AlloVi announced that the U.S. Food and Drug Administration (FDA) has granted its lead multi-virus specific T cell (VST) therapy, posoleucel (Viralym-M, ALVR105), Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of adenovirus (AdV) infection following allogeneic hematopoietic stem cell transplant (allo-HCT). The designation is based on positive results from the Phase 2 CHARMS 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.

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 (HC) caused by BK virus in adults and children following allo-HCT. A Phase 3 registrational study (NCT05179057) of posoleucel for the treatment of AdV viremia is now open and enrolling pediatric and adult patients following allo-HCT.

This study is the second Phase 3 registrational study of posoleucel, following the initiation of the Phase 3 study for the treatment of virus-associated HC last year. Separately, the company also announced the initiation of a Phase 1/2 clinical trial (NCT04933968) of ALVR106, its investigational, allogeneic, off-the-shelf, multi-VST therapy for the treatment of infections caused by human metapneumovirus (hMPV), influenza, parainfluenza virus (PIV) and respiratory syncytial virus (RSV). This trial extends AlloVir's VST platform to tackle respiratory viruses that pose a considerable risk for autologous and allo-HCT patients.