RMAT for posoleucel: good news for AlloVir’s T-cell-based therapy for post-stem cell transplant adenovirus infection
AlloVir (MA, USA) has announced their investigational T-cell-based therapy, posoleucel, has been granted a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of post-allogeneic hematopoietic stem cell transplant (HCT) adenovirus infection (AdV). This is the second RMAT for conditions related to allogeneic HCT for posoleucel, which was previously designated RMAT for the treatment of BK virus-induced hemorrhagic cystitis.
AdV occurs in approximately one third of pediatric patients receiving allogeneic HCT and can cause disease ranging from mild gastroenteric or respiratory symptoms to multi-organ failure and death. However, there are currently no approved treatment options. This latest RMAT was awarded following promising results at phase II.
“We are pleased that the FDA has granted posoleucel RMAT designation for a second treatment-related indication,” commented Ercem Atillasoy, 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.”
A phase III trial for posoleucel for AdV is currently enrolling pediatric and adult patients with high-level viremia and/or immune deficiency, and will assess how posoleucel reduces the viral load.