VBI Vaccines to Present Initial Data for VBI-1901 in Recurrent Glioblastoma (GBM) Patients at the 2018 Annual Meeting of the Society for Neuro-Oncology (SNO)
October 24, 2018 | Conferences, Glioblastoma ("GBM"), Posters, Press Releases
VBI Vaccines Inc. (NASDAQ: VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that initial clinical data from the Phase 1/2a study of VBI-1901 in recurrent Glioblastoma (GBM) patients will be presented in a poster discussion session at the 23rd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), taking place November 15-18, 2018, in New Orleans, Louisiana.
“While early, the responses we’ve seen to-date are encouraging,” said David Anderson, Ph.D., VBI’s Chief Scientific Officer. “The data to be presented at SNO will assess initial immunologic responses to vaccination with VBI-1901 in patients with recurrent GBM. We’ve already seen evidence of robust boosting of CMV-specific immunity directed against multiple antigens in some subjects in both the low and intermediate dose cohorts. As this is the first clinical data from our immuno-oncology vaccine candidate, we are honored and very pleased that the SNO has accepted our abstract for poster presentation and we look forward to the meeting.”
Following two positive Data Safety and Monitoring Board reviews that occurred in April and September 2018, detailed patient-specific data for subjects in the low- and intermediate-dose cohorts will be included in the presentation. Additional information will be available when abstracts are released from embargo on November 5th, 2018.
The SNO Poster Discussion session presentation details are as follows:
- Title: CMV gB/pp65 eVLPs Formulated with GM-CSF as a Therapeutic Vaccine Against Recurrent Glioblastoma (GBM)
- Poster Number: ATIM-14
- Date: Friday, November 16, 2018
- Time: 7:30 PM – 9:30 PM CDT
- Location: Marriott Hotel, New Orleans, Louisiana
About the Phase 1/2a Study Design
VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 28 patients with recurrent GBM:
- 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.
VBI-1901 is administered intradermally and is adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), a potent adjuvant that mobilizes dendritic cell function. Patients in both phases of the study will receive vaccine every four weeks until tumor progression.
Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.
About VBI Vaccines⌃
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 Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
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