Drugs / VBI-1901
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03382977 | Dec 2017 → Jul 2025 | glioblastoma | VBI Vaccines Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2024-05-29 | VBI Vaccines Inc. | Results VBI Vaccines Announces New Tumor Response Data from Ongoing Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma Patients vbivaccines.com ↗
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 |
| 2024-04-03 | VBI Vaccines Inc. | Results VBI Vaccines Presents Encouraging Early Tumor Response Data From Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma vbivaccines.com ↗
2 stable disease (SD) have been observed in the VBI-1901 arm to-date |
| 2023-11-20 | VBI Vaccines Inc. | Results VBI Vaccines Presents Additional Biomarker Data from Phase 1/2a Study of VBI-1901 in Recurrent GBM at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting vbivaccines.com ↗
New proof-of-mechanism data demonstrated that vaccination with VBI-1901 was associated with T-cell activation capable of trafficking across the blood-brain barrier to the tumor microenvironment, an area which is known to be highly immunosuppressive and difficult to infiltrate. |
| 2022-11-22 | VBI Vaccines Inc. | Results VBI Vaccines Presents Additional Phase 1/2a Data from VBI-1901 in Recurrent GBM at the 2022 Society for Neuro-Oncology (SNO) Annual Meeting vbivaccines.com ↗
Median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care 1 |
| 2022-06-22 | VBI Vaccines Inc. | Regulatory VBI Vaccines Receives U.S. FDA Orphan Drug Designation for VBI-1901 for the Treatment of Glioblastoma vbivaccines.com ↗ |
| 2022-06-06 | VBI Vaccines Inc. | Results VBI Vaccines Presents Updated Phase 2a Tumor Response and Overall Survival Data for VBI-1901 in Recurrent GBM at the 2022 ASCO Annual Meeting vbivaccines.com ↗
Two (2) partial tumor responses and five (5) stable disease seen across Part A and Part B |
| 2021-06-08 | VBI Vaccines Inc. | Regulatory VBI Vaccines Granted FDA Fast Track Designation for VBI-1901 for the Treatment of Recurrent GBM vbivaccines.com ↗
Designation granted based on data from the Phase 1/2a study of VBI-1901 in recurrent GBM patients |
| 2021-05-20 | VBI Vaccines Inc. | Results VBI Vaccines to Present Updated Phase 2a Tumor Response and Overall Survival Data for VBI-1901 in Recurrent GBM at 2021 ASCO Annual Meeting vbivaccines.com ↗
The e-poster presentation will highlight patient-specific tumor response data and improvement in overall survival (OS) compared to historical controls across both study arms: |
| 2020-09-17 | VBI Vaccines Inc. | Results VBI Vaccines Announces Biomarker Data from VBI-1901 Phase 1/2a Study in Recurrent GBM Presented at ESMO Virtual Congress 2020 vbivaccines.com ↗
This analysis suggests that VBI-1901 is able to induce a CMV antigen-specific immune response to target a broader set of CMV antigens beyond what is expressed in VBI-1901, evident by HLA analysis and functional T cell assays. |
| 2020-06-22 | VBI Vaccines Inc. | Results VBI Vaccines Announces Data from VBI-1901 Presented at AACR 2020: Partial Response Observed, Promising Biomarker Strategy Identified vbivaccines.com ↗
Emerging data from the ongoing Phase 1/2a study suggest that patients with a normal baseline CD4+/CD8+ T cell ratio may be more likely to experience delayed progression or tumor reduction, reflected as a tumor response. |
| 2020-05-15 | VBI Vaccines Inc. | Results VBI Vaccines Announces Upcoming Poster Presentation of Phase 1/2a data of VBI-1901 in Recurrent GBM Patients at AACR Virtual Annual Meeting vbivaccines.com ↗
Moreover, a baseline biomarker was identified in patients in the Part A dose-ranging phase of the study that may help predict patients most likely to respond to, and derive clinical benefit from, treatment with VBI-1901. |
| 2020-03-03 | VBI Vaccines Inc. | Results VBI Vaccines Provides Update on Part A of Ongoing Phase 1/2a Study Demonstrating Overall Survival Benefit for VBI-1901 Vaccine Responders in Recurrent GBM Patients vbivaccines.com ↗ |
| 2019-10-24 | VBI Vaccines Inc. | Results VBI Vaccines to Present New Immuno-Oncology Data at the World Vaccine Congress Europe 2019 vbivaccines.com ↗
In Part A, three out of the six (3/6) patients in the high-dose cohort had evidence of stable disease by magnetic resonance imaging (MRI), which correlated with vaccine-induced T-cell responses. |
| 2019-06-04 | VBI Vaccines Inc. | Results VBI Vaccines Reports Data from Part A of the Ongoing Phase 1/2a Study of VBI-1901 in Recurrent Glioblastoma (GBM) Patients at ASCO 2019 vbivaccines.com ↗
Three patients in high dose (10 µg) cohort showed evidence of stable disease by MRI |
| 2019-04-23 | VBI Vaccines Inc. | Results VBI Vaccines Provides Update on GBM Program and Announces Upcoming Conference Call vbivaccines.com ↗
Based on safety and immunogenicity, the highest dose tested in Part A of the ongoing Phase 1/2a study of VBI-1901 in recurrent GBM, 10mcg, has been selected as the optimal dose level to test in Part B of the study. |
| 2018-09-25 | VBI Vaccines Inc. | Results VBI Vaccines Announces Second Positive DSMB Review in Phase 1/2a Study of VBI-1901 in Recurrent Glioblastoma (GBM) Patients vbivaccines.com ↗
The DSMB reviewed the complete safety data from the fully enrolled, intermediate-dose patient cohort, and unanimously recommended the continuation of the study without modification. |
| 2018-04-17 | VBI Vaccines Inc. | Results VBI Vaccines Announces Positive DSMB Review in Phase 1/2a Study of VBI-1901 in Recurrent Glioblastoma (GBM) Patients vbivaccines.com ↗
the independent Data and Safety Monitoring Board (DSMB) unanimously recommended the continuation of the study without modification. |
| 2017-11-10 | VBI Vaccines Inc. | Results VBI Vaccines to Present New Preclinical Data for its GBM Immunotherapy, VBI-1901, at SITC 2017 vbivaccines.com ↗
Following intradermal injection of VBI-1901, migratory dendritic cells at the injection site were confirmed to stimulate potent, adaptive T-cell immunity. |
| 2017-08-28 | VBI Vaccines Inc. | Results VBI Vaccines to Present New Preclinical Data for its GBM Immunotherapy, VBI-1901, at the Immuno-Oncology Summit vbivaccines.com ↗
After two doses, boosting of CMV-specific T-cell responses were seen in all animals, an observation consistent with other recent anti-CMV dendritic cell vaccine clinical studies against GBM where meaningful improvement in overall survival was observed. |
| 2017-08-15 | VBI Vaccines Inc. | Regulatory VBI Vaccines Announces FDA Acceptance of Investigational New Drug Application for VBI-1901 to Treat Glioblastoma Multiforme vbivaccines.com ↗ |
| 2016-08-29 | VBI Vaccines Inc. | Results VBI Vaccines to Present at the Immuno-Oncology Summit vbivaccines.com ↗
New preclinical data demonstrates VBI-1901’s ability to recruit and activate dendritic cells, as evidenced by induction of proinflammatory IL-8 cytokine and CCL3 chemokine responses in an ex vivo model. |
All press releases naming this drug 33 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VBI-1901 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03382977 ↗ |