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VBI Vaccines Announces Positive Top-Line Results from PROTECT, a Pivotal Phase 3 Study of Sci-B-Vac®

By June 17, 2019July 3rd, 2023No Comments
  • Both co-primary endpoints successfully met – including non-inferiority in all adults age ≥18 years, and superiority in adults age ≥ 45 years
  • Seroprotection rates four weeks post-3rd vaccination of Sci-B-Vac® vs. Engerix-B® were statistically significantly higher in key subgroup analyses of adults age ≥ 18 years
  • No safety signals observed – safety and tolerability consistent with known profile of the vaccine
  • With positive PROTECT data, pending successful completion of CONSTANT study, submissions of BLA/MAA for approval in U.S., Europe, and Canada expected to begin mid-year 2020
  • VBI to host conference call and webcast today, Monday, June 17, 2019 at 8:00 AM ET

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced positive top-line results from the randomized, double-blind, pivotal Phase 3 study, PROTECT, designed to evaluate the efficacy and safety of a 10 µg dose of Sci-B-Vac®, the company’s trivalent hepatitis B vaccine, compared with a 20 µg dose of the comparator vaccine, Engerix-B®.

The study, which enrolled a total of 1,607 adults, of which approximately 80% were age ≥ 45 years, met both of its co-primary endpoints:

Non-inferiority of seroprotection rate (SPR) of Sci-B-Vac® vs. Engerix-B® in all subjects age ≥ 18 years, 4 weeks after 3rd vaccination (at day 196)
  • The SPR in all subjects age ≥ 18 years who received Sci-B-Vac® was 91.4% compared with 76.5% for subjects who received Engerix-B®
  • The SPR in the Sci-B-Vac® cohort was statistically significantly higher than the SPR in the Engerix-B® cohort – SPR difference: 14.9%; 95% confidence interval (CI)
  • SPR is defined as the percentage of subjects achieving seroprotection, anti-HBsAg levels ≥ 10 mIU/mL
Superiority of SPR of Sci-B-Vac® vs. Engerix-B® in subjects age ≥ 45 years, 4 weeks after 3rd vaccination (at day 196)
  • The SPR in subjects age ≥ 45 years who received Sci-B-Vac® was 89.4% compared with 73.1% for subjects who received Engerix-B®
  • Superiority of Sci-B-Vac® vs. Engerix-B® was achieved in subjects age ≥ 45 years – SPR difference: 16.4%; 95% CI

Moreover, the SPR of Sci-B-Vac® compared with Engerix-B® was statistically significantly higher in all key subgroup analyses of adults age ≥ 18 years, including by age, gender, body mass index (BMI), diabetic status, and smoking status, 4 weeks after 3rd vaccination (at day 196)

  • In diabetics, the SPR in subjects who received Sci-B-Vac® was 83.3% compared with 58.3% for subjects who received Engerix-B® – SPR difference: 25.0%; 95% CI
  • In subjects with a body mass index (BMI) > 30, the SPR in subjects who received Sci-B-Vac® was 89.2% compared with 68.1% for subjects who received Engerix-B® – SPR difference: 21.1%; 95% CI

“Hepatitis B is one of the most serious global infectious disease burdens, and successful vaccination of both adults and infants is critical to controlling and, hopefully someday, eradicating the disease,” said Dr. Timo Vesikari, M.D., Ph.D., Director of Vaccine Research Center at the University of Tampere Medical School in Finland, and a principal investigator of the PROTECT and CONSTANT studies.  “These results are truly exciting and demonstrate, in a large multicenter controlled trial, the impressive efficacy of Sci-B-Vac® at a dose half that of other hepatitis B vaccines.  If approved, this vaccine could play an important role in the prevention of hepatitis B, addressing a significant unmet medical need in the adult population.”

The safety and tolerability seen in PROTECT was consistent with the known safety profile of Sci-B-Vac®, with no new safety risks identified and no safety signals observed in either study cohort.  Moreover, there were no observed clusters or unusual patterns of adverse events – the adverse events were generally consistent with characteristics of the study population.

The study did not meet the secondary objective of non-inferiority of two doses of Sci-B-Vac® (at day 168) compared with three doses of Engerix-B® (at day 196) in all subjects age ≥ 18 years, however the SPR of Sci-B-Vac® compared with Engerix-B® was statistically significantly higher at each time point on a per-visit basis:The non-inferiority analysis of two doses of Sci-B-Vac® compared with three doses of Engerix-B® in subjects age 18-45 years will be reassessed based on the complete integrated data analyses from both the PROTECT and the CONSTANT studies.  The top-line data from the CONSTANT study is expected around year-end 2019.

Successful completion of the second pivotal Phase 3 study, CONSTANT, is required for the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), the Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA), and the New Drug Submission (NDS) to Health Canada.

“We are excited to share the data from this successful head-to-head Phase 3 study, data that are extremely important milestones as we work to increase protection against hepatitis B,” said Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer.  “The positive results from PROTECT reaffirm the robust safety and efficacy data that we have for Sci-B-Vac® from previous clinical studies and from its commercial use in Israel, Hong Kong, and several other countries where it is approved or provided on a named-patient basis.”

“On behalf of everyone at VBI, I would like to extend a heartfelt thank you to the study participants and investigators.  We are extremely pleased with the top-line efficacy and safety results from PROTECT, which reinforce that Sci-B-Vac® is a potent and safe hepatitis B vaccine with the potential to provide superior protection to a broader adult population,” said Jeff Baxter, VBI’s president and CEO.  “We look forward to presenting detailed data in future publications and at medical conferences.  We expect top-line results from our second pivotal Phase 3 study, CONSTANT, around year-end 2019 – all subjects have received the final vaccination and safety follow-up visits are underway.  Pending successful completion of CONSTANT, we remain on track to submit applications for regulatory approvals in the U.S., Europe, and Canada beginning mid-year 2020.”

