VBI Vaccines Announces Positive Top-Line Results from PROTECT, a
Pivotal Phase 3 Study of Sci-B-Vac®
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) [11.2%, 18.6%]
- 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 [12.2%,
20.7%]
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 [8.4%, 40.4%]
- 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
[14.3%, 28.0%]
“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:
|
Days Post-1st Vaccination |
|
Day 28 |
Day 56 |
Day 168 |
Day 196 |
Day 336 |
|
After 1 Dose |
After 2 Doses |
After 3 Doses |
SPR (%) : All Ages (18+) |
|
|
|
|
|
- Engerix-B® |
7.7% |
23.9% |
27.4% |
76.5% |
68.8% |
- Sci-B-Vac® |
16.0% |
51.5% |
66.0% |
91.4% |
89.0% |
|
|
|
|
|
|
- Difference in SPR[95% CI] |
8.4% [5.1%, 11.7%] |
27.6% [22.7%, 32.3%] |
38.5% [33.7%, 43.2%] |
14.9% [11.2%, 18.6%] |
20.2% [16.1%, 24.3%] |
SPR (%) : Ages 18-44 |
|
|
|
|
|
- Engerix-B® |
9.6% |
37.0% |
39.0% |
91.1% |
87.1% |
- Sci-B-Vac® |
28.8% |
76.0% |
87.2% |
99.2% |
97.5% |
|
|
|
|
|
|
- Difference in SPR[95% CI] |
19.2% [9.9%, 28.8%] |
39.0% [27.4%, 49.4%] |
48.2% [37.6%, 57.7%] |
8.1% [3.4%, 14.2%] |
10.4% [4.2%, 17.5%] |
Analysis based on Per Protocol Dataset
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.
- Website Home: http://www.vbivaccines.com/
- News and Insights: http://www.vbivaccines.com/wire/
- Investors: http://www.vbivaccines.com/investors/
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 AndersonAssociate, Corporate CommunicationsPhone: (617)
830-3031 x124Email: info@vbivaccines.com
VBI Investor Contact
Nell BeattieChief Business OfficerEmail: IR@vbivaccines.com
VBI Media Contact
Burns McClellan, Inc. Robert Flamm, Ph.D. Phone: (212)
213-0006Email: rflamm@burnsmc.com
VBI Vaccines (NASDAQ:VBIV)
Historical Stock Chart
From Mar 2024 to Apr 2024
VBI Vaccines (NASDAQ:VBIV)
Historical Stock Chart
From Apr 2023 to Apr 2024