VBI Vaccines Announces Poster Presentation at 2024 ASCO Annual Meeting Highlighting New Interim Phase 2b Data from VBI-1901 in Recurrent Glioblastoma Patients

Rhea-AI Summary

VBI Vaccines announced that new interim tumor response data from its ongoing Phase 2b study of VBI-1901, a cancer vaccine candidate for recurrent glioblastoma (GBM), will be presented at the 2024 ASCO Annual Meeting. The data include updates on patients from the initial evaluation and new patients randomized into the study. The study involves 60 patients, randomized into two arms: VBI-1901 combined with GM-CSF, and standard-of-care treatment. Key endpoints are safety, overall survival, tumor response rate, progression-free survival, immunologic responses, corticosteroid use reduction, and quality of life changes.

Positive

• New interim data from the Phase 2b study of VBI-1901 will be presented at the 2024 ASCO Annual Meeting.
• The study includes updates on tumor response data from both initially evaluable and newly randomized patients.
• Key endpoints of the study include safety, overall survival, tumor response rate, and progression-free survival.
• The FDA recognizes statistically significant improvements in overall survival as criteria for new oncology drug approvals.

Negative

• The study is still in the interim phase, meaning final results and conclusions are not yet available.
• There is a possibility of intolerable toxicity or disease progression in patients receiving standard-of-care treatment.
• The effectiveness of VBI-1901 in achieving statistically significant improvements in overall survival is yet to be demonstrated.

CAMBRIDGE, Mass.--(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 new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

The presentation at ASCO will provide an update to the encouraging data previously shared at the World Vaccine Congress Washington in April, including additional data from those initially evaluable patients, as well as data from new patients who have since been randomized into the Phase 2b study.

Presentation Details

• Title: Randomized Phase 2b trial of a CMV vaccine immunotherapeutic candidate (VBI-1901) in recurrent glioblastomas
• Date: Saturday, June 1, 2024
• Poster Session: Central Nervous System Tumors
• Poster Session Time: 9:00 AM – 12:00 PM CDT

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, more than 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:

1. 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

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 of the COVID-19 endemic 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 and Current Reports on Form 8-K. 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/20240522640304/en/

VBI

Nicole Anderson

Director, Corporate Communications & IR

(617) 830-3031 x124

IR@vbivaccines.com

Source: VBI Vaccines Inc.

FAQ

What is VBI-1901?

VBI-1901 is a cancer vaccine immunotherapeutic candidate developed by VBI Vaccines for treating recurrent glioblastoma.

When and where will the Phase 2b data of VBI-1901 be presented?

The data will be presented at the 2024 ASCO Annual Meeting on June 1, 2024, during the Central Nervous System Tumors Poster Session.

What are the key endpoints of the Phase 2b study for VBI-1901?

Key endpoints include safety, overall survival, tumor response rate, progression-free survival, immunologic responses, corticosteroid use reduction, and quality of life changes.

How many patients are involved in the Phase 2b study of VBI-1901?

The study involves up to 60 patients with first recurrent glioblastoma.

What are the two arms of the study for VBI-1901?

Patients are randomized into two arms: VBI-1901 combined with GM-CSF and standard-of-care treatment with either intravenous carmustine or oral lomustine.

What has the FDA recognized as criteria to support new oncology drug approvals?

The FDA has recognized statistically significant improvements in overall survival relative to a randomized control arm as criteria to support new oncology drug approvals.