- Among the 7 patients on VBI-1901 treatment long enough to have
1+ MRI scan at the time of analysis, one partial tumor response
(PR) and two stable disease (SD) observations have occurred as of
May 15, 2024
- The partial response, which demonstrated a 67% reduction in
tumor size vs. baseline, was observed at week 6, after 2 doses of
VBI-1901
- The disease control rate (DCR) in the VBI-1901 study arm was
43% (n=3/7) compared to 0% in the control arm (n=0/6) – n=5/6
patients in the control arm have experienced a 2-8x increase in
tumor size vs. baseline and have been taken off study protocol
- FDA has granted both Fast Track Designation and Orphan Drug
Designation to VBI-1901 in recurrent GBM following previous Phase
1/2a study results
- Additional interim data expected Q4 2024, including additional
tumor response data and initial survival data from early-enrolled
participants, 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 new interim tumor
response data from the ongoing randomized, controlled Phase 2b
study of VBI-1901, the Company’s immunotherapeutic cancer vaccine
candidate, in recurrent glioblastoma (rGBM) patients. These data
will be presented in a poster session at the 2024 American Society
of Clinical Oncology (ASCO) Annual Meeting on Saturday, June 1,
2024.
David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, said:
“The tumor responses we have seen to date are incredibly
encouraging, and, like the tumor responses did in the Phase 1/2a
study, I am excited to see how this translates to clinical and
survival outcomes later this year. The approved treatments for
recurrent GBM patients have limited to no efficacy, which is
consistent with the data seen in the standard-of-care arm in this
study. VBI-1901’s ability to stimulate an immune response capable
of generating a disease control rate of 43% at this interim stage
of the study, including a partial response, is hopefully an
indication of the potential of this candidate to make a meaningful
difference in the lives of patients, providers, and families.”
Jeff Baxter, VBI’s President and CEO, said: “These data
represent a considerable advancement in our effort to make a
difference in the fight against GBM. Throughout the remainder of
2024, we expect to have additional tumor response data and initial
survival data. Pending the strength of these clinical data, we
believe we can start discussions with the FDA around what an
accelerated development and approval pathway looks like, under our
Fast Track and Orphan Drug Designations.”
Phase 2b Data Poster Highlights As of May 15, 2024, 23
patients had been randomized 1:1 to either the active treatment
arm, VBI-1901, or to the control treatment arm
(standard-of-care).
- Active Study Arm: VBI-1901 + Granulocyte-Macrophage Colony
Stimulating Factor (GM-CSF)
- 11 patients have been randomized – tumor response data was
available for 7 of those patients as of May 15, 2024
- One (1) PR and two (2) SD observations seen to date
- The patient with the PR saw a 67% tumor reduction compared to
baseline at week 6, after receiving two monthly doses of
VBI-1901
- 43% (n=3/7) disease control rate achieved in evaluable patients
to date
- 2 additional patients appear to be experiencing stabilization
of tumor growth after their second dose of VBI-1901, but do not yet
meet the threshold to qualify as stable disease
- Control Study Arm: Standard-of-Care (SoC) Therapy –
Carmustine or Lomustine
- 12 patients have been randomized – tumor response data was
available for 6 of those patients as of May 15, 2024
- No tumor responses have been observed in the SoC arm (n=0/6; 0%
DCR)
- 5 evaluable patients have experienced tumor progression of 2-8x
increase in tumor size and have been taken off study protocol
Tumor response rates are an objective measure of treatment
efficacy in oncology trials. In VBI’s previous Phase 1/2a study of
VBI-1901 in rGBM, a 44% disease control rate was observed (n=7/16),
which translated to clinical improvements in overall survival, with
a median overall survival (mOS) of 12.9 months after treatment with
VBI-1901 compared to the 8-month mOS historical benchmark for
standard-of-care chemotherapy treatment.
ASCO Poster Details
- Title: Randomized Phase 2b trial of a CMV vaccine
immunotherapeutic candidate (VBI-1901) in recurrent
glioblastomas
- Abstract Number: TPS2100
- Date & Time: 9:00 AM – 12:00 PM CDT, Saturday, June
1, 2024
- Poster Session: Central Nervous System Tumors
VBI’s poster presentation will be made available on the Posters
page of VBI’s website, under News and Resources, after the Central
Nervous System Tumors poster session concludes on June 1, 2024.
Phase 2b Patient Enrollment Update
- 26 patients have been randomized as of May 28, 2024
- Patient enrollment rate continues to increase, with six (6)
patients randomized in May
- VBI expects the study to be fully enrolled (n=60) by year-end
2024, subject to continued pace of enrollment
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 randomized, controlled Phase 2b study is evaluating overall
survival, tumor response rates, and safety and tolerability of
VBI-1901 as a monotherapy treatment in rGBM patients. There are no
effective, approved treatments available for patients with rGBM,
and median overall survival remains low at approximately eight (8)
months.
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.
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
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, 12,000 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 and a proprietary mRNA-launched eVLP (“MLE”) 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 Company’s ability to regain and maintain compliance
with the listing standards of the Nasdaq Capital Market, the
Company’s ability to satisfy all of the conditions to the
consummation of the transactions with Brii Biosciences, the
Company’s ability to comply with its obligations under its loan
agreement with K2 HealthVentures, the impact of general economic,
industry or political conditions in the United States or
internationally; the impact and continuing effects of the COVID-19
epidemic 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 April 16, 2024, and filed with the Canadian security
authorities at sedarplus.ca on April 16, 2024, 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/20240529424108/en/
VBI Nicole Anderson Director, Corporate Communications
& IR Phone: (617) 830-3031 x124 Email: IR@vbivaccines.com
VBI Vaccines (NASDAQ:VBIV)
過去 株価チャート
から 12 2024 まで 1 2025
VBI Vaccines (NASDAQ:VBIV)
過去 株価チャート
から 1 2024 まで 1 2025
