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DBV Technologies and INRA Receive Funding to Develop Pediatric Bronchiolitis ('RSV') Vaccine: RSV-NanoViaSkin
BAGNEUX, France --(Business Wire)--
Regulatory News:
DBV Technologies (Euronext: DBV - ISIN: FR0010417345) (Paris:DBV),
creator of Viaskin®, a new standard in the treatment of allergies,
announced today that the Company and the French Institute for
Agricultural Research-INRA (Molecular Virology and Immunology Unit,
VIM-U892) have been awarded a research grant of nearly �600.000 from the
French National Research Agency (ANR) to develop an innovative,
efficient and safe pediatric 'RSV' bronchiolitis ('RSV') vaccine.
RSV-NanoViaSkin is intended to become the world's first non-invasive and
adjuvant-free epicutaneous RSV pediatric vaccine.
Respiratory syncytial virus is the major cause of lower
respiratory tract infection in infants and children. It is highly
contagious, and it is estimated that 95% of children test seropositive
for RSV by two years of age. Outbreaks occur annually throughout the
world. Symptomatic infections may recur because natural RSV infection
produces limited immunity.
Dr. Pierre-Henri Benhamou, Chairman and CEO of DBV Technologies,
said: "We are very proud to announce this new collaboration with INRA
and especially the VIM unit. Indeed, this partnership represents
undoubtedly a real breakthrough on multiple fronts, notably because two
cutting edge technologies are associated to address newborns, a very
vulnerable patient population. DBV is thereby positioned to fulfill
another very high unmet medical need: there is a growing concern that
severe RSV infections may adversely affect pulmonary development and
lead to long-term respiratory problems for infants and children; infants
who are exposed to even mild RSV-diseases are at much higher risk to
develop recurrent wheeze and asthma up to their teenage years. There is
no doubt that a safe, painless and effective RSV vaccine in the first
six months of life would be a major advance in reducing the severe
burden of respiratory diseases and hospitalization. Once again, Viaskin®
reveals its versatility and amazing capacity to induce a protecting
immune profile without adjuvant."
Dr. Sabine Riffault, Scientist and deputy director of VIM-U892 at
INRA, said, "We are very proud that our efforts to put this
project together with DBV Technologies are finally successful. We
believe in the strength of our partnership based upon complementary
skills that together will open the way to a new generation of pediatric
vaccine delivered via the skin and targeting for the first time RSV
bronchiolitis. We are addressing with special care all the delicate
issues of pediatric vaccination, favoring a non invasive administration
of safe non replicating antigens."
DBV Technologies has developed and patented the Viaskin® technology
which appears to be totally adapted to the development of a new RSV
vaccine, for infants. Indeed, the Viaskin® technique allows epicutaneous
application of the vaccine (non-traumatic for 0-6 months newborn babies,
efficient in stimulating the immune system) and compensates the lack of
adequate response of the intranasal injection route of administration.
The RSV-NanoViaSkin project aims at delivering a pre-clinical-proof of
concept for a novel efficient and safe pediatric SV vaccine that is
able to find original solutions to all problems of current RSV
vaccination strategies, in a 30-month study. The project aims at
developing a full pre-clinical package in several animal models. The
INRA innovation stands around a new immunogenic antigen (N-eF proteins),
targeting CTL and neutralizing antibody-mediated immunity to RSV, using
well characterized immunogenic nanostructures (Nring) decorated with
epitopes from the fusion protein based on patented/published
pre-clinical results, carried out by VIM-INRA. The epicutaneous route of
administration using Viaskin® enables to overcome the hurdles of
interference of maternal antibodies and the immaturity of the immune
system.
About RSV
Respiratory syncytial virus (RSV) is a very common virus that leads to
mild, cold-like symptoms in adults and older healthy children. It can be
more serious in young babies, especially to those in certain high-risk
groups. RSV is the most common germ that causes lung and airway
infections in infants and young children. Most infants have had this
infection by age 2. Outbreaks of RSV infections most often begin in the
fall and run into the spring. The infection can occur in people of all
ages. RSV often spreads very rapidly in crowded households and day care
centers. The virus can live for half an hour or more on hands. The virus
can also live for up to 5 hours on countertops. Infants under age 1 may
have more severe symptoms and often have the most trouble breathing.
Antibiotics do not treat RSV. Mild infections go away without treatment.
Infants and children with a severe RSV infection may be admitted to
hospital. In young children, RSV can cause bronchiolitis, croup, ear
infections, lung failure and pneumonia. Children who have had RSV
bronchiolitis may be more likely to develop asthma.
About VIM-INRA
The Molecular Virology and Immunology Unit (VIM-U892) is part of the
Animal Health division at INRA. VIM-U892 studies�pathogens
affecting farm animals, some of them being zoonotic pathogens.�Our
research activities range from the molecular characterization of
pathogens to host-defense mechanisms. We are mainly interested in respiratory
viruses in mammals and birds, fish viruses and bacteria, and
non-conventional agents such as prions. We study host-pathogen
interactions in target species (swine, cattle, sheep, trout) or model
species (mice, zebra fish).
Our main scientific issues are:
1) Structure and expression of pathogen genomes
2) Structure-function relationships of macro-molecular complexes
3) Virulence-pathogenicity factors and escape from host defenses
4) Plasticity of host responses during evolution and development
5) Fighting strategies: vaccination and therapeutical approaches
For more information, please visit our website: www.jouy.inra.fr/vim
About DBV Technologies
DBV Technologies is opening up a decisive new approach to the treatment
of allergy - a major public health issue that is constantly increasing
in prevalence. Food allergies represent a true handicap in everyday life
for millions of people and thus constitute a major unmet medical need.
DBV Technologies has developed a unique, proprietary, worldwide-patented
technology for administering an allergen to intact skin and avoiding
massive transfer to the blood. The Viaskin® technology combines efficacy
and safety as part of a treatment that seeks to improve the patient's
tolerability of peanut and thus considerably lower the risk of a
systemic, allergic reaction in the event of accidental exposure to the
allergen. The company's significant development program has taken this
revolutionary method through to the industrial stage in Europe,
initially. The product's clinically proven safety of use enables the
application of effective desensitization techniques (the efficacy of
which is acknowledged worldwide) in the most severe forms of the
allergy. DBV Technologies is focusing on food allergies (milk and
peanut) for which there are currently no effective treatments. It has
developed two products: Viaskin® Peanut and Viaskin® Milk. The clinical
development program for Viaskin® Peanut has received Fast Track
designation from the US Food and Drug Administration. The company will
subsequently develop a Viaskin® patch for young children with house dust
mite allergy - a true public health issue because this pathology is one
of the main risk factors for childhood asthma. DBV Technologies shares
are traded on segment C of Euronext Paris (Ticker: DBV, ISIN code:
FR0010417345).
For more information on DBV Technologies, please visit our website: www.dbv-technologies.com.
CAUTION: Viaskin® is not approved for sale in the USA.
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein
are based on the Company's management strategy, current views and
assumptions. Such statements involve known and unknown risks and
uncertainties that may cause actual results, performance or events to
differ materially from those anticipated herein. Furthermore, the
Research and Development process involves several stages each of which
involve the substantial risk that the Company may fail to achieve its
objectives and be forced to abandon its efforts with regards to a
product in which it has invested significant sums. Therefore, the
Company cannot be certain that favorable results obtained during
pre-clinical trials will be confirmed subsequently during clinical
trials, or that the results of clinical trials will be sufficient to
demonstrate the safe and effective nature of the product concerned. DBV
technologies' business is subject to the risk factors outlined in its
registration documents filed with the French Autorit� des March�s
Financiers.

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