Business
FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to AlloVir’s Posoleucel for the Treatment of Adenovirus (AdV) Infections in Adults and Children Post-Allogeneic Stem Cell Transplantation
Treatment of AdV infection is posoleucel’s second potential indication to receive RMAT designation Phase 3 registrational study of posoleucel for AdV
About this update from Kalaris Therapeutics, Inc.
[{"type":"text","content":"\nTreatment of AdV infection is posoleucel’s second potential indication to receive RMAT designation\n\nPhase 3 registrational study of posoleucel for AdV treatment is now open for enrollment\n\nProof-of-concept study of ALVR106 for the treatment of multiple respiratory viral infections is also open for enrollment\n\n WALTHAM, Mass.--(BUSINESS WIRE)--\nAlloVir, a late-clinical stage allogeneic T-cell immunotherapy company, today 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.\n\nRMAT 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.\n\n“We are pleased that the FDA has granted posoleucel RMAT designation for a second treatment-related indication,” said Ercem Atillasoy, M.D., Chief Regulatory and Safety Officer, AlloVir. “The two RMAT designations reinforce the potential of posoleucel in areas of urgent patient need. We look forward to working closely with FDA as we continue to advance posoleucel through late-stage clinical development.”\n\nA 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.\n\nSeparately, 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)...