- New immunologic and biomarker data from Part A of ongoing Phase 1/2a clinical study of VBI-1901 in recurrent glioblastoma (GBM) patients strengthens correlation between observed vaccine and tumor responses
- New preclinical data further broadens utility of VBI’s enveloped virus-like particle (eVLP) platform technology in the oncology setting
VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will present new immuno-oncology data in a presentation titled, “eVLPs as an Antigen Delivery & Immunomodulatory Platform in Cancer,” at the World Vaccine Congress Europe to be held October 29-31, 2019, in Barcelona.
During his presentation, Dr. Anderson will discuss new immunologic and biomarker data from Part A of the ongoing Phase 1/2a clinical study of VBI-1901, VBI’s vaccine immunotherapeutic candidate, in patients with recurrent glioblastoma (GBM). 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. New assays now demonstrate that in these three vaccine responders, the frequency of harmful, immunosuppressive regulatory T-cells (Tregs) decreases over time, which also correlates with increases of beneficial CD4+ T-helper cells against both antigens contained in VBI-1901, glycoprotein B (gB) and pp65. These expanded biomarkers will also be used to assess responses of patients enrolled in Part B of the study, initial data from which are expected later this year. Download Presentation PDF“We are encouraged by the data we’ve seen to-date in Part A of the study, but also recognize that in early immuno-oncology clinical studies it is critical to establish a correlation between vaccine responses and observed tumor and clinical responses,” said Dr. Anderson. “This new immunologic and biomarker data further strengthens early activity observed thus far with VBI-1901 and we look forward to seeing the initial data from Part B of the study.”
Dr. Anderson will also discuss preclinical data that supports a broader utility of VBI’s proprietary enveloped virus-like-particle (eVLP) platform technology in oncology.
- Event: World Vaccine Congress Europe 2019
- Location: Palau de Congressos de Catalunya, Barcelona, Spain
- Date: Tuesday, October 29, 2019
- Time: 5:15 PM CET
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 38 patients with recurrent GBM:
- Part A:
- Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 in recurrent GBM patients with any number of prior recurrences
- This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0µg
- Enrollment completed December 2018
- Part B:
- Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase
- This phase will be a two-arm study, enrolling 10 patients in each arm, assessing VBI-1901 in combination with either GM-CSF or AS01B as immunomodulatory adjuvants
- Part B will enroll first-recurrent GBM patients only
VBI-1901 is administered intradermally when adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), and will be administered intramuscularly when adjuvanted with GSK proprietary AS01B adjuvant system. Patients in both phases of the study will receive the vaccine immunotherapeutic every four weeks until clinical progression.
Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.