Regulatory News:

NEOVACS (Alternext Paris : ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced that it has recruited all 140 patients necessary for its TNF-Kinoid phase IIb study in Rheumatoid Arthritis (RA).

“We are pleased to report that the completion of our trial enrollment was consistent with timing laid out in our development plan,” said Pierre Vandepapelière, M.D., Ph.D., Neovacs Chief Medical Officer. “The robust investigator and patient participation we have experienced in this trial underscores the significant unmet medical need in RA and the potential an innovative, natural and long-lasting therapeutic approach holds in the treatment of in this disease.”

Study design and evaluation criteria

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 Lebanon1. 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.

“Thanks to our research partners and team members, we were able to recruit the necessary number of patients in more than 40 international centers for our RA study under a tight timeframe. Our intention remains to publish study results before the end of the year, and we are confident these results will demonstrate the clinical efficacy of our anti-TNF Kinoid,” said Miguel Sieler, Neovacs Chief Executive Officer.

About Neovacs

Neovacs is a biotechnology company focused on an active immunotherapy technology platform (Kinoids) with applications in autoimmune and/or inflammatory diseases. On the basis of the company’s proprietary technology for inducing a polyclonal immune response (covered by six patent families that run until at least 2023) Neovacs is focusing its development efforts on two active immunotherapies: TNF-Kinoid is being developed for the treatment of TNF-mediated autoimmune diseases such as rheumatoid arthritis and Crohn’s disease, whereas IFNα-Kinoid is being developed for the indication of lupus. Neovacs is also conducting preclinical works on IFNα-Kinoid in certain chronic viral infections, VEGF-Kinoid in Age-related Macular Degeneration (AMD) and solid tumors, and IL-4-Kinoid for the treatment of allergies. The goal of the Kinoid approach is to enable patients to have access to safe treatments with efficacy that is sustained in these life-long diseases.

For more information on Neovacs, visit www.neovacs.fr

1 Belgium, Hungary, Czech Republic, Poland, Ukraine, Moldova, Russia, Georgia, Serbia, Macedonia, Lebanon.

2 The Disease Activity Score 28 (DAS 28) response criteria is a scale to measure disease improvement at 28 tender & swollen joint count. It has been defined by the European League against Rheumatism.

3 The ACR score is a scale to measure disease improvement, named after the American College for Rheumatology.