AlloVir Gets FDA Regenerative Medicine Advanced Therapy Designation for Posoleucel

By Michael Dabaie

AlloVir Inc. said the U.S. Food and Drug Administration granted its lead multi-virus specific T cell therapy posoleucel Regenerative Medicine Advanced Therapy designation.

The designation is for the treatment of adenovirus infection following allogeneic hematopoietic stem cell transplant and is based on results from a Phase 2 study.

RMAT designation recognizes the potential for posoleucel to address the unmet medical need posed by AdV, a potentially life-threatening condition with no approved treatment options, the late-clinical stage company said.

This designation enables early interactions with the FDA to discuss clinical trial design and other actions to expedite development and review.

The FDA previously granted RMAT designation to posoleucel for the treatment of hemorrhagic cystitis caused by BK virus in adults and children following allo-HCT.

A Phase 3 study of posoleucel for the treatment of AdV viremia is now enrolling pediatric and adult patients following allo-HCT. This study is the second Phase 3 registrational study of posoleucel.

The company also said it initiated a Phase 1/2 clinical trial of ALVR106 for the treatment of infections caused by human metapneumovirus, influenza, parainfluenza virus and respiratory syncytial virus.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

January 05, 2022 08:06 ET (13:06 GMT)

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