Press Release

DBV Technologies, Geneva University Hospitals and BioNet-Asia Presented Additional Phase I Data on the Use of an Investigational Epicutaneous Patch in Boosting Pertussis Vaccination at the European Congress of Immunology

Presenting Data on the Use of an Investigational Epicutaneous Patch in Boosting Pertussis Vaccine_Page_1.jpg

PARIS, GENEVA and BANGKOK September 5, 2018 - DBV Technologies (Euronext: DBV – ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), the Geneva University Hospitals (HUG) and BioNet-Asia Co. Ltd presented new data from a Phase I study evaluating the safety and immunogenicity of boosting young adults against pertussis toxin (PT) with an investigational epicutaneous patch containing recombinant PT (Viaskin-PT). The new results, which were presented at the 5th European Congress of Immunology (ECI) in Amsterdam, Netherlands, September 2-5, 2018, by Dr. Olga Chatzis and Prof. Claire-Anne Siegrist from HUG, highlighted data from two additional cohorts showing that following skin preparation with an epidermal laser, anti-PT booster responses elicited by Viaskin-PT were comparable to those elicited by Boostrix® dTpa, an injectable approved booster vaccine. In March 2017, data from this study reported no detectable immunogenicity signal following the application of Viaskin-PT on intact skin. 

Data presented at ECI showed favorable safety and immunogenicity responses in healthy adults who received two applications of Viaskin-PT following skin preparation with an epidermal laser. No serious adverse events (SAEs) were reported. Most reported adverse events (AEs) were mild application-site reactions, and there were no AEs leading to study discontinuation. After the second application of Viaskin-PT, anti-PT IgG concentrations, which best correlate with a protective response against pertussis, were observed to be significantly higher in both Viaskin-PT cohorts (Viaskin-PT 25 µg, n=5, p

“We are excited by such strong immunogenicity results, which may be the result of the combination of a greater immunogen (recombinant PT) and a novel approach to vaccination and look forward to further exploring the use of this needle-less patch to boost immunity. We believe that the micro-pores created by the laser facilitate antigen entry in the epidermis, allowing for more antigen to be captured by lymph nodes and thus more effectively reactivate pertussis-specific memory cells. This represents an important next step in exploring the use of novel technologies for vaccination,” said Prof. Siegrist.

This Phase I proof of concept study was conducted under the supervision of Prof. Siegrist from the Clinical Research Center of HUG in collaboration with DBV Technologies and BioNet-Asia. The Company continues to evaluate these positive proof of concept results to determine potential next steps in vaccination.

Contact:

DBV Investor Relations Contact
Sara Blum Sherman
Senior Director, Investor Relations & Strategy
+1 212-271-0740
sara.sherman@dbv-technologies.com

DBV Media Contact
Raul Damas
Partner, Brunswick Group +1-212-333-3810
DBV@brunswickgroup.com

BioNet-Asia
Mr Laurent Dapremont
Director Strategic Business Development
E-mail: laurent.d@bionet-asia.com
Tel: +61 (04) 1362 0839
www.bionet-asia.com

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In-Cell-Art, the Institut Pasteur and BioNet-Asia announce the collaborative development of a dengue vaccine candidate

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Nantes – Paris – France, 19th of June, 2018 In-Cell-Art (ICA), a biotechnology company specialized in nanocarrier technologies, BioNet-Asia (BNA), an innovative vaccine developer, and the research team led by Dr. Anavaj Sakuntabhai at the Functional Genetics of Infectious Diseases Unit, Institut Pasteur Paris France, (GFMI-IP), announce today the promising development of Nanotaxi® formulated DNA vaccine to induce strong immune response against dengue virus

Under this collaboration, ICA, thanks to Nanotaxi® designed to unlock the promise of nucleic acids to treat diseases, and Dr. Sakuntabhai, with his expertise on genetic susceptibility to mosquito-borne infection, created a single component pentavalent dengue-Zika vaccine preventing antibody-dependent enhancement phenomenon. This project has been selected to be funded by the Scientific Council of the Southeast Asia-Europe Joint Funding Scheme and was praised for its vision, and expert team.

