- Lot-to-lot manufacturing consistency of
Sci-B-Vac®, the primary endpoint, was demonstrated
- Sci-B-Vac® achieved seroprotection rates of
99.3% and 90.4% after three and two doses, respectively, compared
with 94.8% and 51.6% with Engerix-B®, respectively
- No safety signals observed – safety profile
remains consistent with known profile of the vaccine
- Regulatory submissions in U.S., Europe, and
Canada expected to begin in the second half of 2020
- VBI to host conference call and webcast today,
Thursday, January 9, 2020 at 8:30AM ET
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage
biopharmaceutical company developing next-generation infectious
disease and immuno-oncology vaccines, today reported top-line data
from CONSTANT, the second pivotal Phase 3 study, assessing
lot-to-lot manufacturing consistency of Sci-B-Vac®, the company’s
trivalent hepatitis B (HBV) vaccine, and comparing safety and
immunogenicity of Sci-B-Vac® to GlaxoSmithKline’s
currently-marketed HBV vaccine, Engerix-B®. The Phase 3 study,
which enrolled 2,838 adults, age 18-45 years, met both the primary
and secondary endpoints.
“We are thrilled with the results of the CONSTANT study, which
once again demonstrate Sci-B-Vac® is a safe and highly-potent
option for vaccination against hepatitis B, and which now enable us
to finalize our regulatory package as we work towards submissions
in the U.S., Europe, and Canada starting in the second half of
2020,” said Jeff Baxter, VBI’s President and CEO.
The primary endpoint of the study was lot-to-lot consistency for
immune response, as measured by geometric mean concentration (GMC)
of antibodies across three independent, consecutively-manufactured
lots of Sci-B-Vac®, four weeks after the third vaccination.
Together with the positive safety and immunogenicity results of the
PROTECT Phase 3 study – data which were announced in June 2019 –
these data comprise the basis for the regulatory submissions in the
U.S., Europe, and Canada, expected to begin in the second half of
2020.
A secondary endpoint of the study was non-inferior
immunogenicity as measured by seroprotection rates (SPR) at day
196, one month after completion of the full course of vaccination
with either Sci-B-Vac® or Engerix-B®. At day 196, the pooled SPR in
subjects who received Sci-B-Vac® was 99.3% compared to 94.8% for
those who received Engerix-B® – a difference of 4.49%; 95%
Confidence Interval (CI) [2.90%, 6.63%] – up from 90.4% for
Sci-B-Vac® and 51.6% for Engerix-B® at day 168, after only two
vaccinations. In addition to demonstrating non-inferiority, the SPR
achieved with Sci-B-Vac® compared with Engerix-B® was higher after
both two and three vaccinations.
The safety and tolerability seen in CONSTANT were consistent
with the known safety profile of Sci-B-Vac®. No new safety risks
were identified and no safety signals were observed in either
cohort. The integrated safety data analysis from both the PROTECT
and CONSTANT studies is underway.
An exploratory analysis in CONSTANT also compared the SPR after
two doses of Sci-B-Vac® (at day 168) to the SPR after three doses
of Engerix-B® (at day 196). At these times points, the SPR was
90.4% for Sci-B-Vac® and 94.8% for Engerix-B® – a difference of
-4.3%; 95% CI [-6.48%, -1.90%]. As per the commonly-used
statistical margin of non-inferiority for vaccines1, defined as the
lower limit of the 95% CI being above -10%, this analysis
demonstrated non-inferiority after two doses of Sci-B-Vac® (at day
168) compared with three doses of Engerix-B® (at day 196).
Similarly, at these time points, preliminary data from the
integrated immunogenicity analysis of both the PROTECT and CONSTANT
studies in subjects age 18-45 years demonstrate a difference in SPR
of -4.2%; 95% CI [-6.38%, -1.99%]. The two vs. three dose
comparison is not part of the regulatory approval process and would
not be included in the expected indication the company will seek,
but does contribute to the robust immunogenicity profile of
Sci-B-Vac®.
Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer
commented, “With the completion of the pivotal Phase 3 program, we
believe the full data package of Sci-B-Vac® supports its ability to
address significant unmet medical needs in North America and in
Europe. As demonstrated in the pivotal Phase 3 program, Sci-B-Vac®
can safely confer higher rates of protection in older adults and in
adults with key immuno-compromising conditions. Moreover, in
younger healthy adults who need protection safely and quickly, we
believe Sci-B-Vac® has demonstrated its ability to be highly
competitive, achieving protection rates of 90% after two
vaccinations and 99% after three vaccinations.”
Conference Call and Webcast Details VBI Vaccines will
host a conference call and webcast with accompanying slides on
Thursday, January 9, 2020 at 8:30 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: http://public.viavid.com/index.php?id=137500.
A replay of the webcast will be archived on the company’s
website for 30 days following the live conference call.
To listen to the live conference call, please dial:
- Toll-free U.S. & Canada Dial-In: 877-705-6003
- International Dial-In: 201-493-6725
- Conference ID: 13697787
About CONSTANT – Lot-to-Lot Consistency Study CONSTANT is
a double-blind, four-arm, randomized, controlled study that
enrolled 2,838 adult subjects, age 18-45 years, who were randomized
in a 1:1:1:1 ratio into 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. Under the planned
dosing schedule, subjects were vaccinated at months zero, one, and
six.
The primary endpoint of this study was:
- 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.
- This primary endpoint was prospectively defined across two
patient sets, with demonstration of lot-to-lot consistency required
in only one of the two sets – the detailed study results will be
discussed with the FDA as part of the regulatory approval
process.
The secondary endpoints were to evaluate safety and efficacy of
Sci-B-Vac® vs. Engerix-B®.
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 a trivalent hepatitis B vaccine, Sci-B-Vac®,
which is approved for use in Israel and 10 other countries and
recently completed its Phase 3 program in the U.S., Europe, and
Canada, and with an immunotherapeutic in development for a
functional cure for chronic hepatitis B. VBI’s eVLP Platform
technology allows for the development of enveloped virus-like
particles (eVLP) 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 glioblastoma (GBM) vaccine
immunotherapeutic candidate and a prophylactic CMV vaccine
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,
including the approval of Sci-B-Vac® in the U.S., Europe, and
Canada following the completion of its recent Phase 3 studies; 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.
References 1. Donken R., de Melker H.E., Rots N.Y.,
Berbers G., Knol M.J. Comparing vaccines: A systemic review of the
use of non-inferiority margin in vaccine trials. Vaccine. 2015; 33:
1426-1432
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200109005179/en/
VBI Investor & Media Contact Nicole Anderson
Director, Corporate Communications & IR Phone: (617) 830-3031
x124 Email: info@vbivaccines.com
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