and is ultimately intended to treat patients suffering from moderate to severe Crohn’s Disease who have failed treatment with a TNF-inhibiting monoclonal antibody.

The final results of the Phase I/II study show the excellent safety profile of the TNF-Kinoid

The study was conducted in 21 patients with moderate to severe Crohn’s Disease (CDAI: 220-400). The study was an open-label, dose-escalation design, run at multiple clinical centers. The principal objectives were to evaluate the safety of the TNF-Kinoid and its ability to induce an immune response to TNF. Data was also collected allowing the calculation of each patient’s Crohn’s Disease Activity Index (CDAI), a composite score of disease attributes used to track disease severity. Three different dose levels were administered on Days 0, 7 and 28: 60 mg (n=3), 180 mg (n=9) or 360 mg (n=9). Four patients received a maintenance dose at 6 months.

After at least five months of follow-up, no severe adverse event related to the TNF-Kinoid has been reported, nor has any unusual infection been observed. All patients completed the study according to the protocol.

Clear induction of an immune response to TNF 17 of the 21 patients treated showed the production of antibodies directed to TNF. Of the 21 subjects, only one of the three that received the lowest dose (60 mg) responded. At the higher doses, 180 and 360 mg, 89% of patients produced antibodies to TNF. These results led to the conclusion that the 60 mg dose should not be included for evaluation in the Phase II program.

One patient in two in clinical remission one month after dosing At week 8, one month after the administration of the last dose of the Kinoid, 70% of patients in the study showed a clinical response, defined as a decline in CDAI of 70 points or more, and half were in clinical remission (a CDAI score of 150 or less). These results were sustained until at least week 20, four months after the last dose, with 72% of patients showing a response and 44% in remission. Clinical remission is recognized as the most important measure against which to evaluate new therapies for Crohn’s.

The presence of antibody at Week 8 is associated with remission at week 12 Patients with antibody to TNF at week 8 (14 out of the 21 in the study) had a more than 50% chance of being in clinical remission at Week 12. By contrast, patients without antibody at week 8 (7 out of 21) had a low probability (14%) of being in clinical remission at Week 12.

“These results are very encouraging.” commented Guy-Charles Fanneau De La Horie, Neovacs’ CEO “ They tend to suggest that the presence at Week 8 of antibodies induced by active immunization with the Kinoid are predictive of a good clinical response, exemplified by a high probability of achieving clinical remission at week 12, 2 months after the last dose. These data therefore speak to a potential clinical benefit that is both potent and durable.”

A reduction in intestinal inflammation and evidence of mucosal healing During the study, the evolution of calprotectin in the stools was also followed in ten patients. Calprotectin is a marker for intestinal inflammation. The results showed a normal calprotecti level in 7 of the ten patients at week 12, a sharp decline over baseline in most cases, indicative of a substantial reduction in inflammation of the intestinal mucosa. Further, colonoscopies undertaken in 9 patients showed mucosal healing in 6 of them.

In conclusion, noted Guy-Charles Fanneau De La Horie, “Taken together, these results lead one to think that antibodies generated by immunization with the TNF-Kinoid have strong clinical activity” He added that “This is the first time results like this have been seen using an active immunization approach to Crohn’s with TNF as the target. The Phase II study we recently began is designed to provide statistically significant confirmation of these first clinical results from the TNF-K-001 trial.”

About Neovacs Neovacs is a biotechnology company focused on an active immunotherapy technology platform (Kinoids™) with applications in autoimmune diseases and other chronic conditions. Neovacs' current portfolio consists of 3 drug candidates: TNF-Kinoid, IFNα-Kinoid and VEGF-Kinoid. The company’s lead immunotherapy program (TNF-Kinoid) targets TNF-mediated chronic inflammatory diseases. For TNF-Kinoid, a Phase I/II clinical trial in Crohn’s disease and a Phase II trial in rheumatoid arthritis (RA) are ongoing. The latter clinical study is also the focus of collaboration with the French diagnostics company BMD, with the goal of developing theranostic tools for personalized care in RA. Patient recruitment is ongoing in a Phase I/II trial of Neovacs’ second product candidate (IFNα -Kinoid, an immunotherapy targeting interferon alpha) in the treatment of lupus. Neovacs’ R&D has generated a broad patent estate.

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Disclaimer This press release and the information contained herein do not constitute an offer to sell or subscribe to, or a solicitation of an offer to buy or subscribe to, shares in Neovacs ("the Company") in any country. This press release contains forward-looking statements that relate to the Company’s objectives. Such forward-looking statements are based solely on the current expectations and assumptions of the Company’s management and involve risk and uncertainties. Potential risks and uncertainties include, without limitation, whether the Company will be successful in implementing its strategies, whether there will be continued growth in the relevant market and demand for the Company’s products, new products or technological developments introduced by competitors, and risks associated with managing growth. Unfavorable developments in connection with these and other risks and uncertainties described, in particular, in the Company’s prospectus prepared in connection with its IPO and on which the French Autorite des marches financiers (“AMF”) granted its visa no. 10-085 on April 8, 2010, could cause the Company to fail to achieve the objectives expressed by the forward-looking statements above.


Posted: February 2011