VBI Vaccines Presents Early GBM Tumor Response & Immunologic Data from Part B of Ongoing Phase 1/2a Study of VBI-1901 at the ...
November 22 2019 - 7:00AM
Business Wire
- 33% reduction in tumor size observed in one patient in Part B –
reduction sustained through two consecutive MRI scans
- 6-month overall survival (OS) now available for Part A
demonstrated benefit for vaccine responders (100%) vs.
non-responders (63%)
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage
biopharmaceutical company developing next-generation infectious
disease and immuno-oncology vaccines, today announced the
presentation of interim data from Part B of the ongoing Phase 1/2a
study of VBI-1901, its cancer vaccine immunotherapeutic candidate,
in recurrent glioblastoma (GBM) patients in a poster presentation
at the 24th Annual Scientific Meeting and Education Day of the
Society for Neuro-Oncology (SNO).
Though early in the enrollment process for Part B, the tumor and
immunologic responses seen thus far have aligned with the responses
and benefit observed in Part A of the study. The second patient
enrolled in Part B demonstrates sustained stable disease (SD) after
four monthly vaccinations of VBI-1901, following a 33% reduction in
tumor size after the first vaccination. Among patients evaluable
for response and survival in Part A, follow-up analysis showed the
6-month overall survival (OS) to be 100% in vaccine responders
(6/6) compared with 63% in vaccine non-responders (5/8). Median OS
in the high-dose cohort of Part A, and more broadly among vaccine
responders in Part A, have not yet been reached.
“The clinical outcomes from Part A, the tumor responses we’ve
seen in three of the six patients in the high-dose cohort in Part
A, and now again the tumor response seen in one of the two patients
enrolled and evaluable to-date in Part B continue to be
encouraging,” said David E. Anderson, Ph.D., VBI’s Chief Scientific
Officer. “In an effort to better understand these early tumor
response data, we are also characterizing baseline biomarkers and
immunologic responses, notably T cell responses. Correlations
between immunological biomarkers and tumor/clinical responses will
be refined as more patients are enrolled in Part B of the
study.”
To-date, the ongoing Phase 1/2a open-label multicenter study has
enrolled all 18 recurrent GBM patients in Part A of the study and
four first-recurrent GBM patients in Part B. As of the cut-off date
of November 18, 2019, of the four patients enrolled in Part B of
the study, two were evaluable for immunologic responses, and one
was evaluable for tumor response.
Highlights from Poster Presentation
- Safety:
- VBI-1901 continues to be well-tolerated, with no
vaccine-related safety signals observed
- Immunogenicity:
- The first patient enrolled in Part B demonstrated a robust
immune response, including a substantial increase in T cells –
though the patient continues to be clinically stable, surgical
resection and analysis are ongoing to assess status of tumor
response
- The second patient enrolled in Part B demonstrated a 33%
reduction in tumor size after the first vaccination of VBI-1901 –
classification of stable disease (SD) based on two consecutive
Magnetic Resonance Imaging (MRI) scans
- In the high-dose cohort of Part A, vaccine response correlated
with tumor response, with all three vaccine responders
demonstrating SD for greater than 12 weeks – median overall
survival in these patients has not yet been reached
- Two patients in the high-dose cohort of Part A experienced a
60% reduction in the size of primary tumor – VBI-1901 also induced
and expanded robust T cell responses in these patients
- Correlations between immunologic biomarkers and tumor/clinical
responses will be refined as more patients are enrolled in Part B
of the study
The poster presentation is available on the
“Events/Presentations” page in the “Investors” section of the VBI
Vaccines website.
Poster Presentation/Session Details
- Title: Interim Results of the Extension
Phase of a Phase I/IIa Trial of a Therapeutic CMV Vaccine Against
Recurrent Glioblastoma (GBM) - Abstract: ATIM-26 - Date: Friday,
November 22, 2019 - Time: 7:30PM – 9:30PM MST - Location: Marriott
Desert Ridge Hotel in Phoenix, Arizona, Ballroom Lawn
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 38 patients with
recurrent GBM:
- Part A:
- Dose-escalation phase that defined the safety, tolerability,
and optimal dose level of VBI-1901 adjuvanted with
granulocyte-macrophage colony-stimulating factor (GM-CSF) in
recurrent GBM patients, with any number of prior recurrences.
- This phase enrolled 18 recurrent GBM patients across three dose
cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
- Enrollment completed in December 2018
- Part B:
- Subsequent extension of the optimal dose level, 10.0 µg, as
defined in the Part A dose escalation phase.
- This phase is a two-arm study, enrolling 10 first-recurrent GBM
patients in each arm, assessing 10.0 µg of VBI-1901 in combination
with either GM-CSF or AS01B as immunomodulatory adjuvants.
- Enrollment of the 10 patients in the GM-CSF arm is ongoing,
initiation of enrollment of the 10 patients in the AS01B arm is
expected around year-end 2019, subject to FDA acceptance of the
amended protocol and investigational site institutional review
board approvals.
VBI-1901 is administered intradermally when adjuvanted with
GM-CSF and will be administered intramuscularly when adjuvanted
with AS01B adjuvant system. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191122005043/en/
Nicole Anderson Director, Corporate Communications & IR
Phone: (617) 830-3031 x124 Email: info@vbivaccines.com
VBI Vaccines (NASDAQ:VBIV)
Historical Stock Chart
From Apr 2024 to May 2024
VBI Vaccines (NASDAQ:VBIV)
Historical Stock Chart
From May 2023 to May 2024