NEOVACS obtains FDA "Fast Track" designation for IFNalpha Kinoid in Lupus (SLE)
December 07 2016 - 1:00AM
PRESS
RELEASE· PRESS
RELEASE· PRESS
RELEASE
Neovacs obtains
FDA "Fast Track" designation
for IFNalpha Kinoid in Lupus (SLE)
Paris and Boston,
December 7, 2016 - Neovacs (Alternext Paris: ALNEV), a leader
in active immunotherapies for the treatment of autoimmune diseases,
today announced that the U.S. Food and Drug Administration (FDA)
has granted "Fast Track" status to IFNalpha Kinoid in Lupus, the
most advanced therapeutic vaccine issued from Neovacs R&D.
The FDA's "Fast Track" designation
is granted to therapies in development that target severe diseases
or those that are life threatening and which have shown their
ability to address an unmet medical need, based on clinical data.
This status facilitates exchanges with the FDA, accelerates the
further product development and allows for a priority review of the
product registration file. As a result of this designation, Neovacs
has the best conditions to allow faster access to the IFNalpha
Kinoid for American patients.
Neovacs is currently enrolling
patients in an international Phase IIb trial (IFN-K 002) in Lupus
(SLE), an autoimmune disease that is chronic and very invalidating
and for which current treatments do not offer a satisfying therapy.
The objective of this trial is to measure biological and clinical
efficacy in moderate to severe SLE patients. This study, which has
already recruited more than half of its targeted 178 patients, is
underway in 21 countries in Europe, Asia, Latin America and the
United States.
Miguel Sieler,
CEO of Neovacs, commented: "This announcement
follows the IND obtained in April this year. It is the second
favourable notification by the FDA to Neovacs in the course of
2016. We are proud to receive once again from the FDA the
confirmation of the innovative character of our therapeutic
approach."
Dr. Therese
Croughs, CMO of Neovacs, added: "This "Fast
Track" designation reinforces our confidence in the therapeutic
potential of IFN Kinoid as a treatment for Lupus. Today, the
available treatments only aim to reduce the inflammation, to
alleviate the symptoms and are associated with significant side
effects."
About Neovacs
Technology
Neovacs targets pathologies associated with an overproduction of
endogenous cytokines. This technology is based on active
immunotherapy to generate an immune response through the
administration of an immunogenic complex involving the target
cytokine (for example IFNalpha, manufactured by 3P
Biotechnology) to a carrier protein (for example KLH, produced by our Partner Stellar Biotechnology).
The intramuscular injection of this Kinoid induces an immune
response and stimulates the production of polyclonal antibodies
against the target cytokines. It is thus possible to block cytokine
overproduction and its biological effects. Several autoimmune and
inflammatory diseases (systemic lupus erythematosus, psoriasis,
Type 1 diabetes etc.) are characterized by a disorder
of cytokines that are found produced in excess (ex: IFNa).
This overproduction will promote inflammation and dysregulation of
the immune system.
About
Neovacs
Listed on Alternext Paris since 2010, 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,
dermatomyositis and also in preclinical trial for Type 1 diabetes.
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. www.neovacs.fr
Contacts
NEOVACS - Corporate Communication & Investor
Relations
Charlène Masson
+33 (0)1 53 10 93 14
cmasson@neovacs.com
Investor Relations / Financial
Communications Germany - MC Services
Raimund Gabriel
+49-89-21-02-28-30
raimund.gabriel@mc-services.eu
Press / U.S. Inquiries - The Ruth
Group
Lee Roth / Joseph Green
+1-646-536-7012 / 7013
lroth@theruthgroup.com / jgreen@theruthgroup.com
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Source: NEOVACS via Globenewswire
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