Express T cell therapy has been recognized by the FDA as an advanced therapy for regenerative medicine for the prevention of 6 kinds of viral infections

▎WuXi AppTec Content Team Editor Recently, AlloVir announced that its multi-virus-specific T cell therapy posoleucel has received FDA Regenerative Medicine Advanced Therapy Designation (RMAT) for high-risk adults after allogeneic hematopoietic cell transplantation (allo-HCT).
and pediatric patients, prevent infections and diseases caused by 6 devastating viruses
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This is the third regenerative medicine advanced therapy designation granted by the FDA to posoleucel, underscoring the therapy's potential to address a significant unmet medical need faced by immunocompromised allo-HCT patients, the press release noted
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 The six viruses that Posoleucel is used for prophylaxis are: adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), and human herpesvirus 6 (HHV-6) and JC virus (JCV)
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Since 90% of allo-HCT patients are infected with at least one of these viruses, the number of patients affected by these devastating viruses is high worldwide
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With an estimated potential 40,000 allo-HCT patients requiring treatment each year, there is a huge unmet medical need
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The immune system of patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation is often suppressed or eliminated to prevent rejection of the transplanted cells or organs, which makes the patient highly susceptible to devastating viral infections or diseases and may lead to end-organ damage and death
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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
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Posoleucel is a multi-virus-specific allogeneic T cell targeting 6 viral pathogens, which plays an important role in providing immune system modulation, rebuilding bridging immunity, and can significantly reduce or prevent virus-related morbidity and mortality , improve patient outcomes
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 Image credit: 123RF’s 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
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Preliminary data from the study were presented at the 48th European Society of Blood and Marrow Transplantation (EBMT) annual meeting in March this year
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Of the 24 patients who reached the primary endpoint assessment at Week 14, 21 patients had no clinically significant infection
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Repeated dosing was well tolerated
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Final results from the Phase 2 clinical trial study are expected by the end of this year
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"Posoleucel's three regenerative medicine advanced therapy designations reflect the potential of the AlloVir multiviral platform to both provide immunocompromised patients with important treatment options not previously available, and to transform the management of allo-HCT patients with a multiviral prophylaxis approach.

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said Dr Ercem Atillasoy, Chief Regulatory and Safety Officer at AlloVir
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References: 1.
Posoleucel (Viralym-M, ALVR105): A multi-virus specific T cell therapy (VST) targeting five devastating viral pathogens.
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