A monovalent DNA/Nanotaxi® vaccine was tested in the first instance for the evaluation of immune response against various epitopes of dengue virus.

For low-dose and mono- or multivalent vaccine design, the delivery method uses Nanotaxi®, which can deliver genetic material directly into the cytosol to increase dramatically gene expression and elicit very strong innate immune responses.

Under this collaborative effort, and with the financial supports from Agence Nationale de la Recherche - France (ANR), Thailand Center of Excellence for Life Sciences (TCELS), ICA, BNA, Institut Pasteur Cambodia, and Chulalongkorn university (Thailand), will continue the candidate development to optimize antigen compositions to induce broadly cross-reactive immune responses for Zika and dengue viruses while preventing antibody-dependent enhancement phenomenon by a patented approach.

Contacts:

In-Cell-Art

Tel: 33 (0)6 73 19 12 02

E-mail: info@incelllart.com

http://www.incellart.com

Institut Pasteur press office

Myriam Rebeyrotte - 33 (0)1 45 68 81 01

Aurélie Perthuision - 33 (0)1 45 68 89 28

presse@pasteur.fr 

BioNet-Asia 

Mr Laurent Dapremont

Director Strategic Business Development

E-mail: laurent.d@bionet-asia.com

Tel: +61 (04) 1362 0839

www.bionet-asia.com

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The HUG completes the PertADO Trial evaluating Pertagen®, a New Recombinant Pertussis Vaccine, in Adolescents in Switzerland.

The Geneva University Hospitals has conducted the PertADO Trial, the first clinical study in Europe evaluating Pertagen®, a new recombinant acellular pertussis vaccine.  BioNet’s Pertagen® is the only monovalent recombinant pertussis vaccine in the world approved in Asia for a booster indication in adolescents and adults.

GENEVA, 30 August, 2017 - The Geneva University Hospitals (HUG) and BioNet-Asia (BioNet) are announcing that results of the PertADO Trial in Switzerland show that vaccination of adolescents with Pertagen®, a new recombinant pertussis vaccine developed by BioNet, induced a higher Pertussis Toxin (PT) response 28 days after immunization than vaccination with a licensed comparator vaccine.

Sixty healthy 11-15 years old Swiss volunteers, who had been immunized with five doses of a cellular pertussis (aP) vaccine in earlier childhood, were vaccinated either with one dose of the new Pertagen recombinant aP vaccine containing genetically-detoxified PT, or one dose of a comparator licensed Tdap vaccine containing a chemically detoxified PT.  PT-antibody responses were assessed 28 days after vaccination and were found to be significantly higher in the group vaccinated with Pertagen. No safety issues were reported in any of the study participants during the follow-up period.

Professor Claire-Anne Siegrist, Director of the Center of Vaccinology of HUG, and responsible for the PertADO trial said: We are excited by the positive results showing that immune responses induced by this recombinant acellular pertussis vaccine booster are higher one month after vaccination compared to the licensed vaccine. It is the first time that this new pertussis vaccine is tested in adolescents previously immunized with five doses of conventional acellular pertussis vaccines. A monovalent recombinant pertussis vaccine, not formulated with other antigens, could represent a very interesting alternative solution to conventional Tdap vaccines when only boosting pertussis immunity is sought or needed.”

Dr. Pham Hong Thai, Chief Executive Officer of BioNet-Asia, said: “We are delighted to collaborate with the Geneva University Hospitals. This new study confirms the safety and high immunogenicity of Pertagen® which were demonstrated in previous trials in Asia.  This is a significant step towards bringing a novel acellular pertussis vaccine to Europe to address waning immunity and pertussis resurgence.”

