DBV Technologies to Present New Data at the 2016 AAAAI Annual Meeting
February 10, 2016: 09:01 AM ET
2-Year Follow-Up of Clinical Data Further Support Viaskin® Peanut's Efficacy and Safety Profile
Research Results Provide Additional Insights into EPIT®'s Differentiated Mechanism of Action and Highlight the Broad Viaskin Platform
MONTROUGE, France, Feb. 10, 2016 (GLOBE NEWSWIRE) -- DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage specialty biopharmaceutical company, today announced that nine abstracts on Epicutaneous Immunotherapy (EPIT) have been selected for presentation at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Los Angeles, CA, March 4-7, 2016. All abstracts are available online at http://annualmeeting.aaaai.org/, and will also be published in a supplement to the February Journal of Allergy and Clinical Immunology (JACI) http://www.jacionline.org/.
In addition to the clinical and scientific publications which will be presented as part of the 2016 AAAAI Annual meeting by DBV:
On Friday, March 4, two additional oral presentations featuring new EPIT data will be highlighted during the Allergen Immunotherapy, Today and Tomorrow: Session II. Immunotherapy with Food Allergens educational session.
On Sunday, March 6, DBV Technologies will host a Symposium, "Epicutaneous Immunotherapy - A Novel Pathway for The Treatment of Food Allergies" from 6:30 - 8:30 PM at the Diamond Ballroom Level, Salon 4 at the JW Marriott Los Angeles L.A. LIVE. The Symposium will be broadcasted live and archived online at http://www.dbv-technologies.com/en/news-events/scientific-congresses.
"We are extremely proud of the breadth and quality of results we will be presenting at AAAAI this year," said Dr.Pierre-Henri Benhamou, Chairman and Chief Executive Officer of DBV Technologies. "We are committed to accelerating therapeutic innovation in food allergy diseases, for which there are no approved treatments. Our AAAAI data continues to demonstrate that DBV combines deep science and robust clinical development in order to bring safe, effective and convenient therapies to our patients."
Presentations in Peanut Allergy Clinical Data
"Enhanced Efficacy and Confirmed Safety of a Two-Year Epicutaneous Immunotherapy (EPIT) Treatment of Peanut Allergy with Viaskin® Peanut: The Continuation of the VIPES Phase IIb Randomized Controlled Trial" will be presented by Dr. Hugh Sampson, Chief Scientific Officer, DBV Technologies. After previously announcing that the 12-month VIPES trial met its primary endpoint, two-year follow up data showed increasing response rates with Viaskin Peanut over time. The response rates after 24 months of EPIT with Viaskin Peanut 250 µg were 69.7% overall and 80.0% in children 6-11 years, compared to 50% overall and 53.6% in children after 12 months. Adolescents and adults treated remained stable.
Oral Presentation
Session Number: 3611
Poster Number: L59
Session Title: Clinical/Translational Sciences
Date/Time: Sunday, March 6 / 2:00 PM to 3:15 P
FARRP (Food Allergy Research & Resource Program) Presentation
"Quantitative Assessment of the Safety Benefits Associated with Increasing Clinical Peanut Thresholds through Immunotherapy" will be presented by Dr. Joe Baumert, Associate Professor in the University of Nebraska, Department of Food Science and Technology. Using risk modeling, this study was designed to determine the level of protection against accidental exposure to undeclared peanut residue in food after partial desensitization. Dr. Baumert concluded that reaching a threshold dose of 300 mg peanut protein would be a key milestone in the treatment of highly peanut-sensitive individuals.
Poster Session
Session: 3206
Poster Number: 417
Session Title: Food Allergy: Diagnosis and Management
Date/Time: Sunday, March 6 / 9:45 AM to 10:45 AM
CoFAR (Consortium of Food Allergy Research) Presentations
"Epicutaneous Peanut to Treat Peanut Allergy" will be presented by Dr. Stacie Jones, Chair of National Institute of Allergy and Infectious Diseases' Consortium of Food Allergy Research (CoFAR).
o Oral Presentation
o Session Number: 1201
o Session Title: Allergen Immunotherapy, Today and Tomorrow: Session II. Immunotherapy with Food Allergens
o Date/Time: Friday, March 4 / 10:00 AM to 10:30 AM
"Insights from New Mechanistic Studies on Food Allergy" will be presented by Dr. Cecilia Berin, Associate Professor Pediatrics, Mount Sinai Hospital in New York, NY.
