DBV Technologies Highlights Data Supporting Induction of Immunotolerance Through the Skin at Inflammatory Skin Disease Summit...
December 12 2018 - 1:30AM
Montrouge, France, December 12, 2018 |
DBV Technologies
Highlights Data Supporting Induction of Immunotolerance Through the
Skin at Inflammatory Skin Disease Summit 2018
First-of-its-kind
study evaluated immune profile of healthy human skin in different
body sites
Findings support
application of epicutaneous immunotherapy (EPIT) to inter-scapular
region of peanut-allergic patients for greater
allergen exposure
DBV Technologies (Euronext: DBV -
ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today announced that an oral abstract
evaluating differences in the immune profile of healthy human skin
across different body areas was presented by Dr. Ester Del Duca,
Icahn School of Medicine at Mount Sinai, at the 3rd
Inflammatory Skin Disease Summit (ISDS) in Vienna, Austria,
December 12-15, 2018.
The study results have important
implications for treating immunological disorders, such as food
allergies, with epicutaneous immunotherapy (EPIT). For food
allergies, EPIT is designed to target specific skin immune cells in
order to desensitize patients to allergens. In the study presented,
of the four body sites studied, the upper back region showed the
highest up-regulation of Th2/Th17 pathway genes and regulatory T
cells, which are important targets for preventing allergic
reactions. The findings support the use of the Company's
investigational Viaskin Peanut treatment for peanut allergy at the
inter-scapular region of the upper back due to the local immune
profile of the skin.
"We are proud to support leading research that helps characterize the significant
potential of the skin as the largest immune organ and contributes
to our growing understanding of how to best treat food allergies
and other immunological diseases," said Dr.
Hugh Sampson, Chief Scientific Officer of
DBV Technologies and Kurt Hirschhorn Professor of Pediatrics at the
Icahn School of Medicine at Mount Sinai. "The data presented at ISDS 2018
suggest that the specific immune environment of the skin on the
back has the greatest potential to induce immunotolerance in
patients with food allergies compared with other areas of the body
explored in this study. Such data help
ensure that novel treatments are optimized in the real-world and
further support the therapeutic benefit that children with peanut allergy may receive from treatment
with Viaskin Peanut, which is applied directly to the upper
back."
In an oral presentation entitled,
"Major Differences in
Expression of Inflammatory Products in Skin from Different Body
Sites of Healthy Individuals" (#A67), Dr.
Ester Del Duca, from the laboratory of Dr. Emma Guttman at Icahn
School of Medicine at Mount Sinai, New York, NY, presented findings
showing significant differences in the distribution of cell types
and immune profile of the skin across different body areas from
healthy individuals. Out of the four locations studied - inner
upper arm, upper back, outer upper thigh and lower abdomen - the
upper back region showed the highest up-regulation of Th2/Th17
pathway genes and regulatory T cells, important targets for
preventing an allergic reaction. The back also had the highest
number of dendritic cells and Langerhans cells, as well as the
lowest expression of negative immune regulators, which together can
support better immune recognition of antigens when treated with
EPIT.
In October 2018, DBV Technologies
submitted a Biologics License Application to the U.S. Food and Drug
Administration for Viaskin Peanut for the treatment of peanut
allergy in children four to 11 years of age. Viaskin Peanut is the
Company's lead product candidate, which is based on epicutaneous
immunotherapy (EPIT), a proprietary technology platform that
delivers biologically active compounds to the immune system through
the skin. Viaskin Peanut previously received Breakthrough and Fast
Track Designation from the FDA. The submission was supported by a
global development in children four to 11 years of age, in which
treatment with Viaskin Peanut 250 µg was observed to demonstrate a
significant desensitization to peanut as compared to placebo.
About DBV Technologies
DBV Technologies is developing
Viaskin®, a proprietary technology platform with broad potential
applications in immunotherapy. Viaskin is based on epicutaneous
immunotherapy, or EPIT®, DBV's method of delivering biologically
active compounds to the immune system through intact skin. With
this new class of self-administered and non-invasive product
candidates, the Company is dedicated to safely transforming the
care of food allergic patients, for whom there are no approved
treatments. DBV's food allergies programs include ongoing clinical
trials of Viaskin Peanut and Viaskin Milk, and preclinical
development of Viaskin Egg. DBV is also pursuing a human
proof-of-concept clinical study of Viaskin Milk for the treatment
of Eosinophilic Esophagitis, and exploring potential applications
of its platform in vaccines and other immune diseases. DBV
Technologies has global headquarters in Montrouge, France and New
York, NY. The Company's ordinary shares are traded on segment A of
Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the
SBF120 index, and the Company's ADSs (each representing one-half of
one ordinary share) are traded on the Nasdaq Global Select Market
(Ticker: DBVT).
Forward Looking
Statements
This press release may contain
forward-looking statements and estimates, including statements
regarding the potential of Viaskin Peanut as a treatment for peanut
allergic children. These forward-looking statements and estimates
are not promises or guarantees and involve substantial risks and
uncertainties. At this stage, the products of the Company have not
been authorized for sale in any country. Among the factors that
could cause actual results to differ materially from those
described or projected herein include uncertainties associated
generally with research and development, clinical trials and
related regulatory reviews and approvals, the risk that results of
historical clinical trials will not be replicated in future
clinical trials and the risk that historical clinical results in
one patient population may not be predictive of future clinical
trial results in different patient populations. A further list and
description of these risks, uncertainties and other risks can be
found in the Company's regulatory filings with the French Autorité
des Marchés Financiers, the Company's Securities and Exchange
Commission filings and reports, including in the Company's Annual
Report on Form 20-F for the year ended December 31, 2017 and future
filings and reports by the Company. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements and estimates, which speak only as of
the date hereof. Other than as required by applicable law, DBV
Technologies undertakes no obligation to update or revise the
information contained in this Press Release.
DBV Investor
Relations Contact
Sara Blum Sherman
Senior Director, Investor Relations & Strategy
+1 212-271-0740
sara.sherman@dbv-technologies.com
DBV Media
Contact
Joe Becker
VP, Global Corporate Communications
+1 646-650-3912
joseph.becker@dbv-technologies.com
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This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: DBV Technologies via Globenewswire
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