DBV Technologies, BioNet-Asia and Geneva University Hospitals Announce Phase I Trial Results of Viaskin rPT in Pertussis Booster Vaccination
(Thomson Reuters ONE) -
DBV Technologies, BioNet-Asia and Geneva University Hospitals Announce Phase I
Trial Results of Viaskin rPT in Pertussis Booster Vaccination
PARIS, BANGKOK and GENEVA March 30, 2017 - DBV Technologies (Euronext: DBV -
ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), the Geneva University Hospitals
(HUG) and BioNet-Asia Co. Ltd today announced results from a Phase I trial
assessing Viaskin rPT's ability to boost immunity against pertussis by
epicutaneously administering two doses of BioNet's recombinant pertussis toxin.
The study evaluated the safety and immunogenicity of Viaskin rPT 25 mcg (n=25)
and 50 mcg (n=25) in 60 healthy adults randomized 5:1 to each dose cohort versus
placebo (n=10). The primary endpoint of the study was the incidence of
treatment-emergent adverse events (AEs) related to the application of Viaskin
rPT, and secondary objectives assessed humoral responses compared to placebo.
After further analysis of the data, limitations in the study design and protocol
were observed. DBV, HUG and BioNet continue to review preliminary study data,
and are evaluating if further development pathways, including optimization of
Viaskin rPT, will be explored.
Mild application-site reactions were observed in all cohorts, and no serious
adverse events (SAEs) attributed to study drug were reported. After the second
application of Viaskin rPT 25 mcg and 50 mcg, measures of PT-specific antibody
responses by enzyme-linked immunosorbent assay (ELISA) were not observed to be
statistically significant, but serum samples showed a wide distribution of human
anti-PT IgG antibodies. In the placebo, Viaskin rPT 25 mcg and 50 mcg cohorts,
respectively, 30% (n=3), 36% (n=9) and 40% (n=10) of subjects were seropositive
at baseline, defined in this study as having anti-PT IgG antibodies greater than
or equal to 5 UL/mL, and thus not assessable for seropositivity analysis. In the
seronegative population at baseline, two subjects on Viaskin rPT 50 mcg (13.3%),
one subject on Viaskin rPT 25 mcg (6.3%) and no subjects on placebo (0.0%) were
seropositive following the second administration of Viaskin rPT. DBV, HUG and
BioNet continue to evaluate the immunogenicity findings observed to better
understand potential future development plans for Viaskin rPT.
"We have seen promising preclinical data showing significant immunogenicity with
Viaskin rPT. We can now take key learnings from this first clinical trial
attempt, and implement the necessary improvements needed to potentially conduct
more informative studies and improve the immunogenicity of Viaskin rPT in the
future," said Professor Claire-Anne Siegrist, Director of the Center of
Vaccinology of HUG. "The application of the novel Viaskin technology platform in
immunization enables us to explore potential areas of development for patients
that are currently being underserved by approved vaccines today."
This Phase I proof of concept study was conducted under the supervision of
Professor Claire-Anne Siegrist from the Clinical Research Center of HUG and was
sponsored by DBV Technologies.
About the Phase I Viaskin rPT Trial
This Phase I dose-escalation, randomized, double-blind, placebo-controlled
safety and immunogenicity study assessed the safety of BioNet's genetically-
detoxified recombinant pertussis toxin administered by DBV's Viaskin patches in
60 young healthy adults. Secondary endpoints assessed the subjects' humoral
responses elicited by Viaskin rPT 25 mcg and 50 mcg compared to placebo. Immune
cellular responses were also monitored as exploratory endpoints.
The trial was conducted in the Clinical Research Center of the Geneva University
Hospitals. Men and women aged 18 to 40 years who were vaccinated during
childhood against pertussis were randomized into two cohorts of 30 subjects
each. The Viaskin patches were applied for 48 hours, with a two-week interval
between applications. Four weeks after the second Viaskin application,
participants received one dose of Boostrix® dTpa vaccine to ensure the recall of
immunity against diphtheria, tetanus and the three pertussis antigens (only a
single antigen will be delivered through Viaskin rPT). All subjects were
observed after each application. Local and systemic adverse events were
monitored.
The first cohort received two applications of Viaskin rPT 25 mcg or placebo.
Following a positive DSMB review, the second patient cohort received two
applications of Viaskin rPT 50 mcg or placebo.
