Vaccine Info

VBI-1901 Glioblastoma (GBM) Cancer Vaccine

VBI-1901 Cancer Vaccine Description

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. VBI-1901’s goal is to boost the immune response to them. It boosts 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 the VBI Vaccines, Inc.

VBI has applied its eVLP Platform in the development of a glioblastoma multiforme therapeutic vaccine candidate. With its novel approach, VBI intends to create a GBM immunotherapy that will stimulate the patient’s own immune system to identify and kill GBM cancer cells, with the goal of creating 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 that can kill tumor cells with these antigens. VBI-1901 also includes a protein called granulocyte-macrophage colony-stimulating factor that gives the vaccine more punch.

GBM is among the most common and aggressive malignant primary brain tumors 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. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal, says the company.

VBI Vaccines Inc. is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.

VBI-1901 Cancer Vaccine Indication

VBI-1901 is an immunotherapy cancer vaccine that will stimulate the patient’s own immune system to identify and kill GBM cancer cells.

VBI-1901 Cancer Vaccine Condition

CMV is a common virus that infects people of all ages. Over half of adults have been infected with CMV by age 40. Most people infected with CMV show no signs or symptoms. When a baby is born with cytomegalovirus infection, it is called congenital CMV. About one out of every 200 babies is born with congenital CMV infection.  About one in five babies with congenital CMV infection will have long-term health problems.

VBI-1901 Cancer Vaccine Dosage

VBI-1901 is co-administered with GM-CSF via the intradermal route. 

February 2020: Dosing of the 10 patients in the VBI-1901 + GSK’s AS01B adjuvant system study arm began.

VBI-1901 Vaccine Updates

  • September 14, 2020 - VBI Vaccines Inc. announced that it's abstract highlighting additional biomarker data from the ongoing Phase 1/2a study of VBI-1901, the company’s cancer vaccine immunotherapeutic candidate, in 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 continuation of the 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 company’s cancer vaccine immunotherapeutic candidate, for the treatment of 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

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. Last updated on May 20, 2020.

  • Part A: Dose-escalation phase to define the safety, tolerability, and optimal dose level of VBI-1901 in recurrent GBM patients. This phase is expected to enroll up to 18 patients in three dose cohorts.
  • Part B: A subsequent extension of the optimal dose level, as defined in the dose-escalation phase. This phase is expected to enroll an expanded cohort of approximately 10 additional patients.
  • Mid-year 2020: Expanded immunologic, tumor, and clinical data expected from the Phase 2a VBI-1901 + GM-CSF study arm.
  • Q4 2020: Initial immunologic and tumor response data expected
Updated
09/19/2020 - 20:38