Neovacs obtains FDA “Fast Track” designation for IFNα Kinoid in Lupus (SLE)
December 07 2016 - 2:15AM
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 IFNα 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 IFNα 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 TechnologyNeovacs
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
IFNα, 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 NeovacsListed 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 IFNα-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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