Legal Proceedings Report • Sep 9, 2015
Legal Proceedings Report
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PRESS RELEASE PRESS RELEASE PRESS RELEASE
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 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.
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
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.
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
Contacts
NEOVACS – Investor Relations Nathalie Trépo +33 (0)1 53 10 93 00 [email protected]
Investor Relations / Financial Communications – NewCap Valentine Brouchot / Pierre Laurent +33 (0)1 44 71 94 94 [email protected]
Investor Relations / Financial Communications Germany – MC Services Raimund Gabriel +49-89-210228-30 [email protected]
Press / U.S. Inquiries – The Ruth Group Melanie Sollid-Penton 1.646.536.7023 [email protected]
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