VBI Vaccines Announces New Tumor Response Data from Ongoing Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma Patients
VBI Vaccines shared interim data from the Phase 2b study of its cancer vaccine VBI-1901 in recurrent glioblastoma (rGBM) patients. Results showed a 67% tumor reduction in one patient, with a 43% disease control rate in the treatment group versus 0% in the control group. The FDA has granted Fast Track and Orphan Drug Designations to VBI-1901. Additional data will be available in Q4 2024. The study aims to enroll 60 patients by year-end.
- VBI-1901 achieved a 43% disease control rate in the treatment arm.
- One patient experienced a 67% reduction in tumor size.
- FDA granted Fast Track and Orphan Drug Designations for VBI-1901.
- Previous Phase 1/2a study showed a 44% disease control rate with a median overall survival of 12.9 months.
- Study aims to enroll 60 patients by year-end, indicating strong recruitment.
- No tumor responses were observed in the control arm (0% DCR).
- 5 out of 6 control arm patients experienced 2-8x tumor growth and were taken off the study.
- Interim data only available for 7 patients as of May 15, 2024, limiting the sample size.
Glioblastoma is one of the most aggressive brain tumors with a dismal prognosis. Current treatments often lead to poor outcomes, so any potential new therapy showing promise is noteworthy. The Phase 2b study of VBI-1901 has shown a
However, it is important to await further data, including overall survival metrics, to determine if this immune response translates into a substantial clinical benefit. Fast Track and Orphan Drug Designations from the FDA are encouraging, as they can speed up the development and review process.
The data from the ongoing Phase 2b study of VBI-1901 offers early but promising signs. VBI-1901's DCR of
Moreover, the study design appears robust, comparing VBI-1901 with standard-of-care therapies like carmustine or lomustine. This randomized control trial method adds credibility to the findings, though the limited number of patients (n=7 for VBI-1901 arm) at this stage means conclusions are speculative. Full enrollment and more comprehensive data will be necessary to make a definitive assessment.
For investors, the recent data from VBI-1901’s Phase 2b study positions VBI Vaccines Inc. favorably. The disease control rate of
However, the financial implications of this data hinge on subsequent results and eventual regulatory approval. The anticipated additional data later in 2024 will be critical in determining VBI-1901’s commercial viability. Investors should watch for updates on overall survival and long-term safety data to better assess the candidate’s market potential.
- 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
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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 to0% 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
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
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).
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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
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One (1) PR and two (2) SD observations seen to date
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The patient with the PR saw a
67% tumor reduction compared to baseline at week 6, after receiving two monthly doses of VBI-1901
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The patient with the PR saw a
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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
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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
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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
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
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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
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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
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)
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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
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
Website Home: http://www.vbivaccines.com/
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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
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VBI
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com
Source: VBI Vaccines Inc.
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