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2023-09-06
2023-09-06
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of report (Date of earliest event reported): September 6, 2023
VBI VACCINES INC.
(Exact
name of registrant as specified in its charter)
| British
Columbia, Canada |
|
001-37769 |
|
N/A |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
160
Second Street, Floor 3
Cambridge,
Massachusetts |
|
02142 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
(617)
830-3031
(Registrant’s
telephone number, including area code)
N/A
(Former
Name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4© under the Exchange Act (17 CFR 240.13e-4©) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of exchange on which registered |
| Common
Shares, no par value per share |
|
VBIV |
|
The
NASDAQ Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 Regulation FD Disclosure.
On
September 6, 2023, VBI Vaccines Inc. (the “Company”) issued a press release reporting that its strategic hepatitis B (HBV)
partner, Brii Biosciences announced topline interim results of a Phase 2 study evaluating BRII-179 (VBI-2601) in combination with PEG-IFN-α
for the treatment of chronic hepatitis B. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K
and is incorporated by reference herein. The Company undertakes no obligation to update, supplement or amend the materials attached hereto.
The
information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is being furnished pursuant to Item 7.01 and
shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under
the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and regardless of any general
incorporation language in such filing.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| |
VBI
Vaccines Inc. |
| |
|
|
| Date:
September 6, 2023 |
By:
|
/s/
Jeffrey R. Baxter |
| |
|
Jeffrey
R. Baxter |
| |
|
President
and Chief Executive Officer |
Exhibit
99.1
VBI
Vaccines Partner Brii Biosciences Announces Topline Interim Results of Phase 2 Study Evaluating BRII-179 (VBI-2601) in Combination With
PEG-IFNα for the Treatment of Chronic Hepatitis B
|
● |
BRII-179 (VBI-2601)
as an add-on therapy to standard of care PEG-IFNα increases HBsAg loss rate at the end of treatment and 12 weeks follow up |
|
● |
Significantly
increased seroconversion rate is strongly associated with BRII-179 (VBI-2601) treatment and correlates with the increased rate of
HBsAg loss |
|
● |
Safety findings
are similar to those of PEG-IFNα and BRII-179 (VBI-2601) as previously reported |
CAMBRIDGE,
Mass. (September 6, 2023) – VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI” or the “Company”) today announced
that its strategic hepatitis B (HBV) partner, Brii Biosciences (Brii Bio) (Stock code: 2137.HK), announced topline cohort-level unblinded
Week 36 data from interim analysis of a randomized, placebo-controlled and double-blinded Phase 2 study of BRII-179 (VBI-2601), a first-in-class
Pre-S1/Pre-S2/S therapeutic vaccine, in combination treatment with pegylated interferon-alpha (PEG-IFNα) in chronic hepatitis B
virus (HBV) patients compared with PEG-IFNα only treatment. VBI and Brii Bio reported in previous studies that BRII-179 (VBI-2601)
induced broad antibody and T-cell responses against Pre-S1, Pre-S2, and S epitopes in HBV patients. Brii Bio’s detailed press release
can be found here: https://www.briibio.com/en/media/press-release/20230906/.
“We
share Brii Bio’s excitement about this data and congratulate them on their continued ability to move quickly and execute clinical
programs as they seek to deliver higher hepatitis B functional cure rates,” said Jeff Baxter, President and CEO of VBI. “Brii
Bio’s ongoing commitment, investments, and partnerships in this field continue to reinforce the strategic potential of our partnership
and we look forward to seeing further data from this study and future studies of this first-in-class immunotherapeutic candidate.”
In
July 2023, VBI and Brii Bio announced an expansion of their HBV partnership to include an exclusive global license to develop
and commercialize BRII-179 (VBI-2601), and an exclusive license to develop and commercialize PreHevbri®, VBI’s prophylactic
3-antigen adult HBV vaccine, in the Asia Pacific region, excluding Japan.
About
BRII-179 (VBI-2601) + PEG-IFNα Combination Study
The
Phase 2 study is a multicenter, randomized, double-blind, placebo-controlled, parallel study designed to evaluate the safety and efficacy
of BRII-179 (VBI-2601) as an add-on therapy to PEG-IFNα and NrtI therapy for the treatment of chronic HBV infection. This study
enrolled adult HBV patients in mainland China who had received 24 to 28 doses of PEG-IFNα per treatment guideline, at least 12
months of NrtI therapy, and met a pre-defined criteria for partial response. Subjects were randomized 1:1 to receive BRII-179 (VBI-2601)
or placebo every three weeks for a total of 7 doses over 18 weeks while continuing PEG-IFNα treatment for 48 weeks. Subjects who
met Nrtl discontinuation criteria would stop Nrtl treatment and would be followed up for additional 48 weeks.
About
BRII-179 (VBI-2601)
BRII-179
(VBI-2601) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI’s
prophylactic 3-antigen HBV vaccine candidate and is designed to target enhanced and broad B-cell and T-cell immunity. BRII-179 (VBI-2601)
has been licensed to Brii Biosciences (Brii Bio) under an exclusive global development and licensing agreement. BRII-179 (VBI-2601) is
currently being investigated in two Phase 2 clinical trials in combination with BRII-835 (VIR-2218) and PEG-IFNα as part of a potential
functional cure regimen for the treatment of chronic HBV infection.
About
PreHevbri®
PreHevbri
is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – Pre-S1,
Pre-S2, and S. It is approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel.
The brand names for this vaccine are: PreHevbrio® (US/Canada), PreHevbri® (EU/EEA/UK), and Sci-B-Vac®
(Israel).
Please
visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio® [Hepatitis B Vaccine (Recombinant)],
or please see U.S. Full Prescribing Information.
U.S.
Indication
PreHevbrio
is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults
18 years of age and older.
U.S.
Important Safety Information (ISI)
Do
not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis
B vaccine or to any component of PreHevbrio.
Appropriate
medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.
Immunocompromised
persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.
PreHevbrio
may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection
at the time of vaccine administration.
The
most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection
site, myalgia, fatigue, and headache.
There
is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive
PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).
To
report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Please
see Full Prescribing Information.
About
VBI Vaccines Inc.
VBI
Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment
of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”)
platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power
of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses,
and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts,
with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
Website
Home: http://www.vbivaccines.com/
News
and Resources: http://www.vbivaccines.com/news-and-resources/
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
forward-looking 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 impact of general economic, industry or political conditions in the United States or internationally;
the impact of the COVID-19 pandemic and the continuing effects of the COVID-19 pandemic on our clinical studies, manufacturing, business
plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; 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 pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary
regulatory 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 SEC and
the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 13, 2023, and filed with the
Canadian security authorities at sedar.com on March 13, 2023, 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
Director,
Corporate Communications & IR
Phone:
(617) 830-3031 x124
Email:
IR@vbivaccines.com
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