Conference Call and Webcast Details

VBI Vaccines will host a conference call and webcast with accompanying slides on Monday, June 17, 2019 at 8:00 AM ET.  The live webcast and slide presentation can be accessed via the Events/Presentations page in the Investors section of the company’s website, or by clicking this link:  https://edge.media-server.com/m6/p/7ryhzgu2.

A replay of the webcast will be archived on the company’s website for 90 days following the live conference call.

To listen to the live conference call, please dial:

  • Toll-free U.S. & Canada Dial-In: (866) 602-1050
  • International Dial-In: (409) 231-2052
  • Conference ID: 7639339
About PROTECT – Safety and Immunogenicity Study

PROTECT is a double-blind, two-arm, randomized, controlled study, that enrolled 1,607 subjects 18 years of age and older.  Subjects were randomized in a 1:1 ratio to receive either a three-dose course of Sci-B-Vac® 10 µg or a three-dose course of the control vaccine, Engerix-B® 20 µg.  Under the planned dosing schedule, subjects were vaccinated at months zero, one, and six.  Enrollment was stratified by age group – age 18-44, age 45-64, and age 65+.

The co-primary endpoints of the PROTECT study were:

  • To demonstrate non-inferiority of the SPR induced by Sci-B-Vac® vs. Engerix-B® four weeks after the third vaccination (at day 196) in adults age 18 years and older. Non-inferiority was defined as the lower bound of the 95% CI of the difference between SPR in the Sci-B-Vac® cohort minus the SPR in the Engerix-B® cohort being greater than -5%.
  • To demonstrate superiority of the SPR induced by Sci-B-Vac® vs. Engerix-B® four weeks after the third vaccination (at day 196) in adults age 45 and older. Statistical superiority was defined as the lower bound of the same 95% CI being greater than 0%.  Clinical superiority was defined as the lower bound of the same 95% CI being greater than 5%.

The study also included multiple secondary endpoints to evaluate the speed to seroprotection, including assessment after two doses of Sci-B-Vac® vs. three doses of Engerix-B®, and the overall safety and tolerability of Sci-B-Vac® vs. Engerix-B®.

About CONSTANT – Lot-to-Lot Consistency Study

CONSTANT is a double-blind, four-arm, randomized, controlled study.  Approximately 2,900 adult subjects, age 18-45 years, were randomized in a 1:1:1:1 ratio to receive one of four three-dose cohorts: Lot A of Sci-B-Vac® 10 µg, Lot B of Sci-B-Vac 10 µg, Lot C of Sci-B-Vac 10 µg, or the control vaccine Engerix-B® 20 µg.

The primary objective of this study will be:

  • To demonstrate lot-to-lot consistency for immune response, as measured by geometric mean concentration (GMC) of antibodies across three independent, consecutive lots of Sci-B-Vac four weeks after the third vaccination.

The secondary objective will be to evaluate safety and efficacy of Sci-B-Vac® vs. Engerix-B®.

Top-line data from the CONSTANT study is expected around year-end 2019.

 

About VBI Vaccines Inc.

VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with the only commercially-approved trivalent hepatitis B vaccine, Sci-B-Vac®, which is approved for use in Israel and 10 other countries and is currently in a Phase 3 program in the U.S., Europe, and Canada, and with an immuno-therapeutic in development for a functional cure for chronic hepatitis B. VBI’s eVLP Platform technology allows for the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. Integrating its cytomegalovirus (CMV) expertise with the eVLP platform technology, VBI’s lead eVLP program candidates include a prophylactic CMV vaccine candidate and a therapeutic glioblastoma (GBM) vaccine immunotherapeutic candidate. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.

Cautionary Statement on Forward-looking Information

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The company cautions that such statements involve risks and uncertainties that may materially affect the company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital, and to obtain such funding on commercially reasonable terms; the company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the company, is set forth in the Company’s filings with the Securities and Exchange Commission and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2019, and filed with the Canadian security authorities at sedar.com on February 25, 2019, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

VBI Contact

Nicole Anderson
Associate, Corporate Communications
Phone: (617) 830-3031 x124
Email: info@vbivaccines.com

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Chief Business Officer
Email: IR@vbivaccines.com

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Burns McClellan, Inc.
Robert Flamm, Ph.D.
Phone: (212) 213-0006
Email: rflamm@burnsmc.com

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Pierre Van Damme, M.D., Ph.D.

Pierre Van Damme is full professor at the University of Antwerp, Faculty of Medicine and Health Sciences. He chairs the Vaccine & Infectious Disease Institute (VAXINFECTIO, University of Antwerp); VAXINFECTIO is a consortium of three research units within the university. In 2000, he was appointed Professor at the Faculty of Medicine and Health Sciences, University of Antwerp – he teaches infectious diseases and vaccinology in the Faculty of Medicine and Health Sciences as well as in the Faculty of Pharmacy and Biomedical Sciences, and within master programs in vaccinology at the University of Florence and Siena.

Professor Van Damme has authored more than 350 peer-reviewed papers and is on the editorial board of several scientific journals that focus on the study of vaccines and vaccine-preventable infectious diseases. Professor Van Damme was awarded with the Research Award of the University of Antwerp, and in 2000 with the Belgian Social Medicine Award ‘Jean Van Beneden’ for his work on the introduction of universal hepatitis B immunization programs. In May 2014, he was awarded with the prestigious Bill Marshall award of the ESPID society.

John D. Grabenstein, Ph.D., R.Ph.

Dr. Grabenstein is a global vaccinologist, pharmacist, epidemiologist, and public-health leader specializing in adult vaccines, implementation, and vaccine history. Currently, Dr. Grabenstein is president of consulting service Vaccine Dynamics SP, and is also Associate Director of Scientific Communications for the Immunization Action Coalition (IAC), a non-profit organization working to increase immunization rates and prevent disease by creating and distributing educational materials for health professionals and the public. Previously, he spent over 13 years at Merck Vaccines, most recently serving as Global Executive Director of Medical Affairs until his retirement in late 2019. Before joining Merck, Dr. Grabenstein served for 27 years in the U.S. Army Medical Department, achieving the rank of Colonel. From 1999 to 2006, he directed the scientific elements of the U.S. Department of Defense (DoD) anthrax and smallpox vaccination programs. As Director, Military Vaccine Agency, he was responsible for science, communication, education, and safety surveillance of military immunizations for 2.6 million U.S. Army, Navy, Marine Corps, Air Force, and Coast Guard personnel deployed globally.

