VBI Vaccines Presents Additional Phase 1/2a Data from VBI-1901 in Recurrent GBM at the 2022 Society for Neuro-Oncology (SNO) Annual Meeting
November 22 2022 - 08:00AM
Business Wire
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical
company driven by immunology in the pursuit of powerful prevention
and treatment of disease, today announced that additional biomarker
data from the Phase 1/2a study of VBI-1901, the Company’s cancer
vaccine immunotherapeutic candidate in recurrent glioblastoma
(GBM), were presented at the 27th Annual Meeting and Education Day
of the Society for Neuro-Oncology (SNO), on Friday, November 18,
2022.
In the study arms that assessed high-dose VBI-1901 adjuvanted
with granulocyte-macrophage colony-stimulating factor (GM-CSF):
- Two (2) partial tumor responses (PR) were observed in patients
– one patient with a PR remained on treatment protocol for more
than 28 months, reaching survival of at least 32 months as of
November 1, 2022
- An additional five (5) patients demonstrated stable disease for
a sustained period of time
- All tumor responders (n=7) 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-care1
New data from extensive biomarker panels continue to suggest
that normal baseline CD4+/CD8+ T cell ratios, along with boosting
of cytomegalovirus (CMV) gB specific antibody responses, were
correlated with tumor and clinical responses. Six out of seven
tumor responders (n=16) had normal baseline CD4+/CD8+ ratios, and
all seven tumor responders saw boosting of gB antibodies after
treatment with VBI-1901. Higher peak frequencies of CMV
antigen-specific CD4+ T cells were observed in patients with tumor
responses compared to non-responders, suggesting significant
function of CD4+ T cells in controlling tumor growth.
“In an effort to better help address the significant unmet need
for patients with recurrent GBM, a particularly devastating cancer,
we continue to analyze comprehensive biomarker data from this Phase
1/2a study to identify potentially predictive correlates of
response to treatment,” said David E. Anderson, Ph.D., VBI’s Chief
Scientific Officer. “We were pleased to see that the previously
identified CD4+/CD8+ T cell ratio, a measure of immunological
fitness, was associated with tumor responses and encouraging
overall survival benefit compared to historical controls. We plan
to incorporate this learning into the enrollment eligibility
criteria in the next stage of development to help enrich for
potential VBI-1901 responders. We look forward to initiating
randomized, controlled evaluation of VBI-1901 in the recurrent
setting in early 2023.”
This dataset continues to build upon data first shared at ASCO
2021, which resulted in Fast Track Designation granted by the U.S.
Food and Drug Administration (FDA) in June 2021. The data have
subsequently been updated at the World Vaccine & Immunotherapy
Congress in December 2021 and at ASCO 2022.
About VBI-1901 and GBM
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. 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.
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
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Company cautions that such statements involve risks and
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the COVID-19 pandemic and the ongoing effects of the COVID-19
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Company’s filings with the SEC and the Canadian securities
authorities, including its Annual Report on Form 10-K filed with
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References
- 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
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VBI Contact Nicole Anderson Director, Corporate
Communications & IR Phone: (617) 830-3031 x124 Email:
IR@vbivaccines.com
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