Neovacs : CONFIRMS POTENT AND LONG-LASTING BIOLOGICAL ACTIVITY OF IFNalpha-KINOID 4 YEARS AFTER PATIENT DOSING IN PHASE I/IIa TRIAL

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NEOVACS CONFIRMS POTENT AND LONG-LASTING BIOLOGICAL ACTIVITY OF IFNalpha-KINOID 4 YEARS AFTER PATIENT DOSING IN PHASE I/IIa TRIAL

Company presented extended follow-up data on IFNalpha-Kinoid
at 11^th international congress on Lupus

Paris and Boston, September 9, 2015 - 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 IFNalpha-Kinoid during Lupus 2015, the 11^th 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-IFNalpha response in SLE patients. This is an extremely positive sign as we are about to launch the Phase IIb trial of IFNalpha-Kinoid in SLE" commented Thérèse Croughs, M.D., Chief Medical Officer of Neovacs.  

This new data^[1]:
#_ftn1, collected as part of the Phase I/IIa extended follow-up study of six IFNalpha-Kinoid-treated patients, demonstrates that anti-IFNalpha neutralizing antibodies generated by IFNalpha-Kinoid continue to be present four years after the first immunization, and maintain the normalization of the IFNalpha signature. This confirms previously reported results^[2]:
#_ftn2. 

The study also highlights the association between anti-IFNalpha neutralizing antibodies and the decreased expression of induced genes associated with B cell activation. B-cell activation, like the IFNalpha-signature, has been linked to the pathogenesis of SLE lupus.^[3]:
#_ftn3

Follow up data from the Phase I/IIa clinical trial was presented in the poster "IFNalpha-kinoid (IFN-K) induces neutralizing anti-IFNalpha 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 IFNalpha-Kinoid in Lupus
Data was collected on six IFNalpha-Kinoid-treated patients included in the Phase I/IIa clinical trial of IFNalpha-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-IFNalpha 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 IFNalpha-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

Contacts
                                                              
NEOVACS - Investor Relations
Nathalie Trépo
+33 (0)1 53 10 93 00
ntrepo@neovacs.com:
mailto:ntrepo@neovacs.com

Investor Relations / Financial Communications - NewCap
Valentine Brouchot / Pierre Laurent
+33 (0)1 44 71 94 94
neovacs@newcap.fr:
mailto:neovacs@newcap.fr

Investor Relations / Financial Communications Germany - MC Services
Raimund Gabriel
+49-89-210228-30
raimund.gabriel@mc-services.eu:
mailto:raimund.gabriel@mc-services.eu

Press / U.S. Inquiries - The Ruth Group
Melanie Sollid-Penton
1.646.536.7023
msollid@theruthgroup.com:
mailto:msollid@theruthgroup.com