VBI Vaccines Inc. (Nasdaq:VBIV) (TSX:VBV) (“VBI”) announced today
the initiation of the global Phase 3 clinical program for
Sci-B-Vac
®, its third-generation hepatitis B
vaccine, with the commencement of patient dosing on December 18,
2017.
The Phase 3 program will be a global 15-month program consisting
of two concurrent Phase 3 studies – a safety and immunogenicity
study (PROTECT) and a lot-to-lot consistency study (CONSTANT),
enrolling a total of approximately 4,800 subjects. The Phase 3
program will be conducted at approximately 40 sites across the
U.S., Europe, and Canada.
Dr. Francisco Diaz-Mitoma, VBI’s Chief Medical Officer,
commented, “The initiation of this Phase 3 program is a significant
milestone for VBI. There is an extensive safety and efficacy
data package that currently exists for Sci-B-Vac, with
approximately 2,000 subjects in past clinical trials and over
500,000 subjects who have received the vaccine in the commercial
setting. Pending data from this Phase 3 program, we expect to
submit marketing authorization applications to U.S., European, and
Canadian regulatory authorities in 2019. We believe there is
a recognized need for an improved Hepatitis B vaccine and we are
committed to advancing Sci-B-Vac through Phase 3 development as
quickly as possible.”
Dr. Nathan Segall, a certified internal medicine, allergy, and
immunology specialist at Clinical Research Atlanta and a Principal
Investigator in the program, added, “Sci-B-Vac is the only
commercially-available vaccine that contains the pre-S1 and pre-S2
surface antigens. The field is looking forward to seeing the
results of this pivotal program, adding to the growing body of
research which suggests that the inclusion of these two antigens
may prove more immunogenic, especially in subjects that currently
do not respond optimally to current standard of care.”
About PROTECT – Safety and Immunogenicity
Study
PROTECT will be a double-blind, two-arm, randomized, controlled
study. Approximately 1,600 adult subjects, 18 years of age and
older, will be randomized in a 1:1 ratio to receive either a
three-dose course of Sci-B-Vac 10μg or a three-dose course of the
control vaccine, Engerix-B® 20μg. Enrollment will be stratified by
age group.
The co-primary objectives of the study will be:
- To demonstrate non-inferiority of the seroprotection rate
induced by Sci-B-Vac vs. Engerix-B® four weeks after the third
vaccination in adults age 18 and older.
- To demonstrate superiority of the seroprotection rate induced
by Sci-B-Vac vs. Engerix-B® four weeks after the third vaccination
in adults older than 45 years of age.
The study will also include multiple secondary objectives 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 will be a double-blind, four-arm, randomized,
controlled study. Approximately 3,200 adult subjects, age 18-45
years, will be randomized in a 1:1:1:1 ratio to receive one of four
three-dose courses: Lot A of Sci-B-Vac 10μg, Lot B of Sci-B-Vac
10μg, Lot C of Sci-B-Vac 10μg, or the control vaccine Engerix-B®
20μg.
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®.
About Sci-B-Vac®
Sci-B-Vac® is a licensed third-generation
hepatitis B vaccine that has demonstrated safety and efficacy in
over 500,000 patients. Sci-B-Vac is currently approved for use in
Israel and in 14 other countries. In contrast to second-generation
hepatitis B vaccines, which contain only one surface antigen (the S
antigen), Sci-B-Vac contains the S antigen and the pre-S1 and
pre-S2 surface antigens. The composition of Sci-B-Vac may prove
more immunogenic in subjects that currently do not respond
optimally to second-generation vaccines.
To learn more about Sci-B-Vac®, visit:
https://www.vbivaccines.com/sci-b-vac/
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a commercial-stage
biopharmaceutical company developing a next generation of vaccines
to address unmet needs in infectious disease and immuno-oncology.
VBI’s first marketed product is Sci-B-Vac®, a
hepatitis B (HBV) vaccine that mimics all three viral surface
antigens of the hepatitis B virus; Sci-B-Vac is approved for use in
Israel and 14 other countries. 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. VBI is advancing a pipeline of eVLP vaccines, with
lead programs in cytomegalovirus (CMV) and glioblastoma multiforme
(GBM). VBI is also advancing its LPV™ Thermostability Platform, a
proprietary formulation and process that enables vaccines and
biologics to preserve stability, potency, and safety. VBI is
headquartered in Cambridge, MA with research operations in Ottawa,
Canada and research and manufacturing facilities in Rehovot,
Israel.
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VBI Contact
Nicole Anderson, Communications ExecutivePhone: (617) 830-3031
x124Email: info@vbivaccines.com
VBI Investor Contact
Nell BeattieChief Business OfficerEmail: IR@vbivaccines.com
VBI Media Contact
Matt Middleman, M.D.LifeSci Public RelationsPhone: (646)
627-8384Email: matt.midddleman@lifescipublicrelations.com
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 prevailing market conditions 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 March 20, 2017, and filed
with the Canadian security authorities at sedar.com on March 24,
2017, 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.
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