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AlloVir Announces Positive Final Results from Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Posoleucel in Kidney Transplant Recipients with BK Viremia
Repeat administration of posoleucel was generally well tolerated, with balanced safety across posoleucel dosing groups and placebo In Week 24 efficacy
About this update from Kalaris Therapeutics, Inc.
[{"type":"text","content":"\nRepeat administration of posoleucel was generally well tolerated, with balanced safety across posoleucel dosing groups and placebo\n\nIn 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)\n\nPosoleucel 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\n\nIn 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\n\nFirst demonstration of therapeutic potential of posoleucel for solid organ transplant patients\n\nCompany 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\n\n WALTHAM, Mass.--(BUSINESS WIRE)--\nAlloVir, 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.\n\n\"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 Tran...