AlloVir, Inc. announced the presentation of final results from a Phase 2 study of posoleucel, an investigational, allogeneic, off-the-shelf, multi-virus-specific T cell (VST) therapy, being studied for the treatment of BK viremia in adult kidney transplant recipients. The findings, presented at the American Transplant Congress (ATC 2023) in San Diego, CA, during a late-breaking oral abstract session (LB001), support the safety and antiviral activity of posoleucel in adult kidney transplant recipients with BK virus (BKV) infection. Currently, there are no effective treatment options for BKV infection.

Top line data were shared earlier this year. BKV infection poses a significant threat to kidney graft survival. Over 90,000 kidney transplants are currently performed each year globally, and the virus reactivates in up to 20% of these patients.

In patients who have reactivated BKV, a substantial portion will develop high-level viremia. Approximately half of those will develop BKV- associated nephropathy (BKVAN), which can lead to decreased kidney survival and a return to end-stage renal disease and dialysis. About the Phase 2 Study The Phase 2 study evaluated the safety and efficacy of posoleucel to treat BKV infection in adult kidney transplant recipients with plasma BK viral load between 350-10,000,000 copies/mL (stratified by low (<10,000 copies/mL) or high (>=10,000 copies/mL) viral load at study screening).

Consensus groups, including the American Society of Nephrology and the American Society of Transplantation, consider BK viral load of greater than or equal to 10,000 copies/mL to be presumptive BKVAN. The primary endpoint of the study was the safety and tolerability of posoleucel versus placebo, and the secondary endpoint of the study was the change in BK viral load in patients receiving posoleucel versus those receiving placebo. Top line results from this study were shared earlier this year.