VBI Vaccines Inc. announced that new tumor response and overall survival (OS) data from the ongoing phase 2a study of VBI-1901, the company's cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) was presented at the 2022 american society of clinical oncology (ASCO) annual meeting on June 5, 2022. The expanded phase 2a data were selected for presentation in both a poster session and a poster discussion session. VBI-1901 + GM-CSF study arm ­ high dose part A + part B (n=16).

Two partial tumor responses and five stable disease seen across part A and part B. 18-month overall survival (OS) of 25% (n=4/16). Median OS (mOS) reached at 12.9 months, comparing favorably to 8-month mOS for standard-of-care1. One patient remains on protocol beyond two years, with a 93% tumor reduction relative to initiation of treatment at the beginning of the study ­ this reduction has been sustained for over 6 months.

VBI-1901 + GSK's AS01B adjuvant system2 (n=10). Five stable disease observed 18-month overall survival (OS) of 40% (n=4/10). Achieved mOS of 14.6 months, comparing favorably to 8-month mOS for standard-of-care1.

With few effective treatment options available for recurrent GBM patients, historical control data have demonstrated OS to be ~60% at 6-months and ~30% at 12-months after treatment with a monotherapy. This dataset continues to build upon data first shared at ASCO 2021, which resulted in fast track designation granted by the U.S. food and drug administration (FDA) in June 2021, and then updated at the world vaccine & immunotherapy congress in December 2021. Next Steps for VBI-1901 based on the data seen to date in the phase 1/2a study in recurrent GBM patients, VBI expects to assess VBI-1901 in randomized, controlled clinical studies in both primary and recurrent GBM patients in the next phase of development: third quarter 2022: Expected initiation of next phase of development in recurrent GBM setting, aiming to expand the number of patients in the ongoing phase 1/2a study and adding a control arm, with the potential for accelerated approval based on tumor response rates and improvement in overall survival.

Fourth quarter 2022: Evaluation of VBI-1901 in the primary GBM setting expected to initiate as part of the Individualized screening trial of Innovative glioblastoma therapy (INSIGhT), a phase 2 adaptive platform trial.