VBI Vaccines Inc. (NASDAQ:VBIV) has announced that it will present updated data of Part B of its ongoing Phase 1/2a VBI-1901 study at the Virtual Annual American Association for Cancer Research summit. VBI-1901 is the company’s immunotherapeutic cancer vaccine candidate for the treatment of recurrent glioblastoma (GBM).
VBI report encouraging phase1/2a VBI-1901 data
Data from the study indicated that GBM patients with a baseline CD4+/CD8+ T-Cell ratio are likely to show tumor reduction or delayed progression, which is shown as tumor response. So far, to date, there have been five out of six tumor responses shown, which include a recent partial response. This is defined as over 50% tumor response according to the Response Assessment in Neuro-Oncology criteria. This suggests that the biomarker can predict patients that are likely to respond as well as get clinical benefit from VBI-1901 treatment.
Based on data observed to date, the company is exploring a controlled, randomized registration trial for the next development phase, which subject to regulatory approval could commence next year. Equally, the company continues enrolment of the Part B Phase 1/2a VBI-1901 study in combination with GlaxoSmithKline’s AS01B adjuvant and tumor, and immunologic data will be out in Q4 2020.
VBI keen on advancing VBI-1901 as a viable GBM treatment option
The company’s Chief Scientific Officer David Anderson indicated that the CD4+/CD8+ T-C ratio identification as a possible predictive biomarker and the recently established partial response, are encouraging developments. Anderson stated that so far, there have been promising results from the VBI-1901 Phase1/2a clinical study. He added that the CD4+/CD8+ ratio may show CD4+ T-Cell’s immunologic fitness in recurrent GBM patients. Therefore it might be used in the next clinical development phase in identifying patients that are likely to respond to VBI-1901.
Most importantly, testing of CD4+/CD8+ T-cell ratio in the biomarker strategy can use a common assay that can easily be implemented via treatment settings. The chief scientific officer confirmed that the company is working to advance BI-1901 as a viable treatment for patients with GBM who have limited treatment options.