Full Press Release Details
Key Scientific Data Demonstrating that Epicutaneous Administration
May Reactivate Protective Immunity against Pertussis in an
experimental model published in Vaccine
PARIS, BANGKOK and GENEVA, 10 June 2015 - DBV Technologies Euronext: DBV ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage
specialty biopharmaceutical company, the University of Geneva (UNIGE) and BioNet-Asia Co. Ltd announced today the publication of key scientific data in Vaccine demonstrating the potential usefulness of the Viaskin technology to boost protective immunity against Bordetella pertussis (whooping cough). This preclinical in vivo, proof-of-concept experiment shows that a single application of DBVs
Viaskin delivering BioNet s rPT (recombinant Pertussis Toxin) alone or in combination with pertactin and filamentous hemagglutinin effectively reactivated vaccine-induced pertussis
immunity and protects against Bordetella pertussis.
DBV Technologies, UNIGE and BioNet-Asia are currently preparing a proof-of-concept Phase 1
clinical trial with a pertussis boosting vaccine using DBV s Viaskin patch technology, which allows the epicutaneous delivery of antigens without adjuvants, loaded with BioNet s
genetically-inactivated rPT. It is anticipated that this Phase 1 trial will assess the safety and immunogenicity of Viaskin rPT in 60 young adults. This trial is expected to be performed
under the supervision of Pr. Claire-Anne Siegrist of UNIGE and sponsored by DBV. The proof of concept trial is expected to start in the first quarter of 2016.
Dr. Pierre-Henri Benhamou, Chairman and CEO of DBV Technologies, said: We would like to congratulate the scientists
of the three teams for their outstanding preclinical achievement. This data demonstrates the potential efficacy of the Viaskin technology to develop a pertussis boosting vaccine without
requiring any needles or adjuvants. The growing incidence of pediatric pertussis cases advocates for the need of periodic boosters that would be facilitated by convenient and adjuvant-free vaccines. Dr. Benhamou continued,
Viaskin s epicutaneous delivery mechanism enables us to deliver optimized antigens such as BioNet s genetically-detoxified Pertussis Toxin, which could generate a better tolerated and more efficacious booster vaccine product.
Pr. Claire-Anne Siegrist, Director of the Center of Vaccinology of the University of Geneva said: It is remarkable that a
single application of Viaskin coated with 3 pertussis antigens on intact skin was capable of reactivating protective immunity against a pathogen as complex as pertussis. Should this be
observed in humans, it could tremendously facilitate the administration of this vaccine as frequent boosters are needed to maintain protection at the highest level.
Dr. Pham Hong Thai, CEO of BioNet-Asia, said: These results are consistent with the preclinical and clinical results of BioNet-Asia recombinant acellular pertussis vaccine when administered through traditional delivery. I am very happy to see this data published in the public scientific domain. We are eager to continue this exciting
collaboration with DBV and the University of Geneva to open the prospect for a needle free recombinant pertussis vaccine.
In order to mimic the
human conditions under which vaccine-induced memory cells persist while antibodies disappear, the experiment featured in Vaccine used a novel adoptive transfer murine model in which immune splenocytes were transferred to syngeneic recipients prior
to immunization and/or challenge. The data showed that a single 48-hour application of Viaskin delivering rPT, pertactin and filamentous hemagglutinin on the intact skin of primed mice
effectively triggers the reactivation of vaccine-induced memory B cells into plasma cells producing high titers of anti-PT IgG1 and IgG2a antibodies and protecting against intranasal challenge with live B. pertussis. Thus, combining the use
of an optimally immunogenic rPT and Viaskin , a novel epicutaneous delivery system, enabled reactivating protective pertussis immunity using an adjuvant-free, needleless, patient-friendly
This scientific publication, entitled Needle-free and adjuvant-free epicutaneous boosting of pertussis immunity: preclinical proof
of concept , is available online in Vaccine: http://ac.els-cdn.com/S0264410X15007628/1-s2.0-S0264410X15007628-main.pdf? tid=d811c4a6-0e97-11e5-b4b3-00000aacb35e&acdnat=1433848283_
beca05adb892343d43cc6efefb92adde
Pertussis, commonly known as whooping cough , is a very contagious respiratory illness caused by a type of bacteria called Bordetella
pertussis. Pertussis vaccination is recommended as part of routine childhood immunization. Although the incidence of pertussis has declined through the immunization of infants and young children, vaccine-induced immunity does not persist long.
This phenomenon of waning immunity was accentuated by the introduction of acellular pertussis vaccines in 1996. According to the U.S. Centers for Disease Control and Prevention (CDC), there are 16 million pertussis cases worldwide
each year, mainly in adolescents and adults who often then pass on the disease to infants who have not yet completed their pertussis immunization series, and in whom pertussis is most severe. Consequently, booster immunizations are now recommended
to adolescents and adults, especially those in contacts with young infants. A new technology - user friendly and non-invasive using a recombinant pertussis vaccine could help increase the compliance required for these booster vaccinations.
About DBV Technologies
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:
About University of Geneva
Founded in 1559 by Jean Calvin and Theodore de Beze, the University of Geneva is the second largest Haute cole in Switzerland and is amongst the top
100 best universities in the world. The institution enjoys worldwide recognition and is highly opened to the world. Every year the University welcomes around 16 000 students in its eight faculties teaching science, medecine, humanities, social and
economic sciences, law, theology, psychology and educational sciences, translation and interpreting. The University of Geneva has three missions: education, research and knowledge-sharing. The University has been a member of the League of European
Research-intensive Universities since 2002. www.unige.ch
BioNet-Asia is an independent vaccine company with a focus on technological innovation and market access. BioNet has built several strategic alliances
fostering vaccine self-reliance leading to the production and supply of billions of doses of vaccines worldwide. In its vaccine manufacturing plant in Thailand, BioNet is developing a broad pipeline of vaccines in R&D and clinical stages, such
as recombinant Pertussis, CRM197 protein carrier, Dengue and Hepatitis B vaccines. The company has successfully transferred the technology in Asia to produce Hib meningitis vaccine which is now commercialized and pre-qualified as a pentavalent
vaccine. BioNet has also filed a patent application for a new Recombinant Acellular Pertussis Vaccine that has been shown safe and highly immunogenic in a Phase I/II study. BioNet has several collaborations with first-class biopharmaceutical
companies, vaccine manufacturers and academic organizations around the globe. For additional information about the company, please visit www.bionet-asia.com
Forward Looking Statement related to DBV Technologies
This press release contains forward-looking statements, including statements about the potential safety and efficacy of Epicutenaous Immunotherapy (EPIT ). 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 Autorit des March s 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 contacts:
Nathalie Donne, Director, Corporate Communication & Business Development, T l. : +33(0)1 55 42 78 72,
Susanna Mesa, VP Finance, US Investor Relations & Strategy,
T l. : +1 917-346-3447, susanna.mesa@dbv-technologies.com
DBV Technologies US Media Contacts
Marion Janic, Rooney & Associates, T l. : +1-212-223-4017, mjanic@rooneyco.com
University of Geneva contact:
Siegrist, Director of the Center of Vaccinology. Tel: +41(22) 379 57 77. claire-anne.siegrist@unige.ch
Pham Hong Thai, CEO, BioNet-Asia Co. Ltd. Tel: +66 (2) 361 8110. Email: info@bionet-asia.com