Damian Braga

Director, Chair of Commercial Advisory Board

Dr. Bresnitz is an accomplished public health physician bringing over four decades of experience in academia, government public health, and the pharmaceutical industry, with a focus on the development of vaccines and implementation of vaccine policy. Dr. Bresnitz is currently serving as Medical Advisor to the New Jersey State Department of Health’s COVID-19 Response and was formerly the New Jersey State Epidemiologist with successive positions as Assistant, Senior Assistant, and Deputy Commissioner of Health for Public Health Services from 1999-2008. In 2020, Dr. Bresnitz retired from a 12-year career at Merck & Co., Inc., where he served as Medical Director, Global Medical Affairs and Policy, as well as Executive Director, Adult Vaccines, Global Vaccine Medical Affairs. As Executive Director, Dr. Bresnitz was responsible for the development and execution of medical affairs strategies for the adult vaccine portfolio that included pneumococcal, herpes zoster, and the hepatitis A and B vaccines, Vaqta and Recombivax HB, respectively. Prior to his service in the New Jersey State Government, Dr. Bresnitz was Chairman of the Department of Community and Preventive Medicine at Drexel University’s School of Medicine.

Adam Finn, M.D., Ph.D.

Adam Finn is Professor of Paediatrics at the University of Bristol, UK. He studied Medical Sciences at Cambridge University and then moved to University of Oxford Medical School to complete his clinical degree in 1983. After qualifying he did training jobs in paediatrics in Sheffield, Bristol and Guy’s Hospital London before taking up a fellowship in Infectious Diseases at the Children’s Hospital of Philadelphia in 1987. He completed his academic training as Lecturer in Immunology at the Institute of Child Health, Great Ormond St, London where he wrote his Ph.D.

In 1992, he took up a senior lecturer position at the University of Sheffield, UK. Over the following 9 years he established both clinical and laboratory research groups there, focussing on mucosal immune responses to paediatric conjugate vaccines and the pathogenesis of upper and lower respiratory tract pneumococcal infection. In 2001, he moved to Bristol where he is now Theme Leader for Infection & Immunity, University of Bristol and Clinical Research Lead – Children, Genetics, Haematology, Reproductive Health and Childbirth for the NIHR Clinical Research Network: West of England. He is also a senior clinician in the paediatric immunology and infectious diseases clinical service at Bristol Royal Hospital for Children and the South West region and heads the Bristol Children’s Vaccine Centre. In addition, he became Chairman of the WHO European Technical Advisory Group of Experts (ETAGE) on Immunization in December 2011 and ex officio member of the WHO Strategic Advisory Group of Experts, Member of the UK Department of Health Joint Committee on Vaccination and Immunisation (JCVI) since October 2014. In 2015, he was elected President of the European Society for Paediatric Infectious Diseases (ESPID).

His research interests are elucidation of the nature of naturally acquired mucosal immunity to pneumococcus, meningococcus and other respiratory bacteria, the determinants of bacterial transmission and vaccine indirect effects and development of tools to assess human immune responses to candidate vaccine antigens. He also leads and supports numerous clinical trials of drugs and medicines in children.

Peter A. Patriarca, M.D.

Peter A. Patriarca, M.D., is the Principal of Immuno-Vax, LLC, and a senior affiliate consultant with the Biologics Consulting Group, Inc. (Alexandria, Virginia), and has provided technical and regulatory consulting services for all phases of vaccine and drug development for the past 13 years. Prior to consulting, Dr. Patriarca was Corporate Head and Vice President, Worldwide Regulatory Affairs and Pharmacovigilance at MedImmune, Inc. (2001-2005) and also served as Medical Officer in the U.S. Public Health Service at the Centers for Disease Control and Prevention (1980-1992) and the US Food and Drug Administration (1993-2001). At FDA, Dr. Patriarca served, among other positions, as Director of the Division of Viral Products in the Office of Vaccines Research and Review (OVRR), CBER. In that capacity, he oversaw research and review activities of more than 100 scientific staff in eight laboratories, and was intimately involved with regulatory decisions and policy affecting vaccine development and licensure. While at CDC, Dr. Patriarca was assigned to the National Immunization Program, where, among other positions, he served as the Chief Medical Epidemiologist in the Influenza Division and the first head of CDC’s program in support of the Global Poliomyelitis Eradication Initiative. He has authored more than 100 peer-review publications and has served on multiple scientific advisory bodies for CDC, WHO, the Bill and Melinda Gates Foundation, the American Academy of Pediatrics, the National Academy of Sciences, and numerous pharmaceutical companies.

Michel De Wilde, Ph.D.

Director, Chair of Scientific and Clinical Advisory Boards

Michel De Wilde, Ph.D., was Senior Vice President, Research & Development, at Sanofi Pasteur, the human vaccines division of Sanofi from 2001 until June 2013. In this position, he was responsible for managing approximately 1,500 employees and a broad portfolio of approximately 20 development projects.

Prior to joining Sanofi Pasteur in January 2000, Dr. De Wilde was at SmithKline Beecham Biologicals (now GSK Vaccines) in Rixensart, Belgium. Dr. De Wilde joined the group in 1978 as a research scientist upon formation of a unit focusing on the application of recombinant DNA technology to vaccine development. He subsequently held positions of increasing responsibility and, as Vice President, Research & Development at Sanofi Pasteur, headed a team of approximately 400 specialists, active in all aspects of preclinical vaccine development.

Dr. De Wilde a member of a number of Scientific Advisory Boards, including COVAX Independent Product Group and other COVID related advisory bodies.

