DBV Technologies Announces Publication of Preclinical Data in JACI Suggesting EPIT® Provides Sustained Protection Against Anaphylaxis
(Thomson Reuters ONE) -
Press Release
Montrouge, France, June 13, 2016
DBV Technologies Announces Publication of Preclinical Data in JACI Suggesting
EPIT(®) Provides Sustained Protection Against Anaphylaxis
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market:
DBVT), a clinical-stage specialty biopharmaceutical company, today announced the
publication of preclinical data in the Journal of Allergy and Clinical
Immunology (JACI) suggesting that, independent of the route of sensitization,
treatment with Epicutaneous Immunotherapy (EPIT) provides protection against
food-induced anaphylaxis during therapy and after treatment discontinuation in
animal models. The publication is now available at www.jacionline.org under
"Articles in Press".
"For the first time, we were able to show that the epicutaneous route of
delivery provided protection from food-induced anaphylaxis, and by supporting
the development of gut-homing LAP+ Tregs, EPIT was observed to suppress mast
cell activation leading to sustained clinical protection," said Dr. Cecilia
Berin, PhD, co-author of the publication. "These new data show that the unique
immune communication between skin and gastrointestinal tract can be used to
generate long-lasting protection from food allergies, and shed light on why we
do not observe a sustained treatment response with other routes of
immunotherapy."
The publication, "Epicutaneous immunotherapy induces Gastrointestinal LAP +
Tregs and prevents food-induced anaphylaxis", details an independent study
conducted by a team of researchers led by Dr. Cecilia Berin, PhD, Associate
Professor, Pediatric & Allergy & Immunology, Icahn School of Medicine at Mount
Sinai University, which compares the outcome of food allergy immunotherapy with
EPIT and oral immunotherapy (OIT). Findings show that when mice were challenged
after four weeks without treatment, EPIT-treated mice were still significantly
protected while mice treated with OIT regained clinical reactivity, independent
of the initial route of sensitization. In this study, Treg generation with OIT
was impaired in allergic mice, which led to the lack of sustained protection
after OIT was discontinued. In mice treated with EPIT, the skin-gut immune
communication generated gut-homing, antigen-specific LAP+Foxp3-Tregs that
directly suppressed systemic anaphylaxis and provided sustained protection after
treatment discontinuation.
Food allergies affect approximately 15 million Americans and 17 million
Europeans, with the majority of patients being young children. No approved
treatment option exists for food allergic patients. Standard of care remains
strict avoidance and the use of epinephrine to manage symptomatic life-
threatening reactions.
Study Details
To determine the efficacy and mechanism of tolerance induced by EPIT, mice
sensitized to ovalbumin (OVA) received either EPIT (100 µg) via Viaskin® patches
once per week or OIT (1mg) once daily for eight weeks. Tissue and blood samples
were analyzed along with symptom monitoring to assess protection. At the end of
treatment, both EPIT and OIT-treated mice were protected, however when
challenged again to test sustained protection after four weeks without
treatment, only those which were treated with EPIT were still significantly
protected. The protection against anaphylaxis was mediated via a TGF-beta-
dependent mechanism, which directly suppresses mast cell activation in the
absence of modulation of T or B cell responses.
About DBV Technologies
DBV Technologies developed 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 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.
Company shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN
code: FR0010417345), part of the SBF120 index, and traded on the Nasdaq Global
Select Market in the form of American Depositary Shares (each representing one-
half of one ordinary share) (Ticker: DBVT). For more information on DBV
Technologies, please visit our website: www.dbv-technologies.com
Forward Looking Statements
This press release contains forward-looking statements, including statements
about the potential safety and efficacy of Epicutaneous Immunotherapy (EPIT®)
via Viaskin®. These forward-looking statements that are not promises or
guarantees and involve substantial risks and uncertainties. The Company's
product candidates have not been approved for sale in any jurisdiction. Among
the factors that could cause actual results to differ materially from those
described or projected herein are uncertainties associated generally with
research and development, clinical trials and related regulatory reviews and
approvals, the risk that historical preclinical results may not be predictive of
future clinical trial results, and the risk that historical clinical trial
results may not be predictive of future trial results. 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, 2015 and future filings and reports by the Company. Existing and prospective
investors are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. DBV Technologies undertakes
no obligation to update or revise the information contained in this Press
Release, whether as a result of new information, future events or circumstances
or otherwise.
DBV Technologies Contact
Susanna Mesa
Senior Vice President, Strategy
Tel. : +1 212-271-0861
susanna.mesa(at)dbv-technologies.com
DBV Technologies Media Contacts US & Europe
Marion Janic Caroline Carmagnol
Rooney & Associates Alize RP - Relation Presse
Tel. : +1-212-223-4017 Tel. : +33(0)6 64 18 99 59
mjanic(at)rooneyco.com caroline(at)alizerp.com
Erinn White
Centron PR
Tel. : +1-646-722-8822
ewhite(at)centronpr.com
PDF Version:
http://hugin.info/156437/R/2019881/750014.pdf
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: DBV Technologies via GlobeNewswire
[HUG#2019881]
Unternehmensinformation / Kurzprofil:
Datum: 13.06.2016 - 07:30 Uhr
Sprache: Deutsch
News-ID 477116
Anzahl Zeichen: 8502
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