▎ WuXi AppTec content team editor
Recently, AlloVir announced that its multivirus-specific T cell therapy potsoleucel has been recognized by the FDA as an advanced therapy for regenerative medicine (RMAT) for the prevention of infections and diseases caused by 6 destructive viruses in high-risk adult and pediatric patients after receiving allogeneic hematopoietic cell transplantation (allo-HCT). The press release notes that this is the third FDA-granted claim to potoleucel as an advanced therapy for regenerative medicine, highlighting the potential of the therapy to address the significant unmet medical needs faced by immunocompromised allo-HCT patients.
Posoleucel is used for prevention of 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 by at least one of these viruses, the number of patients affected by these damaging viruses is large worldwide. An estimated 40,000 potential allo-HCT patients need treatment each year, and there is a huge unmet medical need.
The immune system of patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation is usually suppressed or eliminated to prevent rejection of transplanted cells or organs, which makes patients extremely susceptible to destructive viral infections or diseases and can lead to end-organ damage and death. Transplant pretreatment protocols often require the complete elimination of the patient's own stem cells, leaving the patient without a functioning immune system after HSCT and in a severely immunocompromised state. Posoleucel is a multiviral-specific allogeneic T cell that targets 6 viral pathogens, plays an important role in providing immune system regulation, rebuilding bridging immunity, and can significantly reduce or prevent virus-related morbidity and mortality, and improve patient outcomes.
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The new Advanced Therapies in Regenerative Medicine were identified based on initial data from an open-label Phase 2 clinical trial that assessed the potential of posoleucel to prevent six viral-activating infections after allo-HCT. Preliminary data for the study were presented at the 48th annual meeting of the European Society for Blood and Bone Marrow Transplantation (EBMT) in March this year. Of the 24 patients assessed at week 14 who met the primary endpoint at week 14, 21 did not develop clinically significant infections. Repeated administration is well tolerated. The final results of the Phase 2 clinical trial study are expected to be published by the end of this year.
"Posoleucel's three regenerative medicine advanced therapies identification reflects the potential of the AlloVir multivirus platform, which can both provide immunocompromised patients with important treatment options that were not previously available, or can change the management of allo-HCT patients through a multiviral prevention approach." Dr. Ercem Atillasoy, AlloVir's chief regulatory and safety officer, said.
Resources:
1. Posoleucel (Viralym-M, ALVR105): A multi-virus specific T cell therapy (VST) targeting five devastating viral pathogens. Retrieved April 22, 2022 from https://www.allovir.com/products/alvr105
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