VBI-1901 Cancer Vaccine Description
VBI-1901 is a novel bivalent gB/pp65 immunotherapeutic cancer vaccine candidate developed using VBI Vaccines, Inc. (VBI). The Company's enveloped virus-like particle (eVLP) technology targets two highly immunogenic cytomegalovirus (CMV) antigens gB and pp65. VBI-1901's goal is to boost immune responses to them by enhancing its ability to trigger an immune response by attracting immune dendritic cells to the site where the vaccine is injected.
Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM), says VBI.
VBI has applied its eVLP Platform to develop a glioblastoma multiforme therapeutic vaccine candidate. With its novel approach, VBI intends to create a GBM immunotherapy that will stimulate the patient's immune system to identify and kill GBM cancer cells to create a commercially viable therapy that is more effective and tolerable than current treatments.
VBI-1901 is designed to kill glioblastoma and medulloblastoma tumor cells infected with CMV, as many are. The immune system already targets cells infected by viruses. VBI-1901 is designed to coax the body to produce antibodies and white blood cells to kill tumor cells with these antigens. VBI-1901 also includes a granulocyte-macrophage colony-stimulating factor that gives the vaccine more punch.
On June 22, 2022, VBI Vaccines announced that the U.S. FDA granted Orphan Drug Designation for VBI-1901, a vaccine candidate for the treatment of GBM. In June 2021, the FDA also granted Fast Track Designation for VBI-1901 in July 2021 to treat recurrent GBM in patients with first tumor recurrence. For information regarding the Phase 1/2a study and the INSIGhT trial, visit NCT03382977 and NCT02977780.
VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.
VBI-1901 Indication
VBI-1901 is an immunotherapy cancer vaccine that will stimulate the patient's immune system to identify and kill GBM cancer cells. GBM is a common and aggressive malignant primary brain tumor 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. However, even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal, says the Company.
VBI-1901 Dosage
VBI-1901 is co-administered with GM-CSF via the intradermal route in the phase 1 study.
VBI-1901 News
June 22, 2022 - Jeff Baxter, President, and CEO of VBI, commented in a press release, "As recently presented at ASCO, we continue to see strong tumor response data and improvements in overall survival data compared to historical controls in the Phase 2a study of VBI-1901. With this orphan drug status, we look forward to working closely with the FDA and clinical investigators to build on that data, advancing the potential of this program to be a valuable part of the fight against GBM."
January 26, 2022 - VBI Vaccines Inc. announced that David E. Anderson, Ph.D., VBI's Chief Scientific Officer, will present an overview of VBI-1901, the Company's cancer immunotherapeutic for the treatment of glioblastoma, at B. Riley's Oncology Investor Conference on Jan. 28.
December 1, 2021 - VBI Vaccines Inc. announced updated 12-month and 18-month overall survival (OS) data from the Phase 2a study investigating VBI-1901. Building on the data announced in June 2021, which supported the U.S. FDA granting VBI-1901 Fast Track Designation for the treatment of recurrent GBM patients with first tumor recurrence, the updated data includes: Study arm 1: VBI-1901 + granulocyte-macrophage colony-stimulating factor (GM-CSF), 18-month OS: 30% (n=3/10), One patient remains on protocol past week 86, with a 93% tumor reduction relative to initiation of treatment at the beginning of the study, Two additional patients achieved OS of at least 20 months, but are no longer on protocol; Study arm 2: VBI-1901 + GSK's AS01 adjuvant system, 12-month OS: 70% (n=7/10), 18-month OS not yet reached.
August 2, 2021 - VBI Vaccines Inc. published a corporate update. June 2021: FDA Fast Track Designation granted for VBI-1901 + GM-CSF in first recurrent GBM patients; Q4 2021: Expected initiation of a randomized, controlled clinical study with registration potential.
June 8, 2021 - VBI Vaccines Inc. announced that the U.S. FDA granted Fast Track Designation for VBI-1901, VBI's cancer vaccine immunotherapeutic candidate to treat recurrent glioblastoma patients with first tumor recurrence.
March 2, 2021 - VBI Vaccines Inc. announced financial results for the fourth quarter and twelve months ended December 31, 2020. The Company also provided a corporate update and its outlook for 2021. November 2020: Positive data announcement from ongoing Phase 1/2a clinical study of VBI-1901 in recurrent GBM patients, including 2 partial responses (PRs), observed with tumor reduction of more than 50%, and 7 stable disease observations. H2 2021: Expected initiation of a randomized, controlled clinical study with the potential to yield registrational data.
September 14, 2020 - VBI Vaccines Inc. announced its abstract highlighting additional biomarker data from the ongoing Phase 1/2a study of VBI-1901, its cancer vaccine immunotherapeutic candidate recurrent glioblastoma patients, was selected for an e-poster presentation at The European Society for Medical Oncology Virtual Congress 2020.
May 6, 2020 - Based upon a review of safety data from the first three patients enrolled, the independent Data and Safety Monitoring Board (DSMB) unanimously recommended continuing Phase 2a VBI-1901 + AS01B study arm without modification.
March 3, 2020 - VBI provided an update on Part A of the ongoing Phase 1/2a study of VBI-1901, the cancer vaccine immunotherapeutic candidate, to treat patients with recurrent glioblastoma. For patients who had an immunologic response to the vaccine, considered to be vaccine responders, the 12-month overall survival (OS) rate was 83% (n=5/6), compared to 33% for vaccine non-responders (n=3/9). Similarly, among patients evaluable for response and survival in Part A, vaccine responders saw a 6.25-month improvement in median OS (14.0 months) compared to vaccine non-responders (7.75 months). VBI-1901 continues to be safe and well-tolerated at all doses tested, with no safety signals observed.
VBI-1901 Clinical Trials
To learn more about VBI's ongoing Phase 1/2a study and the INSIGhT trial, visit clinicaltrials.gov (Respective Identifiers: NCT03382977 and NCT02977780).
Clinical Trial NCT03382977: Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects. This is a two-part dose-escalation study to define the safety, tolerability, and optimal dose level of candidate GBM vaccine VBI-1901 with subsequent extension of optimal dose level in recurrent GBM subjects.
