AlloVir, Inc. (NASDAQ: ALVR) is a late-stage clinical cell therapy company, which is focused on the research, development and commercialization of therapies to restore natural immunity against viral diseases. Shares of the cell therapy company are rallying 31% through early trading on Wednesday, April 20, 2022. Over the past three months, AlloVir has seen average daily volume of 276,440 shares. However, volume of 57.53 million shares or dollar volume of around $431.48 million, has already exchanged hands through early trading.
Shares of AlloVir are gaining after the company announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) Designation to the company’s T-cell therapy, posoleucel, for the prevention of life-threatening infections from six viruses that are common in patients following allogeneic hematopoietic cell (allo-HCT) transplants. The six viruses specifically identified in the RMAT include adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, human herpes virus-6, and JC virus.
The latest FDA grant represents the third RMAT designation for posoleucel, further validating the investigational drug’s strong potential in treating a significant unmet medical need. Previous RMAT grants for the investigational drug were for the treatment of hemorrhagic cystitis caused by the BK virus in allo-HCT patients and adenovirus infection from allo-HCT.
The latest RMAT designation was granted after initial data from AlloVir’s open-label Phase 2 study, which tested posoleucel as a treatment for serious infections caused by the six viruses from allo-HCT. Out of the 26 patients enrolled in the Phase 2 trial, only three patients had statistically significant infections through 14 weeks. Twenty-one of the twenty-four patients who had reached the Week 14 primary endpoint remained free of any significant infections. A global Phase 3 trial was initiated in March 2022 and is currently enrolling patients.
Ercem Atillasoy, M.D., Chief Regulatory and Safety Officer, AlloVir: “The receipt of three RMAT designations for a single therapy is unprecedented. Posoleucel’s three RMAT designations reflect the strength of AlloVir’s multi-virus platform and its potential both to deliver an important treatment option for immunocompromised patients who currently have none, and to transform the management of allo-HCT patients with a multi-virus prevention approach.”
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