About Geneva University Hospitals and the PertADO trial

The Geneva University Hospitals (HUG) gather eight public hospitals of Geneva. 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. 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

The PertADO Geneva Trial is a randomized double-center, and observer-blind controlled pilot Phase II study aimed at comparing the safety and immunogenicity induced by booster vaccination with acellular pertussis vaccines including chemically detoxified or recombinant PT in adolescents previously immunized with acellular pertussis vaccines.  More information at ClinicalTrials.gov Identifier: NCT02946190.

About BioNet and Pertagen®

BioNet-Asia offers access to vaccine and technology through biotech innovation and partnering networks. In 2016 BioNet received Marketing Authorization Approval from the Thai FDA for the world’s only recombinant acellular pertussis (aP) vaccines, a monovalent aP vaccine Pertagen® and a combined TdaP vaccine Boostagen™.

BioNet’s new generation pertussis vaccines are produced from a proprietary strain expressing a Pertussis Toxin genetically-detoxified (PTgen) with preserved neutralizing epitopes. 

HUG Media Contact

Nicolas de Saussure, PR Officer

 +41 (22) 372 60 06

nicolas.desaussure@hcuge.ch

BioNet Contact

Laurent Dapremont, Director Strategic Business Development

+66 (2) 361 8110

laurent.d@bionet-asia.com

www.bionet-asia.com

+66 (2) 361 8110

laurent.d@bionet-asia.com

www.bionet-asia.com

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BioNet-Asia Organized International Pertussis Symposium Celebrating its 15th Anniversary in Bangkok

Bangkok, Thailand, 21 April, 2017 – BioNet-Asia Co. Ltd organized the first International Symposium on Advances in Pertussis Immunisation in Bangkok, Thailand. The Symposium was attended by more than 300 international and Thai experts on pertussis vaccination as well as public health stakeholders, involving expert presentations and session chairing by world leaders on pertussis immunization including Prof. Stanley Plotkin (USA), Dr. Nicole Guiso (France), Prof. Terry Nolan (Australia), Prof. Keith Klugman (USA) and prominent public health leaders from Thailand including Prof. Teerapong Tantawichien and Prof. Tawee Chotpitayasundondh. The symposium coincided with BioNet’s 15th Anniversary, and the recent Marketing Approval of two of its new recombinant pertussis booster vaccines.

In his keynote presentation, Emeritus Prof. Stanley Plotkin (University of Pennsylvania, USA) discussed the reappearance of pertussis disease (whooping cough) in countries around the world and the need for new vaccine strategies and new vaccines to address this global problem. “The availability of a monovalent acellular pertussis vaccine could provide the medical community with a new way to approach pertussis immunization, especially in adolescents and pregnant women to protect their newborns” said Prof Plotkin. Western countries like Australia and USA that have been using acellular pertussis vaccines in their immunization programs since the late 90’s, have turned to recommending repeated pertussis booster vaccinations throughout life to control the spread of pertussis disease in their countries. “The protection induced by pertussis vaccines and infection is short-lived, so by keeping vaccine coverage high and revaccinating different age groups, France manages to decrease the incidence of the less than 6 months of age since 1996 “, Dr Nicole Guiso said, explaining why France still observes cycles of the disease but their intensity seems lower that those seen in other European countries. While it is mainly western countries that are reporting a rise in pertussis disease, the pertussis situation in low- and middle income countries (using whole cell pertussis vaccines) is largely unknown. “What we need are data from countries with a high uptake of whole-cell pertussis and this requires reliable surveillance systems to detect the burden of pertussis in neonatal deaths“, said Prof Keith Klugman, Director of Pneumonia at the Bill and Melinda Gates Foundation.

The Symposium was a perfect moment for BioNet to share data with the audience on two of its new pertussis vaccines, PertagenTM and BoostagenTM, produced using recombinant DNA technology, for which BioNet received Marketing Authorization Approval (MAA) from the Thai Food and Drug Administration for active booster immunization against pertussis in individuals from the age of 11 years onwards late December 2016. In her presentation Director of Clinical Development Dr. Simonetta Viviani (BioNet, Thailand) showed that in a Phase II/III clinical trial BioNet’s pertussis booster vaccines induced higher antibody responses compared to one of the currently available vaccines. “Other studies evaluating PertagenTM are planned in other countries. For example, a Phase II study is currently underway in Switzerland”, BioNet’s CEO Pham Hong Thai announced. Emeritus Prof. Piyasakol Sakolsatayadam, Minister of Public Health, Thailand, congratulated BioNet on this achievement: “I am very proud that a Thai company is making such a significant contribution to the pertussis world agenda”.

