WuXi AppTec Content Team Editor
AlloVir recently announced that its multivirus-specific T cell therapy posoleucel has received FDA Regenerative Medicine Advanced Therapy Designation (RMAT) for use in patients receiving allogeneic hematopoietic cells Prevention of infection and disease caused by 6 devastating viruses in high-risk adult and pediatric patients after transplantation (allo-HCT). This is the third regenerative medicine advanced therapy designation granted by the FDA to posoleucel, underscoring the therapy’s potential to address the significant unmet medical need faced by immunocompromised allo-HCT patients, the press release noted.
Posoleucel is used to prevent the six viruses: adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) , human herpesvirus 6 (HHV-6) and JC virus (JCV). Since 90% of allo-HCT patients are infected with at least one of these viruses activating, the number of patients affected by these devastating viruses is high worldwide. With an estimated potential of 40,000 allo-HCT patients requiring treatment each year, there is a huge unmet medical need.
Patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation have their immune systems often suppressed or eliminated to prevent rejection of the transplanted cells or organs, leaving the patient extremely vulnerable to A devastating viral infection or disease occurs and can lead to end-organ damage and death. Conditioning regimens for transplantation often require complete elimination of the patient’s own stem cells, leaving the patient without a functioning immune system and severely immunocompromised after HSCT. Posoleucel is a multi-virus-specific allogeneic T cell targeting 6 viral pathogens, which plays an important role in providing immune system regulation, rebuilding bridging immunity, and can significantly reduce or prevent virus-related morbidity and mortality, improving patient outcomes.
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The new regenerative medicine advanced therapy designation is based on initial data from an open-label Phase 2 clinical trial evaluating the potential of posoleucel to prevent six virus-activated infections after allo-HCT. Preliminary data from the study were presented at the 48th European Society of Blood and Marrow Transplantation (EBMT) annual meeting in March this year. Of the 24 patients who reached the primary endpoint assessment at Week 14, 21 patients had no clinically significant infection. Repeated dosing was well tolerated. Final results from the Phase 2 clinical trial study are expected by the end of this year.
“Posoleucel’s three regenerative medicine advanced therapy designations reflect the potential of the AlloVir multiviral platform to both provide immunocompromised patients with important The viral prevention approach transforms the management of allo-HCT patients,” said Dr. Ercem Atillasoy, Chief Regulatory and Safety Officer, AlloVir.
References:
1. Posoleucel (Viralym-M, ALVR105): A multi-virus specific T cell therapy (VST) targeting five devastating viral pathogens. Retrieved April 22, 2022 from https:https:// www.allovir.com/products/alvr105
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