- 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
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
- Endpoints include:
- 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
- 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
- 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230907734558/en/
VBI Contact Nicole Anderson Director, Corporate
Communications & IR Phone: (617) 830-3031 x124 Email:
IR@vbivaccines.com
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