Thursday, December 02, 2021 7:29:13 AM
Stocks mentioned: VBIV, GSK
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VBI Vaccines Inc (NASDAQ: VBIV) has presented updated 12-month and 18-month overall survival (OS) data from the Phase 2a study of VBI-1901, the Company's recurrent glioblastoma (GBM) vaccine
VBI-1901 + granulocyte-macrophage colony-stimulating factor (GM-CSF) arm showed 18-month OS of 30% (n=3/10)
One patient is still on protocol past week 86, with a 93% tumor reduction relative to initiation of treatment at the beginning of the study.
Two additional patients achieved OS of at least 20 months but are no longer on the protocol.
VBI-1901 + GlaxoSmithKline Plc's (NYSE: GSK) AS01 adjuvant system arm showed 12-month OS of 70% (n=7/10) and 18-month OS not yet reached.
Historical control data have demonstrated OS to be around 60% at 6-months and about 30% at 12-months after treatment with a monotherapy.
VBI expects to assess VBI-1901 in randomized, controlled clinical studies in both primary and recurrent GBM patients.
The Company plans to start enrollment of patients with recurrent GBM in Q1 2022.
Beginning mid-year 2022, VBI expects to evaluate VBI-1901 in INSIGhT Phase 2 adaptive platform trial with primary GBM.
Also see: FDA Approves VBI Vaccines' 3-Antigen Hepatitis B Vaccine.
Price Action: VBIV shares are down 7.69% at $2.88 during the premarket session on the last check Thursday.
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- Form 8-K - Current report • Edgar (US Regulatory) • 02/14/2024 01:34:40 PM
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