Phase III trials suspended for T-cell therapeutic active against HHV-6

Allovir has discontinued its three Phase III trials on posoleucel, an infusion therapy intended to prevent clinically significant infections in transplant patients.  The “off the shelf” donor T cells were primed to combat five common viral pathogens: HHV-6, EBV, CMV, BK virus and adenovirus. Posoleucel (formerly known as Viralym M) was the only therapeutic in development in the US market to address HHV-6 infection.

Ann Leen, PhD, Professor of Pediatrics at Baylor College of Medicine and Center for Cell and Gene Therapy, served as Allovir’s Co-Founder and Chief Scientific Officer.

The results were a surprise since the Phase II results showed a 92% partial or complete response rate (Tzannou 2017). The trials were ended early when the independent review panels for each of the three studies concluded that the trials were unlikely to meet their primary endpoints. No safety concerns were raised.

The therapy was pioneered by co-founder and scientific director Ann Leen, PhD, a professor at the Center for Cell and Gene Therapy at the Baylor College of Medicine,

The company raised $350 million to develop the cells and the company was valued at $1.1 billion when it went public in 2020.

The company’s press release stated that they will continue to develop T cell therapies for other conditions including BK virus in kidney patients and multi-virus therapy for respiratory infections.