VBI Vaccines Announces Dosing of First Recurrent GBM Patient in Part B of Ongoing Phase 1/2a Study of VBI-1901
July 29 2019 - 8:00AM
VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage
biopharmaceutical company developing next-generation infectious
disease and immuno-oncology vaccines, today announced that the
first patient has been dosed in Part B of the ongoing Phase 1/2a
clinical study of VBI-1901, VBI’s oncology immunotherapeutic, in
recurrent glioblastoma (GBM) patients.
“We were very encouraged by the results we saw
in Part A of the study, notably that three out of the six patients
in the high-dose cohort had evidence of stable disease by magnetic
resonance imaging,” said David Anderson, Ph.D., VBI’s Chief
Scientific Officer. “In part B of the study, we are narrowing the
enrollment criteria to first-recurrent GBM patients so that we may
better assess the potential correlation between immunogenicity and
tumor and clinical responses to VBI-1901. GBM is an incredibly
aggressive and devastating disease with very few treatment options,
and we believe VBI-1901 has the potential to help address this
tragic unmet medical need.”
The ongoing two-part study is a multi-center,
open-label study conducted at The Neurological Institute of New
York Columbia University Medical Center, Dana-Farber Cancer
Institute, and Massachusetts General Hospital.
About the Phase 1/2a Study
Design
VBI’s two-part Phase 1/2a study is a
multi-center, open-label, dose-escalation study of VBI-1901 in up
to 28 patients with recurrent GBM:
- Part
A:— Dose-escalation phase that defined the
safety, tolerability, and optimal dose level of VBI-1901 in
recurrent GBM patients.— This phase enrolled 18 recurrent GBM
patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and
10.0µg.
- Part
B:— Subsequent extension of the optimal
dose level, 10.0 µg, as defined in the Part A dose escalation
phase.— This phase is expected to enroll an expanded cohort
of approximately 10 additional first-recurrent GBM patients.
VBI-1901 is administered intradermally and is
adjuvanted with granulocyte-macrophage colony-stimulating factor
(GM-CSF), a potent adjuvant that mobilizes dendritic cell function.
Patients in both phases of the study will receive the vaccine
immunotherapeutic every four weeks until tumor progression.
Additional information, including a detailed
description of the study design, eligibility criteria, and
investigator sites, is available at ClinicalTrials.gov using
identifier NCT03382977.
About VBI Vaccines
Inc.
VBI Vaccines Inc. (Nasdaq: VBIV) is a
commercial-stage biopharmaceutical company developing a next
generation of vaccines to address unmet needs in infectious disease
and immuno-oncology. VBI is advancing the prevention and treatment
of hepatitis B, with the only commercially-approved trivalent
hepatitis B vaccine, Sci-B-Vac®, which is approved for use in
Israel and 10 other countries and is currently in a Phase 3 program
in the U.S., Europe, and Canada, and with an immunotherapeutic in
development for a functional cure for chronic hepatitis B. VBI’s
eVLP Platform technology allows for the development of enveloped
virus-like particles (eVLP) that closely mimic the target virus to
elicit a potent immune response. Integrating its cytomegalovirus
(CMV) expertise with the eVLP platform technology, VBI’s lead eVLP
program candidates include a prophylactic CMV vaccine candidate and
a glioblastoma (GBM) vaccine immunotherapeutic candidate. VBI is
headquartered in Cambridge, MA with research operations in Ottawa,
Canada and research and manufacturing facilities in Rehovot,
Israel.
Website Home: http://www.vbivaccines.com/
News and Insights:
http://www.vbivaccines.com/wire/
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 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 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
therapeutic candidates; the ability to obtain appropriate or
necessary governmental 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 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
February 25, 2019, and filed with the Canadian security authorities
at sedar.com on February 25, 2019, 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 AndersonAssociate, Corporate
CommunicationsPhone: (617) 830-3031 x124Email:
info@vbivaccines.com
VBI Investor
Contact
Nell BeattieChief Business OfficerEmail:
ir@vbivaccines.com
VBI Media
Contact
Burns McClellan, Inc.Robert Flamm, Ph.D.Phone:
(212) 213-0006Email: rflamm@burnsmc.com
VBI Vaccines (NASDAQ:VBIV)
Historical Stock Chart
From Aug 2024 to Sep 2024
VBI Vaccines (NASDAQ:VBIV)
Historical Stock Chart
From Sep 2023 to Sep 2024