Issue link: http://osercommunicationsgroup.uberflip.com/i/808992
Chain Drugstore Daily Monday, April 24, 2017 2 6 PHASE I TRIAL RESULTS OF VIASKIN RPT IN PERTUSSIS BOOSTER VACCINATION DBV Technologies, the Geneva University Hospitals and BioNet-Asia Co. Ltd have announced results from a Phase I trial assessing Viaskin rPT's abil- ity 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 end- point 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, limita- tions in the study design and protocol were observed. DBV, HUG and BioNet continue to review preliminary study data, and are evaluating if further devel- opment 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 immunosor- bent assay (ELISA) were not observed to be statistically significant, but serum sam- ples showed a wide distribution of human anti-PT IgG antibodies. In the placebo, Viaskin rPT 25 mcg and 50 mcg cohorts, respectively, 30 percent (n=3), 36 percent (n=9) and 40 percent (n=10) of subjects were seropositive at baseline, defined in this study as having anti-PT IgG antibod- ies 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 percent), one subject on Viaskin rPT 25 mcg (6.3 percent) and no subjects on placebo (0.0 percent) were seropositive following the second admin- istration of Viaskin rPT. DBV, HUG and BioNet continue to evaluate the immuno- genicity 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 con- duct 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 under- served 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, random- ized, double-blind, placebo-controlled safety and immunogenicity study assessed the safety of BioNet's genetical- ly-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 vaccinat- ed 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 pertus- sis 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 appli- cations of Viaskin rPT 25 mcg or place- bo. 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 wan- ing immunity, has increased since the introduction of acellular pertussis vac- cines 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 mil- lion 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 rec- ommended for adolescents and adults, but compliance is not always high. A new vaccine technology that is patient-friend- ly, 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 plat- form with broad potential applications in immunotherapy. Viaskin is based on epi- cutaneous 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 dedi- cated to safely transforming the care of food allergic patients, for whom there are no approved treatments. DBV's food allergies programs include ongoing clini- cal 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. For more information on DBV Technologies, visit 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, cardio- vascular diseases, oncology, muscu- loskeletal and sports medicine, old age medicine, genetic medicine and vaccinol- ogy. Its Center of Vaccinology, led by Professor Claire-Anne Siegrist, gained international recognition through the per- formance 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 hospi- talized patients and assure 91,000 emer- gencies, 990,000 consultations or ambu- latory care and 26,000 surgical proce- dures. 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 informa- tion can be found at www.hug-ge.ch. About BioNet-Asia BioNet-Asia offers access to vaccine and technology through biotech innova- tion and partnering networks. BioNet has built several international partner- ships 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™ and Tetanus-diphtheria-acellular Pertussis (TdaP) combination vaccine Boostagen™. 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 vac- cines to induce superior anti-PT immune response as demonstrated in compara- tive studies. Both BioNet recombinant aP and TdaP vaccines are indicated for booster use in adolescents and adults. For additional information, visit www.bionet-asia.com. EMERGENT BIOSOLUTIONS MODIFIES BOTULISM ANTITOXIN AGREEMENT Emergent BioSolutions Inc. has signed a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) to manufacture and store bulk drug sub- stance for its botulism antitoxin, BAT ® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)], valued at approximately $53 million with a five- year period of performance. This modifi- cation to the contract will enable future filling and deliveries of final drug prod- uct to the Strategic National Stockpile (SNS). BAT is indicated for the treatment of symptomatic botulism following doc- umented or suspected exposure to botu- linum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients. Emergent has been supplying BAT to the SNS under contract HHSO100200600017C, which was signed in 2006 with BARDA, within the Office of the Assistant Secretary for Preparedness and Response, in the U.S. Department of Health and Human Services. BAT is the only botulism anti- toxin licensed by the U.S. Food and Drug Administration and distributed from the Centers for Disease Control and Prevention for treating naturally occur- ring, non-infant botulism, and for admin- istration under emergency conditions.