Dr. De Wilde received his degree in Chemistry from the Free University of Brussels in 1971, followed by a Ph.D. in Biochemistry in 1976. He carried out postdoctoral work at the University of Wisconsin, Madison (U.S.) and the University of Ghent (Belgium). Dr. De Wilde authored over 50 publications during the early part of his career.

Dr. De Wilde is also a Senior Scientific Advisor on all three of VBI’s Scientific and Clinical Advisory Boards.

Daniel Shouval, M.D.

Dr. Daniel Shouval is a graduate of the Hadassah–Hebrew University Medical School in Jerusalem, Israel. After completing his residency in Internal Medicine at Hadassah, Dr. Shouval was trained in Cell Biology, Immunology, and Molecular Biology at the Liver Research Center at Albert Einstein College of Medicine in New York, and the Massachusetts General Hospital in Boston. His main research interests and publications include Biology of and immune response to hepatitis B and A virus infection and liver tumors . Dr Shouval has been involved in the development of several vaccines and anti-viral agents against viral hepatitis B ,C and A. In recent years his main efforts are focused on developing a third generation Pre-S/S hepatitis B vaccine; intervention in persistent hepatitis B infection, prevention of hepatitis B infection in liver transplant recipients, adoptive transfer of immunity against hepatitis B and pre/post-exposure prophylaxis against hepatitis A. Dr. Shouval is the author/co-author of >250 publications, Editorials in leading Hepatology journals and chapters in books.

Dr. Shouval is Professor Emeritus of Medicine at the Hebrew University and Hadassah Medical School in Jerusalem and former Dean of the Faculty of Medicine. He was a visiting Professor at the Albert Einstein College of Medicine in New York and had similar positions at the Harvard Medical School and Massachusetts General Hospital in Boston, USA (1987-88) and at the Liver Transplantation Center , Paul Brousse hospital, the University of Paris, France (1998-99). Prof. Shouval served as President of the European Association for the Study of the Liver in 1996/7; he is the recipient of EASL’s Recognition Award and nomination to EASL’s hall of fame and recently served as EASL honorary president(2016) . Between 1998-2002 he was Chairman of the Educational Committee of EASL. He served in a number of editorial boards in hepatology journals and was the founding editor of the FOCUS section in the Journal of Hepatology. Dr Shouval is a standing adviser to the European Viral Hepatitis Prevention Board and the World Health Organization.

Bruce Smith, Ph.D.

Dr. Bruce Smith is a Professor in the Department of Mathematics and Statistics at Dalhousie University, and a member of the Canadian Center for Vaccinology. Bruce received a Ph.D. in Biostatistics from the University of California, Berkeley, in 1988, and has been at Dalhousie since that time, where he has served as Director of the Division of Statistics and Chair of the Department of Mathematics and Statistics. His research interests are in applied statistics and time series analysis, with applications to vaccinology, the estimation of quantitative genetic traits, and environmetrics. He is President Elect of the Statistical Society of Canada.

Stefan Thoelen, M.D.

Dr. Thoelen has been a vaccinology consultant since 2008. Prior to consulting, Dr. Thoelen accrued over 20 years of experience as the Global Head of Clinical Development and Operations Vaccines for Sanofi Pasteur, and also as the Head of Clinical Development, Operations and Medical Affairs in Latin America for GlaxoSmithKline.

Nadia G. Tornieporth, M.D.

Dr. Tornieporth is a physician with extensive leadership experience and technical expertise in the clinical development of vaccines. She is Professor of Clinical Research and Pharmacovigilance at the University of Applied Sciences and Arts in Hannover, Germany. Previously, Dr. Tornieporth served as Vice President and Head of Global Clinical Research and Development at Sanofi Pasteur where she oversaw all aspects of clinical development from First-in-Man to successful registration. Prior to her time at Sanofi, she was Vice President of Clinical Development, Prophylactic Vaccines at GlaxoSmithKline Biologicals. Over the course of her career, Dr. Tornieporth contributed to the successful licensure of more than 20 vaccines. She has served as an advisor to the World Health Organization, USAID, the Wellcome Trust, and the European Forum for Good Clinical Practice, among others. She contributes to several vaccine development programs as member of Independent Data Monitoring Committees and Scientific Advisory Boards, and currently serves as acting Head, Clinical Development, for the Coalition of Epidemic Preparedness Innovations (CEPI). Earlier in her career, Dr. Tornieporth held international research and teaching positions at Weill Cornell Medical College and Ludwig-Maximilian University. Dr. Tornieporth received her M.D. from Ludwig-Maximilian University in Munich, Germany and her Diploma in Tropical Medicine and Hygiene from the London School of Hygiene and Tropical Medicine. She holds clinical patents for the RTS,S malaria and dengue vaccines and has co-authored more than 60 peer-reviewed publications in infectious diseases and vaccine development.

Michael D. Decker, M.D., M.P.H.

Current Adjunct Professor of Preventive Medicine at Vanderbilt University Medical Center, Dr. Decker is a well-published expert on vaccines, preventive medicine, and public health policy. In 2016, Dr. Decker retired from Sanofi Pasteur after more than 15 years, where he was Vice President and Global Medical Expert from 2013-2016 and Vice President, Scientific and Medical Affairs, and Chief Medical Officer, Sanofi Pasteur U.S., from 2000-2012. From 1984-2000, Dr. Decker was a Professor of Preventive Medicine and Medicine (Infectious Diseases) at Vanderbilt University School of Medicine. He has also previously served as a Medical Officer in the U.S. Public Health Service at the Centers for Disease Control and Prevention (CDC), as Editor-in-Chief of the journal Infection Control and Hospital Epidemiology from 1993 to 2001, and as Co-Editor of the International Journal of Health Governance from 2016 to 2020.

Denis R. Burger, Ph.D.

Current Vice Chairman and Chief Science Officer of CytoDyn Inc., and lead independent director of Aptose Bioscience Inc., Dr. Burger co-founded Trinity Biotech plc, and is currently its lead independent director. Previously, Dr. Burger was the Chairman and Chief Executive Officer of AVI Biopharma Inc. (now Sarepta Therapeutics), and co-founder of Epitope Inc. (now Orasure Technologies), as well as a professor in the Department of Microbiology and Immunology and Surgery (Surgical Oncology) at the Oregon Health and Sciences University in Portland.