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. BioNet-Asia’s pertussis vaccine is produced from a new proprietary Bordetella pertussis strain expressing genetically detoxified Pertussis Toxin (PTgen). The unique properties of BioNet PTgen enable the vaccine to induce superior anti-PT immune response. BioNet-Asia successfully demonstrated in a Phase II/III trial that its acellular pertussis vaccine (containing PTgen and FHA), as a monovalent or in combination, could significantly boost immunity against pertussis in adolescents and adults. For additional information, please visit www.bionet-asia.com.

BioNet Contact
Laurent Dapremont, Director Strategic Business Development, BioNet-Asia Co. Ltd.
+66 (2) 361 8110
laurent.d@bionet-asia.com
www.bionet-asia.com

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BioNet Received Thai FDA Approval of the World’s Only Available Recombinant Monovalent Acellular Pertussis (aP) Vaccine

BioNet’s vaccine is the first recombinant monovalent Pertussis vaccine in the world to receive a MAA for booster indication in adolescents and adults

Bangkok, December 23rd, 2016 - BioNet-Asia announced today that its first recombinant acellular Pertussis booster vaccine containing a proprietary genetically-detoxified Pertussis Toxin (PTgen), received Marketing Authorization Approval (MAA) from the Thai Food and Drug Administration.
The vaccine is indicated in individuals from the age of 11 years onwards for active booster immunization against pertussis, a highly contagious respiratory infection caused by Bordetella pertussis. There are 16 million pertussis cases worldwide each year.

Dr Jean Petre, Chief Scientific Officer and co-founder of BioNet said: “The approval of this innovative vaccine is the fruit of ten years of research on a new generation of recombinant pertussis vaccines to overcome the limitation of conventional acellular vaccines. BioNet’s recombinant DNA technology allows the production of a genetically-detoxified Pertussis Toxin (PTgen) without altering the structure of the epitopes of the Pertussis Toxin (PT). Therefore, induced antibodies can better recognize PT epitopes which results in an increased immune response to PT, as successfully demonstrated with PTgen-containing vaccines in comparative clinical studies.


In a clinical trial, 95% of adolescents immunized with BioNet’s aP vaccine seroconverted to PT (4-fold increase of antibody titer) compared to 55% vaccinated with a leading marketed Tdap vaccine. BioNet’s recombinant vaccine also induced significantly higher anti-PT neutralizing antibody titers.


With the pertussis disease re-emerging in many countries, the medical community is advocating for pertussis control strategies and the improvement of current vaccines. Conventional Tdap vaccines provide durable protection against diphtheria and tetanus but induce short-lived pertussis immunity,” indicated Professor Stanley Plotkin, Chairman of BioNet’s Scientific Advisory Board.


The availability of such a recombinant pertussis vaccine that induce higher initial antibody levels can address an unmet medical need. Having now a monovalent acellular pertussis vaccine can provide the healthcare professionals and policy makers with a new way to approach pertussis immunization, when only boosting pertussis immunity is sought, as for example in pregnant women to protect their newborns.

BioNet’s vaccine may be considered as an alternative to combined tetanus, diphtheria and acellular pertussis vaccines in persons having received multiple and frequent tetanus and diphtheria vaccine doses.


Mr Jacques-Francois Martin, Chairman of BioNet’s Strategic Advisory Board, added: “This MAA paves the way for further registration in other countries, especially where there is a resurgence of pertussis. New clinical studies in Europe and Asia-Pacific are ongoing or under planning to further evaluate BioNet’s monovalent vaccine but also other formulations of PTgen-containing vaccines.”


