VBI Vaccines Inc. ( VBIV Quick Quote VBIV - Free Report) announced that the FDA has granted Fast Track designation to its cancer vaccine immunotherapeutic candidate, VBI-1901. A phase I/IIa study is evaluating the candidate as a potential treatment of recurrent glioblastoma (GBM) patients.
Notably, the FDA provides a Fast Track designation to help the development and faster review of drugs, which treat serious and unmet medical conditions.
Shares of VBI Vaccines were up 14.5% on Tuesday following the announcement of the news. In fact, the stock has rallied 44% so far this year against the
industry’s decrease of 1.1%. Image Source: Zacks Investment Research
We remind investors that the company has completed the phase I portion of the phase I/IIa study evaluating VBI-1901 and initiated the phase IIa portion in July 2019 with 10 microgram dose of the candidate. This portion is evaluating the candidate adjuvanted with granulocyte macrophage colony-stimulating factor (GM-CSF) or
Glaxo’s ( GSK Quick Quote GSK - Free Report) adjuvant, AS01, in separate cohorts.
Please note that the FDA granted the designation to VBI-1901, adjuvanted with GM-CSF, for treating first-recurrent GBM.
Updated interim data from the study has shown that treatment with VBI-1901 plus GM-CSF achieved overall survival (OS) of 80% and 60% at six month and 12 month, respectively, following initiation of treatment. The candidate plus AS01 achieved OS of 89% at 6 month. Historical control data demonstrates OS of nearly 60% and 30% at six-month and 12-month, respectively, following treatment with any monotherapy in recurrent GBM patients.
Clinical data on with VBI-1901 demonstrates its potential as a better treatment option for GBM patients.
Apart from VBI-1901, VBI Vaccines is developing several other therapeutic and vaccine candidates targeting multiple indications. Regulatory applications seeking approval for its hepatitis B vaccine candidate is under review in the United States and Europe. A decision from the FDA is expected by Nov 30, 2021. The vaccine has been approved in Israel since 2017. The company is also developing a therapeutic candidate for hepatitis B in a mid-stage study.
The company is also developing three different COVID-19 vaccine candidates in different stages of pre-clinical or clinical studies.
Zacks Rank and Stocks to Consider
VBI Vaccines currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks from the drug/biotech sector are
Bellerophon Therapeutics, Inc. ( BLPH Quick Quote BLPH - Free Report) and Repligen Corporation ( RGEN Quick Quote RGEN - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Bellerophon’s loss per share estimates have narrowed from $2.75 to $2.69 for 2021 and from $2.31 to $2.27s for 2022 in the past 30 days.
Repligen’s earnings per share estimates increased from $2.21 to $2.26 for 2021 and from $2.53 to $2.56 for 2022 in the past 30 days.
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