DBV Technologies Announces Publication of Experimental Data on Targeted Regulatory T Cell Induction during Epicutaneous Immunotherapy
(Thomson Reuters ONE) -
Press Release
Montrouge, France, April 11, 2016
DBV Technologies Announces Publication of Experimental Data on Targeted
Regulatory T Cell Induction during Epicutaneous Immunotherapy
Publication in Cellular & Molecular Immunology Shows that Desensitization with
EPIT(®) Induces Tregs with Specific Homing Properties
Compared to Other Methods Studied, Scientific Data Shows that Only EPIT Retains
Suppressive Ability After Treatment Discontinuation
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market:
DBVT), a clinical-stage specialty biopharmaceutical company, today announced the
publication of experimental data in Cellular & Molecular Immunology
characterizing the response of regulatory T cell (Tregs) to allergen-specific
immunotherapy intended for the treatment of food allergies. The study
characterized Tregs activity during Epicutaneous Immunotherapy (EPIT), oral
immunotherapy (OIT) and sublingual immunotherapy (SLIT), and showed that all
methods of treatment desensitized peanut-sensitized mice, but only EPIT-induced
Tregs continued to show suppressive abilities after treatment discontinuation.
DBV Technologies is developing Viaskin®, a proprietary technology that uses EPIT
to deliver allergenic compounds targeting the immune system through the immune
cells of intact skin, the Langerhans cells in the epidermis.
"Although EPIT, OIT and SLIT were all able to desensitize peanut-allergic mice,
only EPIT-induced Tregs maintained suppressive activities after treatment was
stopped," explained Dr. Lucie Mondoulet, Deputy Chief Scientific Officer, DBV
Technologies. "Knowing that maintaining suppression ability after treatment may
lead to the induction of long-term tolerance, we are now working to confirm
these experimental data through our ongoing clinical trials with Viaskin."
The study, "Differences in Phenotype, homing properties and suppressive
activities of Regulatory T cells induced by Epicutaneous, Oral or Sublingual
Immunotherapy in Mice Sensitized to Peanut", showed that peanut desensitization
with EPIT, OIT, and SLIT induce different Tregs subsets with differing homing
properties, consequently inducing distinct long-term efficacy and maintenance
ability in vivo. The three immunotherapy routes studied were all found to have a
desensitization effect, but suppressive activities after discontinuation of
treatment were only observed with EPIT, and not with OIT or SLIT. Tregs observed
during OIT and SLIT showed only an effector/memory cell profile, while Tregs
during EPIT showed both effector/memory and naive cell profiles. These "naive"
Tregs appear to induce sustained suppression after discontinuation of treatment,
suggesting the induction of a longer-lasting allergen tolerance in a mice model.
The study was published in Cellular & Molecular Immunology and is now available
via Open Access at
http://www.nature.com/cmi/journal/vaop/ncurrent/full/cmi201614a.html.
Food allergies affect approximately 15 million Americans and 17 million
Europeans, with the majority of patients being young children. There is
currently no approved treatment other than dietary avoidance and the
availability of self-injectable epinephrine.
Study Details
To study efficacy and characterization of Tregs induced by the different
therapies, mice sensitized with peanut protein extract (PPE) were randomly
allocated to four groups of eight and treated for eight weeks: EPIT (100 µg),
OIT (1 mg the first week, 2 mg the second week, then 5 mg the following 6
weeks), SLIT (100 µg) and a placebo group. Allergen specific responses as well
as Treg phenotypes were analyzed using blood and tissue samples. To examine the
transfer of protection by Tregs, mice were randomly allocated to six groups of
15 animals and treated for eight weeks: two groups treated by EPIT, two treated
by SLIT and two groups treated by OIT. Following treatment, or 8 weeks after
the end of treatment, one group treated with each form of immunotherapy were
sacrificed for spleen cell recovery and CD4(+)CD25(+) cell sorting. Cells were
then transferred into peanut-sensitized non-treated mice (n=8 per group). Three
days after the transfer, mice were orally exposed to peanuts daily for 10 days.
A tissue analysis of esophagus was then conducted to assess the protection
conferred by passive Tregs transfer.
About DBV Technologies
DBV Technologies is developing Viaskin®, an innovative new approach to the
treatment of allergies - a major public health issue that has been increasing in
prevalence. DBV Technologies, incorporated in France in 2002, has developed a
proprietary, patented technology for administering an allergen to intact skin
while avoiding transfer to the blood, and thus lowering the risk of a systemic,
allergic reaction in the event of accidental exposure. DBV Technologies is
focusing on food allergies, including milk and peanut, for which there are
currently no effective treatments. DBV Technologies has designed two products
candidates: Viaskin® Peanut and Viaskin® Milk. The clinical development program
for Viaskin® Peanut has received Fast Track designation and Breakthrough Therapy
designation from the U.S. Food and Drug Administration.
DBV Technologies shares are traded on segment B of Euronext Paris (Ticker: DBV,
ISIN code: FR0010417345) and on the Nasdaq Stock 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 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, 2014 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/2002409/738952.pdf
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: DBV Technologies via GlobeNewswire
[HUG#2002409]
Unternehmensinformation / Kurzprofil:
Datum: 11.04.2016 - 22:31 Uhr
Sprache: Deutsch
News-ID 463236
Anzahl Zeichen: 9463
contact information:
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Kategorie:
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