VBI Vaccines Announces Dosing of First Patients in Phase 2b Study of VBI-1901 in Recurrent GBM
- First patients dosed in Phase 2b study of VBI-1901
- Encouraging Phase 1/2a study results with 44% disease control rate achieved
- Median overall survival of 12.9 months, comparing favorably to standard-of-care
- FDA granted Fast Track and Orphan Drug Designation to VBI-1901
- None.
- Multi-center, randomized, controlled, open-label study to enroll up to 60 patients with first recurrent GBM
- FDA has granted both Fast Track Designation and Orphan Drug Designation to VBI-1901 in the recurrent setting, following encouraging Phase 1/2a study results
- Interim data analysis expected mid-year 2024, subject to speed of enrollment
Andrew B. Lassman, M.D., Chief of Neuro-Oncology at Columbia University Vagelos College of Physicians and Surgeons, Associate Director for Clinical Trials at the NCI-designated Herbert Irving Comprehensive Cancer Center, and principal investigator of the study, commented, “Based on the pre-clinical and clinical data seen in earlier stages of this study, I look forward to demonstrating the potential value of VBI-1901, relative to current standard of care, in my patients in this next phase of clinical development, with the hope to provide meaningful benefit against a brain tumor that is notoriously aggressive with a high mortality rate.”
Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, commented, “Median overall survival in the recurrent GBM setting is just eight months, making any advancement in patient care critical. As we work to offer new hope to the patients, family members, and caretakers who are battling this devastating and historically treatment-resistant brain tumor, we are excited to kick-off this next phase of development for VBI-1901.”
In the Phase 1/2a study of VBI-1901 in the rGBM setting, extensive biomarker panels suggested normal baseline CD4+/CD8+ T-cell ratios, which is a measure of immunological fitness, along with boosting of cytomegalovirus (CMV) gB specific antibody responses were correlated with tumor and clinical responses. These learnings have been incorporated into patient enrollment eligibility criteria for the Phase 2b study to help identify patient populations that may be more likely to respond to treatment with VBI-1901.
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
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
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
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, 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
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 impact of general economic, industry or political conditions in
View source version on businesswire.com: https://www.businesswire.com/news/home/20230907734558/en/
VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com
Source: VBI Vaccines Inc.