FDA Grants Third RMAT Designation to AlloVir’s T Cell Therapy – Targeting Viruses in Allogeneic Hematopoietic Cell Transplant Patients
Late clinical-stage allogenic T cell immunotherapy company, AlloVir, has announced the FDA have granted RMAT designation to its multi-virus specific T cell therapy, posoleucel, for targeting six viruses commonly occurring in high-risk patients following allogenic hematopoietic cell transplant (allo-HCT).
This RMAT designation, the third granted to posoleucel as a treatment in patients post allo-HCT, comes following initial data form AlloVir’s open-label Phase II study, investigating posoleucel’s potential in preventing infections in allo-HCT patients from the life-threatening viruses – JC virus, human herpes virus-6, Epstein-Barr virus, cytomegalovirus, BK virus and adenovirus.
90% of all allo-HCR patients, in an estimated population of 40,000 people receiving this procedure annually, reactive one or more of these six viruses.
“The receipt of three RMAT designations for a single therapy is unprecedented. Posoleucel’s three RMAT designations reflect the strength of AlloVir’s multi-virus platform and its potential both to deliver an important treatment option for immunocompromised patients who currently have none, and to transform the management of allo-HCT patients with a multi-virus prevention approach,” said Ercem Atillasoy, Chief Regulatory and Safety Officer at AlloVir.
Data presented last month by AlloVir at the 48th Annual Meeting of the European Society for Blood and Marrow Transplantation reported that, after a period of 14 weeks, only 3 out of the 26 patients to receive at least one does of posoleucel experienced an infection of clinical significance from one or more of the above six viruses.
Over 90% of the patients receiving posoleucel, who had previously failed to respond to conventional treatment, demonstrated either partial or complete elimination of detectable virus in the blood.
Repeat dosing was observed as well tolerated amongst patients, with final results from this proof-of-concept CHARMS Phase II study to be expected by the end of 2022.
Additional to posoleucel’s previous FDA RMAT designations – granted for the treatment of BKV linked hemorrhagic cystitis and adenovirus in patients following allo-HCT – posoleucel has received FDA Orphan Drug Designation for the treatment of virus-associated HC, as well as EMA PRIority Medicines designation and Orphan Medicinal Product designation for the treatment of multiple viral diseases and infections.
Source: AlloVir Press Release