Michael Lim, M.D.

Dr. Michael Lim is a Professor of Neurosurgery, Oncology, Otolaryngology, and Radiation Oncology at Johns Hopkins. Dr. Lim obtained his MD from the Johns Hopkins University School of Medicine. He then completed his residency in Neurosurgery at Stanford University Hospital. Dr. Lim’s surgical interest is in both benign and malignant brain tumors, with a particular interest in gliomas (including ependymoma), meningioma, pituitary tumors and skull base tumors. He has extensive experience in new and innovative neurosurgical techniques including image guided surgery, microsurgery, minimally invasive procedures and endoscopic surgery. Dr. Lim is also the Director of the Brain Tumor Immunotherapy Program at Johns Hopkins. His primary research interest is developing immune-based therapies against brain tumors. His research laboratory is focused on understanding the mechanisms of immune evasion by primary brain tumors. Findings from Dr. Lim’s laboratory are directed towards translation to novel therapies against brain tumors. In addition to running a laboratory, he also directs the immunotherapy clinical trials program at Johns Hopkins. Dr. Lim currently serves as the principal investigator of several large brain tumor immunotherapy clinical trials based on findings from his laboratory.

Allen Waziri, M.D.

Dr. Waziri is currently CEO and Co-Founder of iCE Neurosystems, a privately held medical device company. He was previously Director of the Brain Tumor Program at the Inova Neuroscience Institute. Prior to taking the position at Inova he was Assistant Professor of Neurological Surgery and faculty in the Cancer Biology program at the University of Colorado. His research has focused on the study of mechanisms involved with the suppression of cellular immunity by myeloid-lineage cells in human glioblastoma, identified through the analysis of fresh human tissues. Dr. Waziri has served as Principal Investigator for a range of early- to late-phase clinical trials in primary and secondary glioblastoma, including several investigator-initiated first-in-human pilot studies encompassing serial immunomonitoring in patients to explore restitution of cellular immune function by targeting myeloid-derived immunosuppression.

Patrick Yung Wen, M.D.

Dr. Wen is Professor of Neurology at Harvard Medical School, Director of the Center For Neuro-Oncology at Dana-Farber Cancer Institute, Co-PI of the Adult Brain Tumor Consortium, Steering Committee Member of the Response Assessment in Neuro-Oncology (RANO) Working Group, and President of the Society of Neuro-Oncology. He was previously the Editor-In-Chief of Neuro-Oncology. His research is focused on novel treatments of brain tumors and optimizing clinical trial design, endpoints, and response assessment.

Robert Pass, M.D.

Dr. Robert Pass is a Professor of Pediatrics at the University of Alabama at Birmingham where he led clinical and epidemiological studies of maternal and congenital cytomegalovirus CMV infection for a number of years. Early in his research career Dr. Pass became convinced that the most important goal of CMV research should be prevention of congenital infection. He focused his research on understanding how CMV is spread, risk factors for CMV infection during pregnancy, and sources of maternal infection. In the 1990s, Dr. Pass conducted a number of industry supported clinical trials of a CMV glycoprotein B vaccine, which led to an investigator initiated, National Institutes of Health sponsored clinical trial of a CMV glycoprotein B vaccine. This work provided the first evidence of vaccine efficacy for prevention of maternal and congenital CMV infection.

Stanley Plotkin, M.D.

Dr. Stanley A. Plotkin is Emeritus Professor of the University of Pennsylvania, and Adjunct Professor of the Johns Hopkins University. Until 1991, he was Professor of Pediatrics and Microbiology at the University of Pennsylvania, Professor of Virology at the Wistar Institute, and at the same time, Director of Infectious Diseases and Senior Physician at the Children’s Hospital of Philadelphia. In 1991, Dr. Plotkin left the University to join the vaccine manufacturer, Pasteur-Mérieux-Connaught, where for seven years he was Medical and Scientific Director, based at Marnes-la-Coquette, now known as Sanofi Pasteur.

Dr. Plotkin has developed several pediatric vaccines including the rubella vaccine now in standard use throughout the world and a recently licensed pentavalent rotavirus vaccine. He has also been involved in other vaccine development programs including anthrax, oral polio, rabies, varicella, and cytomegalovirus.

Dr. Plotkin’s bibliography includes nearly 700 articles and he has edited several books including the standard textbook on vaccines, now in its 5th edition. He is a consultant to vaccine manufacturers, biotechnology companies, and non-profit research organizations as principal of Vaxconsult, LLC.

Dr. Plotkin attended New York University, where he received a B.A. degree, and then the State University of New York Medical School in Brooklyn, where he received an M.D. degree in 1956.

Nadia G. Tornieporth, M.D.

Dr. Tornieporth is a physician with extensive leadership experience and technical expertise in the clinical development of vaccines. She is Professor of Clinical Research and Pharmacovigilance at the University of Applied Sciences and Arts in Hannover, Germany. Previously, Dr. Tornieporth served as Vice President and Head of Global Clinical Research and Development at Sanofi Pasteur where she oversaw all aspects of clinical development from First-in-Man to successful registration. Prior to her time at Sanofi, she was Vice President of Clinical Development, Prophylactic Vaccines at GlaxoSmithKline Biologicals. Over the course of her career, Dr. Tornieporth contributed to the successful licensure of more than 20 vaccines. She has served as an advisor to the World Health Organization, USAID, the Wellcome Trust, and the European Forum for Good Clinical Practice, among others. She contributes to several vaccine development programs as member of Independent Data Monitoring Committees and Scientific Advisory Boards, and currently serves as acting Head, Clinical Development, for the Coalition of Epidemic Preparedness Innovations (CEPI). Earlier in her career, Dr. Tornieporth held international research and teaching positions at Weill Cornell Medical College and Ludwig-Maximilian University. Dr. Tornieporth received her M.D. from Ludwig-Maximilian University in Munich, Germany and her Diploma in Tropical Medicine and Hygiene from the London School of Hygiene and Tropical Medicine. She holds clinical patents for the RTS,S malaria and dengue vaccines and has co-authored more than 60 peer-reviewed publications in infectious diseases and vaccine development.

