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Neovacs Confirms Potent and Long-Lasting Biological Activity of IFNa-Kinoid 4 Years After Patient Dosing in Phase I/IIa Trial

Company Presented Extended Follow-Up Data on IFNα-Kinoid at 11th International Congress on Lupus

PARIS and BOSTON, Sept. 9, 2015 (GLOBE NEWSWIRE) -- NEOVACS (Alternext Paris:ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced that it presented extended follow-up data from the Phase I/IIa clinical trial of IFNα-Kinoid during Lupus 2015, the 11th International Congress on Systemic Lupus Erythematosus (SLE), which took place from 2 to 6 September 2015 in Vienna, Austria.

"The results we presented at Lupus 2015 show that our lead product candidate induces a lasting, polyclonal, neutralizing anti-IFNα response in SLE patients. This is an extremely positive sign as we are about to launch the Phase IIb trial of IFNα-Kinoid in SLE," commented Thérèse Croughs, M.D., Chief Medical Officer of Neovacs.

This new data1, collected as part of the Phase I/IIa extended follow-up study of six IFNα-Kinoid-treated patients, demonstrates that anti-IFNα neutralizing antibodies generated by IFNα-Kinoid continue to be present four years after the first immunization, and maintain the normalization of the IFNα signature. This confirms previously reported results2.

The study also highlights the association between anti-IFNα neutralizing antibodies and the decreased expression of induced genes associated with B cell activation. B-cell activation, like the IFNα-signature, has been linked to the pathogenesis of SLE lupus.3

Follow up data from the Phase I/IIa clinical trial was presented in the poster "IFNα-kinoid (IFN-K) induces neutralizing anti-IFNα antibodies that decrease the expression of IFN-induced and B cell activation associated transcripts : Analysis of extended follow-up data from the IFN-K Phase I/IIa study"1 on Friday, September 4, 2015 in Vienna.

About the extended follow-up study of Phase I/IIa of IFNα-Kinoid in Lupus

Data was collected on six IFNα-Kinoid-treated patients included in the Phase I/IIa clinical trial of IFNα-Kinoid in SLE or lupus. Five of the six patients presented a positive IFN-signature at baseline. The same level of normalization of the IFN-signature as previously reported was observed in two out of five patients who developed neutralizing antibodies. Correlation in the increase of C3 serum level and neutralizing anti-IFNα antibodies also persisted in the same two patients, confirming previously reported results.

About Neovacs

Created in 1993, Neovacs is today a leading 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 five patent families that potentially run until 2032) Neovacs is focusing its clinical development efforts on IFNα-Kinoid, an immunotherapy being developed for the indication of lupus and dermatomyositis. Neovacs is also conducting preclinical development works on other therapeutic vaccines in the fields of auto-immune diseases, oncology and 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, please visit www.neovacs.fr

1 J. Ducreux, et Al, Lupus 2015, Poster Session P04 Treatment.

2 Neovacs has previously reported the strong level of biological activity of IFNα-Kinoid at 6 months after first immunization with IFNα-Kinoid. See Bernard Lauwerys et al., Down-Regulation of Interferon Signature in Systemic Lupus Erythematosus Patients by Active Immunization With Interferon –Kinoid, Arthritis & Rheumatism Vol. 65, No. 2, February 2013.

3 Kiefer K, Oropallo MA, Cancro MP, et al. Role of type I interferons in the activation of autoreactive B cells. Immunol Cell Biol 2012

CONTACT: NEOVACS - Investor Relations Nathalie Trepo +33 (0)1 53 10 93 00 ntrepo@neovacs.com Investor Relations / Financial Communications - NewCap Valentine Brouchot / Pierre Laurent +33 (0)1 44 71 94 94 neovacs@newcap.fr Investor Relations / Financial Communications Germany - MC Services Raimund Gabriel +49-89-210228-30 raimund.gabriel@mc-services.eu Press / U.S. Inquiries - The Ruth Group Melanie Sollid-Penton 1.646.536.7023 msollid@theruthgroup.com

Source:Neovacs, Inc.