About Bordetella Pertussis
Pertussis, commonly known as whooping cough, is a highly contagious respiratory
illness caused by a type of bacteria known as Bordetella pertussis. Pertussis
vaccination is recommended as part of routine childhood immunization. Although
the incidence of pertussis has declined as a result of immunization of infants
and young children, vaccine-induced immunity does not persist for long. This
phenomenon, known as waning immunity, has increased since the introduction of
acellular pertussis vaccines in 1996, which tend to provide short-lived
protection against the Bordetella pertussis bacteria. 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 can infect
infants who have not yet completed their pertussis immunization. In these young
patients, pertussis can be severe and fatal.
Booster immunizations are now recommended for adolescents and adults, but
compliance is not always high. A new vaccine technology that is patient-
friendly, painless and non-invasive could help increase the compliance for
booster immunization against whooping cough.
About DBV Technologies
DBV Technologies is developing 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-of-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 A 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
About Geneva University Hospitals
The Geneva University Hospitals (HUG), reference academic institution at both
national and international level, gather eight public hospitals of Geneva. Their
centres of excellence cover hepato-biliary and pancreatic diseases,
cardiovascular diseases, oncology, musculoskeletal and sports medicine, old age
medicine, genetic medicine and vaccinology. Its Center of Vaccinology, led by
Professor Claire-Anne Siegrist, gained international recognition through the
performance of a large first-in-humans Phase I randomized clinical trial that
enrolled 115 subjects to characterize the safety and immunogenicity of the VSV-
ZEBOV Ebola vaccine candidate.
With their 10,500 employees, the HUG welcome each year 60,000 hospitalized
patients and assure 91,000 emergencies, 990,000 consultations or ambulatory care
and 26,000 surgical procedures. More than 800 physicians, 3,000 interns and 150
apprentices perform their training here. The HUG are working closely with the
Faculty of Medicine of the University of Geneva and WHO in various training and
research projects. They develop partnerships with CHUV, EPFL, CERN and other
actors from the Lemanic Health Valley. More information on: www.hug-ge.ch
About BioNet-Asia
BioNet-Asia offers access to vaccine and technology through biotech innovation
and partnering networks. BioNet has built several international partnerships
fostering vaccine self-reliance and leading to the supply of billions of doses
of vaccines worldwide. BioNet has also a broad pipeline of vaccines in R&D and
clinical stages. In December 2016 BioNet received Marketing Authorization
Approval from the Thai Food and Drug Administration for its standalone
recombinant acellular Pertussis (aP) vaccine Pertagen(TM) and Tetanus-
diphtheria-acellular Pertussis (TdaP) combination vaccine Boostagen(TM).
BioNet's new generation pertussis vaccines are produced from a proprietary
Bordetella pertussis strain expressing genetically-inactivated Pertussis Toxin
(PTgen). The unique properties of PTgen enables the vaccines to induce superior
anti-PT immune response as demonstrated in comparative studies. Both BioNet
recombinant aP and TdaP vaccines are indicated for booster use in adolescents
and adults. For additional information, please visit www.bionet-asia.com
Forward Looking Statements
This press release may contain forward-looking statements and estimates,
including statements regarding the potential safety and efficacy of Viaskin rPT
and statements reflecting management's expectations for clinical development of
Viaskin rPT. These forward-looking statements and estimates are not promises or
guarantees and involve substantial risks and uncertainties. At this stage, the
products of the Company have not been authorized for sale in any country. 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 Annual Report on Form 20-F for the year ended December
31, 2016 and future filings and reports by the Company. Existing and prospective
investors are cautioned not to place undue reliance on these forward-looking
statements and estimates, which speak only as of the date hereof. Other than as
required by applicable law, DBV Technologies undertakes no obligation to update
or revise the information contained in this Press Release.
DBV Technologies Contact
Susanna Mesa
Senior Vice President, Strategy
+1 212-271-0861
susanna.mesa(at)dbv-technologies.com
Media Contact
Andrea Fassacesia, Weber Shandwick
+1 212-445-8144
afassacesia(at)webershandwick.com
Media Contact Europe
Caroline Carmagnol, Alize RP, Relations Presse
+33 (0)6 64 18 99 59
caroline(at)alizerp.com
HUG Media Contact
Nicolas de Saussure, PR Officer
+41 (22) 372 60 06
nicolas.desaussure(at)hcuge.ch
BioNet Contact
Laurent Dapremont, Director Strategic Business Development, BioNet-Asia Co. Ltd.
+66 (2) 361 8110
laurent.d(at)bionet-asia.com
PDF Version:
http://hugin.info/156437/R/2092443/790748.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: DBV Technologies via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 30.03.2017 - 22:30 Uhr
Sprache: Deutsch
News-ID 533627
Anzahl Zeichen: 13386
contact information:
Town:
Bagneux
Kategorie:
Business News
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