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AlloVir (ALVR) Begins Study to Prevent Six Viral Infections
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AlloVir, Inc. (ALVR - Free Report) announced that it has initiated a phase III study evaluating its allogeneic, off-the-shelf, multi-virus-specific T-cell therapy, posoleucel, which is being developed for addressing life-threatening viral infections from six common viruses in high-risk allogeneic hematopoietic cell transplant (allo-HCT) patients.
The registrational study will investigate posoleucel for the prevention of clinically significant infections and end-organ diseases from six viruses, namely, adenovirus (AdV), BK virus (BKV), cytomegalovirus, Epstein-Barr virus, human herpesvirus-6 (HHV-6) and JC virus – in the given patient population.
Shares of AlloVir were up 7.3% following the announcement of the news on Tuesday. The ALVR stock has dipped 37.1% so far this year compared with the industry’s decline of 13.8%.
Image Source: Zacks Investment Research
Per the company, the double-blind, placebo-controlled study will evaluate posoleucel by checking the number of clinically significant infections or episodes of end-organ disease through the primary endpoint of the 14-week dosing interval in adult and pediatric patients.
AlloVir has recently presented updated initial data from a phase II study on posoleucel at the annual meeting of the European Society for Blood and Marrow Transplantation. The data showed that treatment with posoleucel led to a substantial reduction in the expected rate of clinically significant infections.
Final data from the phase II study is expected by the end of 2022.
Posoleucel is AlloVir’s lead product candidate. The company is currently conducting three phase III studies on posoleucel in both the prevention and treatment of life-threatening viral infections with limited or no treatment options available.
The FDA has granted Regenerative Medicine Advanced Therapy designation to posoleucel for the treatment of hemorrhagic cystitis (“HC”) caused by BKV, and for the treatment of AdV infection in allo-HCT pateints. The regulatory body has also granted Orphan Drug designation to posoleucel for the treatment of virus-associated HC.
AlloVir currently has no approved product in its portfolio. Therefore, the successful development of posoleucel, along with other pipeline candidates, remains in key focus for the company.
Corbus Pharmaceuticals’ loss per share estimates have narrowed 38.9% for 2022 and 13.5% for 2023 over the past 60 days.
Earnings of Corbus Pharmaceuticals have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Gemini Therapeutics’ loss per share estimates have narrowed 64.9% for 2022 and 72.2% for 2023 over the past 60 days.
Earnings of Gemini Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Minerva Neurosciences’ loss per share estimates have narrowed 20.4% for 2022 and 19.7% for 2023 over the past 60 days.
Earnings of Minerva Neurosciences have surpassed estimates in one of the trailing four quarters, met the same once and missed the same on the other two occasions.
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AlloVir (ALVR) Begins Study to Prevent Six Viral Infections
AlloVir, Inc. (ALVR - Free Report) announced that it has initiated a phase III study evaluating its allogeneic, off-the-shelf, multi-virus-specific T-cell therapy, posoleucel, which is being developed for addressing life-threatening viral infections from six common viruses in high-risk allogeneic hematopoietic cell transplant (allo-HCT) patients.
The registrational study will investigate posoleucel for the prevention of clinically significant infections and end-organ diseases from six viruses, namely, adenovirus (AdV), BK virus (BKV), cytomegalovirus, Epstein-Barr virus, human herpesvirus-6 (HHV-6) and JC virus – in the given patient population.
Shares of AlloVir were up 7.3% following the announcement of the news on Tuesday. The ALVR stock has dipped 37.1% so far this year compared with the industry’s decline of 13.8%.
Image Source: Zacks Investment Research
Per the company, the double-blind, placebo-controlled study will evaluate posoleucel by checking the number of clinically significant infections or episodes of end-organ disease through the primary endpoint of the 14-week dosing interval in adult and pediatric patients.
AlloVir has recently presented updated initial data from a phase II study on posoleucel at the annual meeting of the European Society for Blood and Marrow Transplantation. The data showed that treatment with posoleucel led to a substantial reduction in the expected rate of clinically significant infections.
Final data from the phase II study is expected by the end of 2022.
Posoleucel is AlloVir’s lead product candidate. The company is currently conducting three phase III studies on posoleucel in both the prevention and treatment of life-threatening viral infections with limited or no treatment options available.
The FDA has granted Regenerative Medicine Advanced Therapy designation to posoleucel for the treatment of hemorrhagic cystitis (“HC”) caused by BKV, and for the treatment of AdV infection in allo-HCT pateints. The regulatory body has also granted Orphan Drug designation to posoleucel for the treatment of virus-associated HC.
AlloVir currently has no approved product in its portfolio. Therefore, the successful development of posoleucel, along with other pipeline candidates, remains in key focus for the company.
Zacks Rank & Stocks to Consider
AlloVir currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector are Corbus Pharmaceuticals Holdings, Inc. (CRBP - Free Report) , Gemini Therapeutics, Inc. and Minerva Neurosciences, Inc. (NERV - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Corbus Pharmaceuticals’ loss per share estimates have narrowed 38.9% for 2022 and 13.5% for 2023 over the past 60 days.
Earnings of Corbus Pharmaceuticals have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Gemini Therapeutics’ loss per share estimates have narrowed 64.9% for 2022 and 72.2% for 2023 over the past 60 days.
Earnings of Gemini Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Minerva Neurosciences’ loss per share estimates have narrowed 20.4% for 2022 and 19.7% for 2023 over the past 60 days.
Earnings of Minerva Neurosciences have surpassed estimates in one of the trailing four quarters, met the same once and missed the same on the other two occasions.