Vaughn Himes, Ph.D.

Director

Dr. Himes brings over three decades of industry experience to VBI’s Board, including nearly 15 years at Seagen, where he is currently the Chief Technology Officer and leads the manufacturing, supply chain, process sciences, and quality functions. During his tenure at Seagen, Dr. Himes has helped lead the transition from a research and development-stage company through the successful commercial launch of its first four commercially marketed products, and has played key roles in Seagen’s M&A activity leading to the recent announcement of Pfizer’s intent to acquire the company. Prior to joining Seagen in 2009, Dr. Himes spent 20 years in leadership roles overseeing CMC, manufacturing, supply chain and logistics, quality control, process development, and product development operations at ZymoGenetics Corporation (acquired by Bristol Myers Squibb), Corixa Corporation (acquired by GlaxoSmithKline), Targeted Genetics Corporation, Genovo Inc., and Wyeth-Lederle Vaccines (later acquired by Pfizer). Dr. Himes holds a Ph.D. in Chemical Engineering from the University of Minnesota, and a B.A in Chemistry from Pomona College. He also serves as a director on the Board for Achieve Life Sciences, Inc.

Christopher McNulty

Chief Financial Officer and Head of Business Development

Mr. McNulty joined VBI in 2018 after two decades of financial and business development experience across the pharmaceutical, biotechnology, and medical device industries. Prior to joining VBI, he served as Chief Financial Officer and Senior Vice President, Business Development and Investor Relations, of Invivo Therapeutics. He also served as the Senior Director of Business Development for Repligen Corporation, where he spearheaded the acquisition of Novozymes Biopharma Sweden in 2011. Other prior management positions include Director, Corporate Development at Seventh Sense Biosystems, and Associate Director, Business Development at Genzyme Corporation. Mr. McNulty holds B.S. and M.Eng. degrees from the Massachusetts Institute of Technology, as well as an M.B.A. from Harvard Business School.

Steven Gillis, Ph.D.

Chairman of the Board

Steven Gillis, Ph.D., has been a Managing Director of ARCH Venture Partners since 2006 and joined the firm in 2005. Dr. Gillis is focused on the evaluation of new life science technologies and also on the development and growth of ARCH’s biotechnology portfolio companies. He is a director of Takeda Pharmaceutical Co. Ltd. (TAK), Homology Medicines, Inc. (FIXX), and also serves as Chairman of Codiak Biosciences (CDAK). Dr. Gillis represents ARCH as a managing director and serves as Chairman of a number of ARCH’s private, biotechnology portfolio companies.

Dr. Gillis was a founder and director of Corixa Corporation and served as CEO from its inception and as its Chairman from 1999 until its acquisition in 2005 by GlaxoSmithKline. Prior to Corixa, Dr. Gillis was a founder and director of Immunex Corp. From 1981 until his departure in 1994, Dr. Gillis served as Immunex’s Director of Research and Development, Chief Scientific Officer, and as CEO of Immunex’s R&D subsidiary. Dr. Gillis was interim CEO of Immunex Corp. following its majority purchase by American Cyanamid Company and remained a member of the board until 1997. Amgen, Inc. acquired Immunex in 2002.

Dr. Gillis is an immunologist by training with over 300 peer-reviewed publications in the areas of molecular and tumor immunology. He is credited as being a pioneer in the field of cytokines and cytokine receptors, directing the development of multiple marketed products including Leukine, (GM-CSF), Prokine (IL-2) and Enbrel (soluble TNF receptor-Fc fusion protein) as well as the regulatory approval of Bexxar (radiolabeled anti-CD20). Dr. Gillis received a B.A. from Williams College and a Ph.D. from Dartmouth College.

David E. Anderson, Ph.D.

Chief Scientific Officer

A dynamic and well-published immunologist with broad expertise in the areas of vaccine development, autoimmunity and tumor immunology, Dr. Anderson joined VBI full time in 2009 from Harvard Medical School, where he held a position as Assistant Professor. As a co-founder and Chief Scientific Officer of VBI, Dr. Anderson is an inventor of much of the Company’s intellectual property and actively manages its ongoing expansion. Dr. Anderson holds a Ph.D. from Harvard University and a B.S. from the University of California at Davis.

Nell Beattie

Chief Financial Officer and Head of Corporate Development

Ms. Beattie joined VBI in 2015 after completing her M.B.A at the Tuck School of Business at Dartmouth College. Prior to receiving her M.B.A., she was a consultant at Artisan Healthcare Consulting, where she worked with pharmaceutical and biotechnology companies to develop financial and strategic analyses, as well as provided guidance and support for corporate and business development efforts. Ms. Beattie also holds a B.A. from Dartmouth College.

Adam Buckley

Senior Vice President, Business Development

In 2001, Mr. Buckley helped establish VBI. His efforts included attracting seed capital to VBI, developing its first business plan, protecting intellectual property and structuring the company. He had an active role in the company’s Series A financing, raising $35.7 million (U.S.), and has led several key technology acquisitions for the company. Mr. Buckley obtained his M.B.A. and Bachelor of Science in Biology and Psychology at McMaster University in Canada. Prior to joining VBI, he built experience in project management and corporate development at Riverview Hospital in Coquitlam, British Columbia, and at the Children’s Hospital of Eastern Ontario in Ottawa, Ontario.

Francisco Diaz-Mitoma, M.D., Ph.D.

