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VBI Vaccines Announces Positive DSMB Review in Phase 1/2a Study of VBI-1901 in Recurrent Glioblastoma (GBM) Patients
VBI Vaccines (Nasdaq:VBIV) a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that, upon review of all safety data from the fully enrolled, low-dose patient cohort of the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent Glioblastoma (GBM), the independent Data and Safety Monitoring Board (DSMB) unanimously recommended the continuation …
VBI Vaccines (Nasdaq:VBIV) a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that, upon review of all safety data from the fully enrolled, low-dose patient cohort of the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent Glioblastoma (GBM), the independent Data and Safety Monitoring Board (DSMB) unanimously recommended the continuation of the study without modification.
As quoted in the press release:
Following this recommendation, VBI has initiated enrollment in the intermediate-dose arm of the dose-escalation phase of this study. Two additional, pre-specified DSMB reviews will occur after the completion of enrollment in the intermediate-dose study arm and the high-dose study arm, respectively.
“We are encouraged by the safety profile of this candidate so far and are excited to continue enrollment in the intermediate dose cohort of this Phase 1/2a study, our first clinical study in immuno-oncology,” said Jeff Baxter, VBI’s president and CEO. “In recurrent GBM, a devastating CMV-associated tumor, patients have few effective treatment options, and we believe that VBI-1901 has the potential to stimulate immune responses critical to boosting anti-tumor immunity.”
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