AlloVir, a portfolio company of ElevateBio, became the latest company to announce it has received an RMAT designation from the U.S. FDA with its June 11, 2019 announcement. AlloVir’s lead allogeneic, off-the-shelf, multi-virus specific T-cell therapy, Viralym-M (ALVR105), received the designation.
Viralym-M is being developed to treat BK virus-associated hemorrhagic cystitis after hematopoietic stem cell transplantation (HSCT). It is a “ready-to-administer” single T-cell product that can treat six different viral infections at the same time.
According to the company, “Following positive Phase 2 clinical data published in the Journal of Clinical Oncology (Tzannou, JCO, 2017), AlloVir is in the process of planning Phase 3 registrational studies of Viralym-M.”