Chief Medical Officer

Dr. Diaz-Mitoma is a renowned medical scientist and professor who most recently served as a professor of the Northern Ontario School of Medicine (“NOSM”). While in this position, Dr. Diaz-Mitoma was Vice President of Research at Health Sciences North and founder of the Advanced Medical Research Institute of Canada (“AMRIC”) and served as its Chief Executive Officer and Chief Scientist. AMRIC is focused on translational medical and vaccine development research. Prior to joining the faculty at the NOSM, Dr. Diaz-Mitoma was a professor of Pediatrics, Pathology, Laboratory Medicine, and Microbiology at the University of Ottawa. While in this position, he founded the Vaccine and Infectious Disease Centre at the Children’s Hospital of Eastern Ontario (“CHEO”), a pediatric health and research center. Dr. Diaz-Mitoma received his medical degree from the University of Guadalajara, completed fellowship training in Infectious Diseases at the University of Manitoba, and earned a Ph.D. in Virology from the University of Alberta.

John Dillman

Chief Commercial Officer

Mr. Dillman joined VBI in 2022 after two years as VBI’s Commercial Lead at Syneos Health, VBI’s partner for the U.S. commercialization of PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], and nearly two decades of commercial sales and marketing leadership experience at Sanofi Pasteur, the human vaccines business of the Sanofi Group. His most recent role was Vice President of Sales, where he was responsible for the direction and oversight of the sales force, marketing and sales training, and telesales organization, with full P&L responsibility delivering over $3 billion of sales annually. While at Sanofi Pasteur, Mr. Dillman was also responsible for all segment, consumer, and digital marketing activities, and spent three years as the General Manager of VaxServe, a Sanofi Pasteur company and a leading specialty distributor of vaccines. Mr. Dillman holds a Bachelor of Business Administration degree from Bridgewater State University, and an M.B.A. with a focus in marketing from West Virginia University.

Athena Kartsaklis

Senior Vice President, Finance

Ms. Kartsaklis is a U.S. Certified Public Accountant and Canadian Chartered Professional Accountant who joined VBI in 2017 with over 25 years of financial management experience, including financial reporting, budgeting and forecasting, auditing, and the management of internal controls. Prior to joining VBI, Ms. Kartsaklis held financial leadership roles at SkyWave Mobile Communications Inc. and Alterna Savings. From 2000 to 2012, Ms. Kartsaklis was a Partner at Deloitte, Hadjipavlou, Sofianos & Cambanis S.A., Athens, Greece (Member of Deloitte & Touche International), having worked there since 1992. Ms. Kartsaklis received a Bachelor of Commerce degree from Dalhousie University in Halifax, Nova Scotia.

Avi Mazaltov

Global Head of Manufacturing and SciVac General Manager

Mr. Mazaltov is an operations executive with broad experience across industries in defining, managing, and optimizing manufacturing and supply chain activities. Mr. Mazaltov joined VBI in 2017 from Omrix Biopharmaceuticals (a Johnson & Johnson company). At Omrix, Mr. Mazaltov was responsible for Biosurgery operations in Israel and was a member of the Biosurgery leadership team. Prior to joining Omrix, Mr. Mazaltov led the Operations and Infrastructures division of Alvarion Technologies. Prior to Alvarion, Mr. Mazaltov held various high-ranking operational roles at Teva Pharmaceuticals, including Director, Global Manufacturing and Plant Manager, Kfar Saba, where he managed a production facility with 1,000+ employees. Mr. Mazaltov holds a B.Sc. in Production Management from Ben Gurion University of the Negev, Israel.

Jeff Baxter

President and CEO

Mr. Baxter joined VBI in September of 2009. Previously, he was a managing partner for the venture capital firm, The Column Group. Until July of 2006, Mr. Baxter was SVP, R&D Finance and Operations, of GlaxoSmithKline (GSK). In his 19 years of pharma experience, he has held line management roles in commercial, manufacturing and IT and the office of the CEO. His most recent position in R&D included responsibility for finance, pipeline resource planning and allocation, business development deal structuring and SROne (GSK’s in-house $125m venture capital fund). He also chaired GSK’s R&D Operating Board. Prior to GSK, he worked at Unilever. Mr. Baxter was educated at Thames Valley University and is a Fellow of the Chartered Institute of Management Accountants (FCMA).

Misha Nossov

Senior Vice President, Global Commercial Supply Strategy & Head of Europe

Mr. Nossov joined VBI in 2010 after completing the Master in Biotechnology (MBiotech) program at the University of Toronto. Prior to his current role as Senior Vice President, Global Commercial Supply Strategy & Head of Europe, Mr. Nossov held operational roles of increasing responsibility, including as Head of the VBI Research and Development site in Ottawa, Canada, ensuring execution of the company’s research strategy. Mr. Nossov holds a B.Sc. Honours in Biochemistry from McGill University.

Damian Braga

Director

Damian Braga was Senior Vice President, Global Commercial Operations & President, U.S. and the Americas at Sanofi Pasteur, the human vaccines division of Sanofi, until his retirement in 2015. In these roles, he was responsible for leading the development and execution of the commercial strategy for all existing and late-stage products for Sanofi Pasteur’s Global Vaccine Business.

Mr. Braga brings three decades of vaccine experience from his tenure at Sanofi Pasteur, serving as Senior Vice President, Global Commercial Operations, from 2010 to 2015, as President, U.S. and the Americas, from 2008 to 2015, and as President, U.S., from 2002-2007. During this time, Mr. Braga was responsible for growing U.S. vaccine revenues from $766 million in 2001 to over $3.1 billion in 2015. He was also responsible for successfully launching both a high-dose and quadrivalent flu vaccine, generating over $1.5 billion in global flu vaccine annual revenue. Prior to assuming responsibility as the most senior company executive in the Americas, Mr. Braga held a number of other roles within Sanofi Pasteur, including Chief Financial Officer for the U.S. Business Unit.

Since retirement from Sanofi Pasteur in 2015, Mr. Braga founded DAB Consulting Services, a pharmaceutical commercialization consulting firm, and since 2017, he has served as an advisor for VaxCare, a company that provides vaccination solutions for physicians, healthcare systems, employers, and school systems.

Mr. Braga is also the Chairperson of VBI’s Commercial Advisory Board.

