Neovacs Initiates Clinical Program in Dermatomyositis

  • Extension of IFNα-Kinoid program to include Dermatomyositis
  • Formation of Clinical Advisory Board
  • Anticipated trial launch early 2016

PARIS and BOSTON, June 16, 2015 (GLOBE NEWSWIRE) -- NEOVACS (Alternext Paris:ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced the launch of its clinical development program in Dermatomyositis (DM), an orphan skin and muscular condition with significant unmet medical need.

Neovacs is extending its IFNα-Kinoid clinical program beyond lupus to include adult and pediatric DM – an indication where a positive IFNα signature plays a decisive role1. The decision follows a recommendation earlier this year by the Company's Scientific Advisory Board to pursue IFNα-Kinoid as a potential treatment for DM and extensive due diligence in researching IFN-related diseases that could benefit from this treatment modality. Neovacs plans to conduct a multicentric phase I/IIa trial of IFNα-Kinoid in adult DM in 15 patients which is anticipated to launch in early 2016 in France and other European countries.

"Dermatomyositis demonstrates a promising therapeutic candidate pipeline expansion, given the demonstrated role of IFNα in this auto-immune disease. As DM is an orphan condition, this is also an opportunity to bring needed relief to thousands of patients, most of them children, for whom there is currently no satisfactory biotherapy," commented Miguel Sieler, CEO of Neovacs. "We believe that the IFNα-Kinoid in DM will be a development driver for Neovacs, with a limited impact on expenditures. Neovacs will apply for grants dedicated to rare diseases to support the funding of the DM program."

DM is an inflammatory disease characterized by severe skin lesions and muscle weakness with a variable impact on physical capacities. DM can also affect the vascular, pulmonary, gastrointestinal and cardiac systems. Approximately one third of DM patients will develop cancer within three years2. DM affects primarily children, and mostly females. No biological treatment has been registered to date in this indication.

With a prevalence between 1 in 50,000 and 1 in 10,000 cases3, DM is considered an orphan disease both in North America and in Europe. It is estimated that there are currently approximately 87,000 patients4 with DM in the EU. Because of the recognized orphan status of DM, Neovacs estimates that clinical development of IFNα-Kinoid in this indication could be considerably shortened, with the potential to bring a treatment to patients in a few years.

Formation of a Clinical Advisory Board

To sustain and support it in this endeavor, Neovacs has formed a cross disciplinary Clinical Advisory Board (CAB) composed of leading experts in DM:

  • Prof. Olivier Benveniste, M.D., Ph.D.,
    Hôpital Pitié-Salpêtrière, Paris
  • Prof. Eric Hachulla, M.D., Ph.D.,
    Centre Hospitalier Regional Universitaire de Lille, France
  • Dr. Jean-David Bouaziz, M.D.,Ph.D.,
    Hôpital Saint-Louis, Paris
  • Prof. Werner Stenzel, M.D. ,Ph.D.,
    Charité Universitätmedizin Berlin
  • Prof. Ingrid Lundberg, M.D.,
    Karolinska Universitetssjukhuset, Stockholm

These board members will be instrumental not only in bringing their expertise to Neovacs in preparing for and defining the metholodology, target population, and evaluation criteria for the DM trial, but also in assisting with trial development and patient recruitment.

The IFNα-Kinoid program in DM could be initiated as early as 2016.

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.

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1 Baechler, ART 2011; Wong, Plos One 2012; Greenberg, Genes immun 2012; Shiba, Rheumatol Int 2014
3 Ibid
4 Estimated population assessed taking into account a 1.7/10,000 prevalence in the European Union, and a total EU population of 511,100,000 (Eurostat 2014). Source: EMA/COMP/660609/2014, 12 January 2015

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Source:Neovacs, Inc.