Clinical Trials

Date: 2014-04-07

Type of information: Initiation of preclinical development

phase: 2b

Announcement: completion of patient enrollment

Company: Neovacs (France)

Product: TNF-Kinoid

Action mechanism:

kinoid/immunotherapy product. A Kinoid is obtained by chemically linking the cytokine of interest to a foreign carrier protein, KLH ( Keyhole Limpet Hemocyanin), and then treating the resultant compound to inactivate the cytokine. These active immunotherapies have been designed to induce an antibody response by the patient’s immune system that targets a particular over-expressed cytokine responsible for the pathogenesis and development of a given disease. The Kinoid technology can be applied in principle to any cytokine target. Three targets (Tumor Necrosis Factor (TNF), Interferon alpha (IFN alpha) and Vascular Endothelial Growth Factor (VEGF) are considered as playing a key role in the pathogenesis of certain diseases.


rheumatoid arthritis

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Country: Belgium, Moldova, Georgia, Hungary, Czech Republic, Poland, Lebanon

Trial details:

The international, double-blind, randomized, placebo-controlled TNF-K-006 study will recruit 140 patients with active disease despite methotrexate. The primary endpoint for the study is clinical efficacy. Results are expected Q4 2014.

Latest news:

* On April 7, 2014, Neovacs has announced that it has recruited all 140 patients necessary for its TNF-Kinoid phase IIb study in rheumatoid arthritis. The phase IIb study of TNF-Kinoid in RA recruited 140 patients naïve to anti-TNF treatments. Inpatients were recruited from 11 countries throughout Western and Central Europe and Lebanon. The primary  endpoint of the study was clinical efficacy as measured by DAS 282 and ACR3 criteria. Complete study results are expected in Q4 2014.
* On March 11, 2014, Neovacs has announced that the independent Data and Safety Monitoring Board (iDSMB) reviewing the safety data of the phase IIb clinical trial of TNF-Kinoid in rheumatoid arthritis issued a positive assessement of the study. Following its evaluation of the safety data on nearly half of the patients forseen in the study, the committee issued a final report on March 11, 2014 with unrestricted approval based on the good safety profile of the Kinoid at the actual stage of the study.All study study centers (about 40) are operational. Recruitment is on track with study results expected Q4 2014.

* On December 6, 2013, Neovacs has announced that it has successfully enrolled the first patients in the Phase IIb study of TNF-Kinoid for the treatment of rheumatoid arthritis (RA). These patients have received a first injection of the Kinoid. The TNF-Kinoid’s development plan is in line with the schedule announced by the Company at the time of its capital increase in March 2013. Proceeds from the capital increase are financing the study. Neovacs has received consents from the regulatory authorities and ethics committees in Belgium, Moldova, Georgia, Hungary, Czech Republic, Poland and Lebanon. Over 15 study centers are now operational, and dozens of patients have been screened for enrollement. Further approvals will be obtained soon in the other countries of the study. Results of a phase IIa study of TNF-Kinoid in RA have been published  in early 2012. The study had demonstrated the excellent safety profile of the Kinoid and had shown encouraging efficacy results in patients who had developed anti-TNF antibodies after injection with the Kinoid.

Is general: Yes