Joanne Cordeiro

Director

Ms. Cordeiro most recently served as Chief Human Resources Officer and Executive Vice President of Human Resources at Shire PLC, where she served as the strategic partner and advisor to the CEO, Executive Team, and Board of Directors on matters of organizational vision, human capital strategies, total rewards, ethics, and cultural topics with a focus on shareholder value. Ms. Cordeiro was also a member of the Shire Steering Committee responsible for leading the strategic direction and integration for mergers, acquisitions, and divestitures. Prior to joining Shire in 2011, she was Head of Human Resources for Covansys Corporation (a CSC Company), Clam/Availant, and Elliason Group, and served in various human resources management roles at Teradyne Inc., Avid Technology, Inc., and Sybase Inc. (an SAP company).

Ms. Cordeiro received her Bachelor of Science in Business Administration from Northeastern University.

Michel De Wilde, Ph.D.

Director

Michel De Wilde, Ph.D., was Senior Vice President, Research & Development, at Sanofi Pasteur, the human vaccines division of Sanofi from 2001 until June 2013. In this position, he was responsible for managing approximately 1,500 employees and a broad portfolio of approximately 20 development projects.

Prior to joining Sanofi Pasteur in January 2000, Dr. De Wilde was at SmithKline Beecham Biologicals (now GSK Vaccines) in Rixensart, Belgium. Dr. De Wilde joined the group in 1978 as a research scientist upon formation of a unit focusing on the application of recombinant DNA technology to vaccine development. He subsequently held positions of increasing responsibility and, as Vice President, Research & Development at Sanofi Pasteur, headed a team of approximately 400 specialists, active in all aspects of preclinical vaccine development.

Dr. De Wilde a member of a number of Scientific Advisory Boards, including COVAX Independent Product Group and other COVID related advisory bodies.

Dr. De Wilde received his degree in Chemistry from the Free University of Brussels in 1971, followed by a Ph.D. in Biochemistry in 1976. He carried out postdoctoral work at the University of Wisconsin, Madison (U.S.) and the University of Ghent (Belgium). Dr. De Wilde authored over 50 publications during the early part of his career.

Dr. De Wilde is also a Senior Scientific Advisor on all three of VBI’s Scientific and Clinical Advisory Boards.

Blaine McKee, Ph.D.

Director

Blaine McKee, Ph.D., is the President and Chief Executive Officer at Walden Biosciences, a biotechnology company focused on transforming the treatment of kidney disease.

Prior to joining TrisaQ in January 2020, Dr. McKee was Executive Vice President and Chief Business Officer of ImmunoGen, Inc. Dr. McKee also previously served as Head of Corporate Development at Shire PLC, where he led corporate strategy, M&A, due diligence, commercial assessment, and alliance management efforts. During his four-year tenure at Shire, Dr. McKee was responsible for executing multiple M&A, licensing, and divestment transactions, most recently the sale of Shire’s commercial oncology franchise to Servier S.A.S. for ~$2.4 billion. Dr. McKee’s most significant and recent roles prior to joining Shire include Executive Vice President and Chief Business Officer of 480 Biomedical, as well as a 15-year tenure at Genzyme Corporation, which culminated in the role of Senior Vice President of Strategic Development for the Oncology, Transplant, and Multiple Sclerosis divisions.

Dr. McKee previously served as Director for the New York Pharma Forum. He received a Bachelor of Science in Chemistry from Colorado State University, a Ph.D. in Organic Chemistry from the Massachusetts Institute of Technology (MIT), and an MBA in Finance from the MIT Sloan School of Management.

Jeff Baxter, FCMA

President, CEO, and Director

Mr. Baxter joined VBI in September of 2009 as Chief Executive Officer. Previously, he was a managing partner for the venture capital firm, The Column Group. Until July of 2006, Mr. Baxter was SVP, R&D Finance and Operations, of GlaxoSmithKline (GSK). In his 19 years of pharma experience, he has held line management roles in commercial, manufacturing and IT and the office of the CEO. His most recent position in R&D included responsibility for finance, pipeline resource planning and allocation, business development deal structuring and SROne (GSK’s in-house $125M venture capital fund). He also chaired GSK’s R&D Operating Board. Prior to GSK, he worked at Unilever and British American Tobacco. Mr. Baxter was educated at Thames Valley University and is a Fellow of the Chartered Institute of Management Accountants (FCMA).

Nell Beattie

Chief Financial Officer, Head of Corporate Development, and Director

Ms. Beattie joined VBI in 2015 after completing her M.B.A at the Tuck School of Business at Dartmouth College. Prior to receiving her M.B.A., she was a consultant at Artisan Healthcare Consulting, where she worked with pharmaceutical and biotechnology companies to develop financial and strategic analyses, as well as provided guidance and support for corporate and business development efforts. Ms. Beattie also holds a B.A. from Dartmouth College.

Eddy A. Bresnitz, M.D., M.S.C.E.

Dr. Bresnitz is an accomplished public health physician bringing over four decades of experience in academia, government public health, and the pharmaceutical industry, with a focus on the development of vaccines and implementation of vaccine policy. Dr. Bresnitz is currently serving as Medical Advisor to the New Jersey State Department of Health’s COVID-19 Response and was formerly the New Jersey State Epidemiologist with successive positions as Assistant, Senior Assistant, and Deputy Commissioner of Health for Public Health Services from 1999-2008. In 2020, Dr. Bresnitz retired from a 12-year career at Merck & Co., Inc., where he served as Medical Director, Global Medical Affairs and Policy, as well as Executive Director, Adult Vaccines, Global Vaccine Medical Affairs. As Executive Director, Dr. Bresnitz was responsible for the development and execution of medical affairs strategies for the adult vaccine portfolio that included pneumococcal, herpes zoster, and the hepatitis A and B vaccines, Vaqta and Recombivax HB, respectively. Prior to his service in the New Jersey State Government, Dr. Bresnitz was Chairman of the Department of Community and Preventive Medicine at Drexel University’s School of Medicine.