In the recent years, Pertussis has been resurgent in many countries and it is a major public health concern in USA, UK and Australia.

About BioNet
BioNet-Asia offers access to vaccine and technology through Biotech innovation and partnering networks. BioNet has built international partnerships, fostering vaccine self-reliance, and leading to the supply of billions of doses of vaccines. BioNet is also developing novel technologies to produce life-saving vaccines and has been granted a patent on new strains to express PTgen for the production of recombinant pertussis vaccines.

For further information, please contact:
Mr Laurent Dapremont
Director, Strategic Business Development
E-mail: laurent.d@bionet-asia.com
Tel: +61 (04) 1362 0839
www.bionet-asia.com

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BioNet-Asia announces the formation of its Scientific Advisory Board

BioNet-Asia announces the formation of its Scientific Advisory Board

BioNet Announces the Appointment of Dr. Stanley Plotkin as Chairman of the Scientific Advisory Board


Paris, France - BioNet-Asia, an innovative clinical stage vaccine company announced the formation of BioNet Scientific Advisory Board (SAB), under the chairmanship of Emeritus Prof. Dr. Stanley Plotkin. The mission of BioNet SAB will be to provide valuable scientific advice, along with strategic guidance on its recombinant pertussis vaccine pipeline while the company is advancing rapidly with its clinical development.

The following members, well-known experts in the field of pertussis vaccinology, were appointed during BioNet first Scientific Advisory Board meeting held in Paris on March 3rd, 2016:

- Chairman of the Scientific Advisory Board - Dr. Stanley Plotkin, Emeritus Professor of Wistar Institute and University of Pennsylvania, developed the rubella vaccine now used worldwide and has worked extensively on the development and application of other vaccines including polio, rabies, varicella, rotavirus and cytomegalovirus. Dr Plotkin has held senior positions at the Epidemic Intelligence Service, U.S. Public Health and with Sanofi Pasteur. He wrote over 700 articles, and has edited several books including Vaccines, now the standard textbook in the field.

- Prof. Claire-Anne Siegrist is the Director of the Center of Vaccinology of the University Hospitals of Geneva (Switzerland), and Head of the WHO Collaborating Center for Vaccine Immunology. She is also an advisor to committees for immunization in Switzerland, the UK and WHO (Strategic Advisory Group of Experts), including for Pertussis Vaccines. Professor Siegrist has contributed to a large number of scientific publications in the field of infectious diseases and vaccine immunology.

- Dr. Nicole Guiso is the former Head of the Institut Pasteur Research Unit, Molecular Prevention and Therapy of Human Diseases, Paris (France), and Director of the French National Center of Reference for Pertussis and other bordetelloses and for toxinogenic corynebacteria. She was an advisor to the Pertussis and Diphtheria working groups of the French committee for immunization and was appointed as expert of the WHO Strategic Advisory Group of Experts working group on Pertussis Vaccines. Dr Guiso wrote over 300 articles in the field of infectious diseases.

"We are honored to welcome such eminent scientists to our advisory board to support BioNet pertussis clinical development programs," said Pham Hong Thai, the Chief Executive Officer of BioNet. Dr Stanley Plotkin commented: "I am pleased to chair the Scientific Advisory Board of BioNet and to support BioNet in developing a new generation of pertussis vaccines which has the potential to control the resurgence of pertussis in the world."

About BioNet-Asia
BioNet-Asia is a clinical-stage biotech company with a focus on technological innovation and global market access. BioNet is developing a broad pipeline of recombinant vaccines in its state-of-the-art facilities in Thailand. BioNet's first genetically-engineered pertussis vaccines are now being evaluated in Phase II/III clinical trials. The company has also built global manufacturing alliances leading to the supply of billions of doses of vaccines worldwide.


For further information, please contact:
BioNet-Asia Co., Ltd.
Mr Laurent Dapremont
Director, Strategic Business Development
E-mail: info@bionet-asia.com
www.bionet-asia.com

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