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VBI Vaccines (VBIV) Up on Glioblastoma Drug Fast Track Status
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VBI Vaccines Inc. (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 - 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.
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.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Image: Bigstock
VBI Vaccines (VBIV) Up on Glioblastoma Drug Fast Track Status
VBI Vaccines Inc. (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%.
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 - 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.
VBI Vaccines, Inc. Price
VBI Vaccines, Inc. price | VBI Vaccines, Inc. Quote
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 - Free Report) and Repligen Corporation (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.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How to Profit from Trillions on Spending for Infrastructure >>