Regulatory Filings • Apr 15, 2015
Regulatory Filings
Open in ViewerOpens in native device viewer
Press Release Bagneux, France, Wednesday, April 15, 2015
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinicalstage specialty biopharmaceutical company, today announced that new clinical and nonclinical data on Viaskin® via Epicutaneous Immunotherapy (EPIT®) will be presented during 2015 European Academy of Allergy and Clinical Immunology, (EAACI) Annual Meeting in Barcelona, Spain, June 6-10, 2015. Presentations will include additional post-hoc results from the Phase 2b trial of Viaskin® Peanut in peanut allergic patients, as well as key nonclinical data on EPIT's mechanism of action.
| Title | Epicutaneous Immunotherapy (EPIT®) for peanut allergy |
|---|---|
| Date Presenter Session Name Session Type of Session Location |
June 9 - 1:30 pm to 3:00 pm Pr. Hugh A. Sampson from Kurt Hirschhorn Professor of Pediatrics, Director of the Jaffe Food Allergy Institute and Dean of Translational Biomedical Science at The Mount Sinai Medical Center in New York (USA) Beyond Oral Immunotherapy (OIT) in food allergy SYM 47 Satellite Symposium Auditorium |
| Title | Deciphering the dose-response effect of peanut Epicutaneous Immunotherapy (EPIT®) in peanut allergic subjects |
| Date Presenter Session Type of Session Location |
June 7 - 10:30 am to 12:00 pm Pr. Christophe Dupont, Head of the Pediatric-Gastroenterology Ambulatory Department at Necker Hospital, Paris, France PDS 1 New clinical data in AIT - Abstract: 1746 Poster Discussion Session Poster Discussion Zone 1 |
| Title | Epicutaneous immunotherapy to a specific allergen prevents from sensitization and anaphylaxis to further allergens: the role of regulatory T-cells |
| Date Presenter Session Name |
June 7 - 3:30 pm to 5:00 pm Dr. Lucie Mondoulet, Director of Research at DBV Technologies Control of vaccines for AIT |
The abstracts will also be published in the June 2015 supplement of the European journal of allergy and clinical immunology, Allergy.
| Session Type of Session Location |
Poster Number: 1159, Session Number: OAS 13 Oral Abstract Session Room 116 |
|---|---|
| Title | Epicutaneous immunotherapy leads to sustainable GATA-3 hypermethylation and Foxp3 hypomethylation in peanut sensitized mice |
| Date | June 8 - 3:45 pm to 5:15 pm |
| Presenter Session Name |
Dr. Lucie Mondoulet, Director of Research at DBV Technologies - Mechanisms of AIT |
| Session | Number: 1145, Session Number: PDS 19 |
| Type of Session | Poster Discussion Session |
| Location | Poster Discussion Zone 1 |
| Title | Larger homing receptor expression on Tregs suggests increased efficacy of epicutaneous compared to oral or sublingual immunotherapy for the treatment of food allergy |
| Date | June 8 - 3:45 pm to 5:15 pm |
| Presenter | Dr. Vincent Dioszeghy, Scientist at DBV Technologies |
| Session Name | Mechanisms of AIT |
| Session | Number: 1073, Session Number: PDS 19 |
| Type of Session | Poster Discussion Session |
| Location | Poster Discussion Zone 1 |
DBV will also hold a Corporate Satellite Symposium on June 7 between 5:30 pm and 7:00 pm CET entitled "Epicutaneous Immunotherapy (EPIT®), a new approach in Food Allergy". The symposium program will be uploaded on http://www.professionalabstracts.com/eaaci2015/iplanner/ and will be webcasted live. Details for this event will be posted on DBV's website, www.dbvtechnologies.com.
| Title | Epicutaneous Immunotherapy (EPIT®), a new approach in Food Allergy |
|---|---|
| Date Presenters |
June 7 - 5:30 pm to 7:00 pm - EPIT®'s Mechanism of Action and preclinical data by Dr Lucie Mondoulet - EPIT® for Food Allergy as an Alternative Pathway for Oral Tolerance Induction by Dr Christophe Dupont - EPIT® is Effective and Safe to Treat Peanut Allergy: A Multicenter Randomized Controlled Trial (VIPES) by Dr Hugh Sampson - Viaskin® Milk clinical development plan, and specific focus on Eosinophilic esophagitis |
| Type of Session Location |
(EoE) by Dr Jonathan Spergel, Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania (USA, Chief of the Allergy Section at the Children Hospital of Philadelphia Corporate Satellite Symposium Room 116 |
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, worldwide-patented technology for administering an allergen to intact skin while avoiding transfer to the blood, and thus considerably 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 from the US 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.
This press release contains forward-looking statements, including statements about the safety and efficacy of Epicutenaous Immunotherapy (EPIT) via Viaskin, including the potential to prevent sensitizations in other allergens, the potential to induce a sustained protection effect and the potential to influence the natural history of allergy. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In particular it should be noted that these data are preclinical in nature and have not been demonstrated in human subjects. 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 include 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 prospectus filed with the SEC on October 22, 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.
Nathalie Donne Director, Corporate Communication & Business Development Tel. : +33(0)1 55 42 78 72 [email protected]
Susanna Mesa VP Finance, US Investor Relations & Strategy Tel. : +1 917-346-3447 [email protected]
Marion Janic US Media Relations Rooney & Associates Tel. : +1-212-223-4017 [email protected]
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.