Repeat administration of posoleucel was generally well tolerated, with balanced safety across posoleucel dosing groups and placebo
In Week 24 efficacy analysis, 39% (15/38) of patients who received posoleucel experienced a ≥1-log viral load reduction, more than double the placebo rate (14%; 2/14)
Posoleucel dose response was observed, with a ≥1-log viral load reduction in the biweekly dosing group of 50% (10/20) vs. 28% (5/18) in the monthly dosing group and 14% (2/14) in the placebo group
In the high viral load stratum (≥10,000 copies/mL), 69% (11/16) of patients who received posoleucel overall and 75% (6/8) of patients in the biweekly dosing group, achieved a ≥1-log viral load reduction vs. 25% (1/4) of patients in the placebo group
First demonstration of therapeutic potential of posoleucel for solid organ transplant patients
Company to host investor webcast at 9:00 a.m. EST today including Anil K. Chandraker, M.D., Director of Renal Transplant Medicine, Brigham & Women’s Hospital
WALTHAM, Mass.--(BUSINESS WIRE)-- AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today announced positive 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 (BKV) in adult kidney transplant recipients. The data support the safety and antiviral activity of posoleucel in this population, which has no effective BKV treatment options. In the randomized, double-blind, placebo-controlled study, posoleucel was shown to be generally well tolerated, with balanced safety across the two posoleucel dosing groups and placebo. Patients who received posoleucel achieved a clinically meaningful greater decline in BK viral load compared with those receiving placebo. The study results showed an even greater antiviral effect with posoleucel in patients with BK viral load ≥10,000 copies/mL at screening and in the biweekly posoleucel dosing group, identifying a dosing regimen and patient population to advance into a future trial.
"BKV is one of the most feared transplant-associated viral infections, due to the lack of available effective antiviral therapies and its profoundly negative impact on transplant outcomes,” said Anil K. Chandraker, M.D., Director of Renal Transplant Medicine, Brigham and Women's Hospital, and principal investigator of the posoleucel BKV treatment study. "The safety profile of posoleucel and its antiviral activity, which is amplified in high viral load patients who have the greatest unmet need, suggest it could potentially offer a transformative treatment option for kidney transplant patients with BK viremia.”
"This study is the first to evaluate a virus-specific T cell therapy in solid organ transplant patients, with the primary goal of exploring the safety of posoleucel treatment for BK viremia in kidney transplant patients. We are pleased with the consistency of posoleucel’s safety profile across solid and stem cell transplant patient populations and with the important antiviral efficacy results in kidney transplant patients at highest risk for BKV-associated graft loss observed in this study," said Diana Brainard, M.D., CEO, AlloVir. “We believe today's results are an important and compelling milestone not just for AlloVir but for the entire kidney transplant community."
Dr. Brainard continued, “These safety and efficacy data in solid organ transplant patients provide important insights into the potential of posoleucel, which is also being studied in our three ongoing Phase 3 registrational trials in allo-HCT patients. We look forward to working with regulatory authorities and transplant specialists on our forward-looking clinical development strategy in kidney transplant patients, and potentially other solid organ transplant recipients."
This Phase 2 study evaluated the safety and efficacy of posoleucel to treat BK viremia in adult kidney transplant recipients with BK viral load between 350-10,000,000 copies/mL (stratified by low (