Efficacy of MAU868, a Novel BKV Neutralizing Monoclonal Antibody (mAb), for the Treatment of Severe BK Virus Nephropathy (BKVN) After Kidney Transplant
1Comprehensive Transplant Center, Cedars Sinai Medical Ctr, West Hollywood, CA, 2Comprehensive Transplant Center, Cedars Sinai Medical Ctr, Los Angeles, CA, 3Cedars Sinai Medical Ctr, Los Angeles, CA, 4Novartis Institutes for BioMedical Research, Virology Research, Emeryville, CA, 5Amplyx Pharmaceuticals, San Diego, CA, 6Novartis Institutes for BioMedical Research, Translational Medicine, East Hanover, NJ
Meeting: 2021 American Transplant Congress
Abstract number: 271
Keywords: Antibodies, Efficacy, Kidney, Post-operative complications
Topic: Clinical Science » Infectious Disease » Kidney: Polyoma
Session Information
Session Name: BK virus in Kidney Recipients
Session Type: Rapid Fire Oral Abstract
Date: Monday, June 7, 2021
Session Time: 6:00pm-7:00pm
Presentation Time: 6:30pm-6:35pm
Location: Virtual
*Purpose: BKV reactivation leading to nephropathy and allograft loss in kidney transplant (KT) recipients remains a clinical significant concern. No specific or effective anti-BKV therapies exist. Clinical management involves reduction of immunosuppression (IS), which increases the risk of acute graft rejection. MAU868 is a novel, human mAb (IgG) directed against the major BK viral capsid protein, VP1. In vitro, MAU868 potently neutralizes all 4 major BKV genotypes, has a high barrier-to-resistance and a long half-life (range 23-30 days). Data are presented from the first 2 patients with BKVN treated with MAU868, under separate single patient expanded access programs.
*Methods: Patient 1 is a 31 YO female with ESRD due to SLE and on HD for 3 yrs, underwent A2→B pediatric en-bloc DDKT. Patient 2 is a 67 YO male with history of idiopathic pulmonary fibrosis who underwent his second KT after the first was lost to BKVN. BK viremia developed in both patients and persisted despite IS reduction and treatment with IVIG. Patient 1 had biopsy-confirmed BKVN.
*Results: Patient 1 initially received 3 IV doses of MAU868 20 mg/kg monthly. The sCr and BK viremia decreased from 2.4 to 1.6 mg/dl and by 1.0 log10 copies/ml, respectively. Biopsy also showed improvement in BKVN. Eight additional doses of 20 mg/kg were administered biweekly with no further improvements. More than 2 yrs PT, BK viremia remained <104 log10 copies/mL, sCr was 3.0 mg/dl and dialysis has not been required. Patient 2 received 5 IV doses of MAU868 20 mg/kg monthly with sCr and eGFR remaining stable (~60 ml/min/1.73m2). BK viremia decreased by 1.0 log10 copies/ml and is <103 log10 copies/ml 4 months after the last dose. MAU868 was safe and well-tolerated in both patients.
*Conclusions: MAU868 treatment of 2 patients with active BKVN was associated with viral load reductions and improvement or stabilization of renal function. The clinical utility of MAU868 for the prevention and/or treatment of BKV disease warrants further clinical investigation in randomized, controlled clinical trials because the medical need for a specific anti-BKV therapy remains unmet and the experiences reported here suggest benefit is possible.
To cite this abstract in AMA style:
Jordan SC, Ammerman N, Toyoda M, Lim K, Abend JR, Patick A, Hodges MR, Vo A, Kovacs SJ. Efficacy of MAU868, a Novel BKV Neutralizing Monoclonal Antibody (mAb), for the Treatment of Severe BK Virus Nephropathy (BKVN) After Kidney Transplant [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/efficacy-of-mau868-a-novel-bkv-neutralizing-monoclonal-antibody-mab-for-the-treatment-of-severe-bk-virus-nephropathy-bkvn-after-kidney-transplant/. Accessed May 16, 2025.« Back to 2021 American Transplant Congress