o Oral Presentation
o Session Number: 1201
o Session Title: Allergen Immunotherapy, Today and Tomorrow: Session II. Immunotherapy with Food Allergens
o Date/Time: Friday, March 4 / 10:30 AM to 11:00 AM Clinical Data in Cow's Milk Allergy
"Safety of Viaskin Milk Epicutaneous Immunotherapy (EPIT) in IgE-Mediated Cow's Milk Allergy (CMA) in Children (MILES Study)" will be presented by Dr. Karine Rutault, DBV Technologies. In Part A of this study, 18 children ages 2-17 were enrolled to explore the safety of three different doses of Viaskin Milk (150 µg, 300 µg or 500 µg) when compared to placebo. No safety concerns were observed.
o Poster Session
o Session Number: 3206
o Poster Number: 437
o Session Title: Food Allergy: Diagnosis and Management
o Date/Time: Sunday, March 6 / 9:45 AM to 10:45 AM
Presentation on the Use of the Platform in Hemophilia A
"Epicutaneous Immunotherapy Using Plasma-Derived Factor VIII Reduces the Inhibitory Immune Response to Therapeutic Factor VIII in Experimental Hemophilia A" will be presented by Dr. Sebastien Lacroix-Desmazes, Director of Research, INSERM, Immunopathology and Therapeutic Immuno-Intervention Section. In this study, epicutaneous exposure to pdFVIII of hemophilic mice sensitized to FVIII was observed to reduce immune response to therapeutic FVIII during replacement therapy.
Oral Presentation
Session Number: 2602
Poster Number: 289
Session Title: From the Bench to the Bedside, When Clinical and Basic Science Research Advance Clinical Care
Date/Time: Saturday, March 5 / 2:30 PM to 2:45 PM
Research Presentations on EPIT's Mechanism of Action
"EPIT Prevents from the Induction of Anaphylaxis to Further Allergens: Role of Naïve Tregs" will be presented by Dr. Lucie Mondoulet, Deputy Chief Scientific Officer at DBV Technologies. This preclinical study examines the role of Regulatory T Cells (Tregs) during allergen immunotherapy with EPIT. Dr. Mondoulet observed that naive Tregs, induced by EPIT, seem to confer protection against sensitization to further allergens.
Poster Session
Session Number: 2210
Poster Number: 195
Session Title: Immunotherapy, Anaphylaxis
Date/Time: Saturday, March 5 / 9:45 AM to 10:45 AM
"No Impact of Filaggrin Deficiency on EPIT Efficacy in a Murine Model" will be presented by Dr. Sophie Wavrin, DBV Technologies. Results of this preclinical study show that EPIT remains efficacious and safe in the presence of Filaggrin polymorphism or mutations.
Poster Session
Session Number: 3206
Poster Number: 438
Session Title: Food Allergy: Diagnosis and Management
Date/Time: Sunday, March 6 / 9:45 AM to 10:45 AM
"Epicutaneous but Not Oral Immunotherapy Leads to Sustainable GATA-3 Hypermethylation and Foxp3 Hypomethylation in Peanut Sensitized Mice" will be presented by Dr. Jorg Tost, Head of Laboratory for Epigenetics and Environment (LEE), the National Genotyping Center, Genomics Institute/CEA. To gain a fuller understanding of EPIT's mechanism of action, this animal model studied the biochemical reaction of changes in gene expression with EPIT compared to changes with oral immunotherapy (OIT).
Poster Session
Session Number: 3206
Poster Number: 422
Session Title: Food Allergy: Diagnosis and Management
Date/Time: Sunday, March 6 / 9:45 AM to 10:45 AM
"Sustainability of Phenotype and Suppressive Activities of Tregs After Discontinuation of EPIT but Not of OIT or SLIT in Peanut Sensitized Mice" will be presented by Dr. Vincent Dioszeghy, DBV Technologies. With the hypothesis that Tregs can help induce long-term tolerance, this experiment measured Treg activity during treatment with EPIT, OIT and sublingual immunotherapy (SLIT). Tregs induction was observed during OIT and SLIT, but only EPIT-induced Tregs were maintained after the discontinuation of treatment, suggesting that EPIT may induce tolerance.
Poster Session
Session Number: 3206
Poster Number: 415
Session Title: Food Allergy: Diagnosis and Management
Date/Time: Sunday, March 6 / 9:45 AM to 10:45 AM
"Three Complementary Pathways Characterize the Suppressive Properties of EPIT-Induced Tregs" will be presented by Dr. Benjamin Pelletier, DBV Technologies. To better understand the mechanism of action in EPIT-induced Tregs, the study analyzed the suppressive properties of these cells in specific/ bystander conditions.
Poster Session
Session: 4210
Poster Number: 858
Session Title: Immunotherapy, Rhinoconjunctivitis
Date/Time: Monday, March 7 / 9:45 AM to 10:45 AM
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 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, 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.
