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VBI Vaccines Inc/BC
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2023-09-07
2023-09-07
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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 7, 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 7, 2023, VBI Vaccines Inc. (the “Company”) issued a press release reporting that the first patients have been dosed
in the randomized, controlled Phase 2b study of the Company’s cancer vaccine immunotherapeutic candidate, VBI-1901, in patients
with first recurrent glioblastoma (rGBM). 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 7, 2023 |
By:
|
/s/
Jeffrey R. Baxter |
| |
|
Jeffrey
R. Baxter |
| |
|
President
and Chief Executive Officer |
Exhibit
99.1
VBI
Vaccines Announces Dosing of First Patients in Phase 2b Study of VBI-1901 in Recurrent GBM
| |
● |
Multi-center,
randomized, controlled, open-label study to enroll up to 60 patients with first recurrent GBM |
| |
● |
FDA
has granted both Fast Track Designation and Orphan Drug Designation to VBI-1901 in the recurrent setting, following
encouraging Phase 1/2a study results |
| |
● |
Interim
data analysis expected mid-year 2024, subject to speed of enrollment |
CAMBRIDGE,
Mass. (September 7, 2023) – VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the
pursuit of powerful prevention and treatment of disease, today announced the first patients have been dosed in the randomized, controlled
Phase 2b study of VBI’s cancer vaccine immunotherapeutic candidate, VBI-1901, in patients with first recurrent glioblastoma (rGBM).
The study will assess the safety, tolerability, tumor response rates, and survival following treatment with VBI-1901, as a monotherapy,
at 10 leading neuro-oncology centers across the United States.
Andrew
B. Lassman, M.D., Chief of Neuro-Oncology at Columbia University Vagelos College of Physicians and Surgeons, Associate Director for Clinical
Trials at the NCI-designated Herbert Irving Comprehensive Cancer Center, and principal investigator of the study, commented, “Based
on the pre-clinical and clinical data seen in earlier stages of this study, I look forward to demonstrating the potential value of VBI-1901,
relative to current standard of care, in my patients in this next phase of clinical development, with the hope to provide meaningful
benefit against a brain tumor that is notoriously aggressive with a high mortality rate.”
Francisco
Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, commented, “Median overall survival in the recurrent GBM setting is
just eight months, making any advancement in patient care critical. As we work to offer new hope to the patients, family members, and
caretakers who are battling this devastating and historically treatment-resistant brain tumor, we are excited to kick-off this next phase
of development for VBI-1901.”
In
the Phase 1/2a study of VBI-1901 in the rGBM setting, extensive biomarker panels suggested normal baseline CD4+/CD8+ T-cell ratios, which
is a measure of immunological fitness, along with boosting of cytomegalovirus (CMV) gB specific antibody responses were correlated with
tumor and clinical responses. These learnings have been incorporated into patient enrollment eligibility criteria for the Phase 2b study
to help identify patient populations that may be more likely to respond to treatment with VBI-1901.
Phase
1/2a Study Data Highlights – VBI-1901 10µg + GM-CSF Study Arms
(n=16)
| |
● |
44%
disease control rate achieved (n=7/16) – disease control rate is defined as stable disease (SD) + partial tumor response (PR)
+ complete tumor response (CR) |
| |
● |
2
partial responses (PR) were observed – 1 patient was on treatment for more than 28 months (2.33 years), surviving at least
40 months (3.33 years) as of August 1, 2023, with a maximum tumor reduction of 93% relative to baseline |
| |
● |
5
additional patients demonstrated stable disease (SD) for a sustained period of time |
| |
● |
All
patients with a tumor response (PR or SD) (n=7/16) reached a minimum survival of 12 months |
| |
● |
Median
overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care2 |
Phase
2b Study Design
Multi-center,
randomized, controlled, open-label study in up to 60 patients with first recurrent GBM
| |
● |
Patients
will be randomized in a 1:1 ratio across two study arms: |
| |
○ |
Intradermal
VBI-1901 + GM-CSF: 10 µg dose every 4 weeks until clinical disease progression |
| |
○ |
Monotherapy
standard-of-care: either intravenous carmustine or oral lomustine, every 6 weeks until disease progression or intolerable toxicity |
| |
○ |
Safety
and tolerability |
| |
○ |
Overall
survival (OS) – median and overall |
| |
○ |
Tumor
response rate (TRR) |
| |
○ |
Progression-free
survival (PFS) |
| |
○ |
Immunologic
responses |
| |
○ |
Reduction
in corticosteroid use relative to baseline |
| |
○ |
Change
in quality of life compared to baseline |
The
U.S. Food and Drug Administration (FDA) has considered demonstration of a statistically significant improvement in overall survival relative
to a randomized control arm to be clinically significant and has recognized this as criteria to support the approval of new oncology
drugs.1
For
more information about the Phase 2b study, visit clinicaltrials.gov and reference trial identifier: NCT03382977.
About
GBM and VBI-1901
Scientific
literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and
aggressive malignant primary brain tumors in humans. In the U.S. alone, 14,000 new cases are diagnosed each year. The current standard
of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses
rapidly and has a high mortality.
VBI-1901
is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to
target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan
Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers,
including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other
benefits.
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/
References
| |
1. |
Oncology
Center of Excellence, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) at the
Food and Drug Administration. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Guidance for Industry. FDA.gov.
December, 2018 |
| |
2. |
Taal
W, Oosterkamp HM, Walenkamp AME, et al. Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine
in patients with recurrent glioblastoma (BELOB trial): a randomized controlled phase 2 trial. Lancet Oncol. 2014; 15: 943-953 |
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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