MAU868 / Pfizer, Vera Therap - LARVOL DELTA

Patient BK Polyomavirus VP1 Genotyping Predicts Neutralizing Antibody Incompatibility and Provides Guardrails for VP1-Targeting Monoclonal Antibody Trial and Therapy (KIDNEY WEEK 2025) - "Two VP1-targeting monoclonal antibodies (mAbs, MAU868 and Potravitug) failed to reduce viral load in Phase 2 trials...It demonstrates that the donor–recipient serology and BK VP1 genotype mismatch contributes to viral reactivation. Our model supports the following steps for Phase 2–4 design (i) baseline VP1 genotyping with compatibility stratification for study entry and clinical use; (ii) on–therapy VP1 sequencing (paired plasma/urine) to detect resistance."

Clinical • Late-breaking abstract

Non-clinical and clinical characterization of MAU868, a novel human-derived monoclonal neutralizing antibody targeting BK polyomavirus VP1. (PubMed, Am J Transplant) - "The pharmacokinetics of MAU868 was typical of a human IgG, with dose-proportional systemic exposure and an elimination half-life ranging between 23 and 30 days. These results demonstrate the potential of MAU868 as a first-in-class therapeutic agent for the treatment or prevention of BKPyV disease."

Journal • Hematological Disorders • Infectious Disease • Renal Disease • Transplantation

A Randomized Phase 2 Study of Mau868 vs Placebo for Bk Viremia in Kidney Transplant Recipients: Bk Viral Kinetics and Outcomes in Two Dosing Cohorts (ATC 2023) - "In this study , MAU868 exhibited a stronger antiviral effect versus placebo in KTRs with BK viremia and was well tolerated. A loading dose did not appear to increase response to therapy as measured by viral load in plasma and urine."

Clinical • P2 data • Transplantation

Association of baseline absolute lymphocyte count (ALC) with change in BK viral load (VL) in a randomised placebo-controlled study of MAU868 in kidney transplant recipients (KTR) (ECCMID 2023) - No abstract available

Clinical • Transplantation

A Randomized Phase 2 Study of MAU868 vs. Placebo to Treat BK Viremia in Kidney Transplant Recipients (KIDNEY WEEK 2022) - "These results support the further development of MAU868 as a therapy for BK viremia. Antiviral Effect and Effect on Kidney Function of MAU868 vs Placebo"

Clinical • P2 data • Infectious Disease • Nephrology • Novel Coronavirus Disease • Transplantation

A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: Vera Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: May 2023 ➔ Feb 2022 | Trial primary completion date: Feb 2023 ➔ Aug 2021

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Transplantation

Vera Therapeutics Reports Positive Interim Phase 2 Data Showing MAU868 Has Significant BK Antiviral Activity in Kidney Transplant Patients (Yahoo Finance) - "Vera Therapeutics...focused on developing and commercializing transformative treatments for patients with serious immunological disease, today announced that interim data from the Phase 2 trial of MAU868 versus placebo to treat BK Virus (BKV) in kidney transplant patients showed that MAU868 was well tolerated and demonstrated significant BK antiviral activity in kidney transplant recipients with BK viremia. These data were delivered today as a late-breaking oral presentation by Daniel C. Brennan..."

A Randomized Phase 2 Study Of Mau868 Vs Placebo To Treat Bk Viremia In Kidney Transplant Recipients (ATC 2022) - "MAU868 was well tolerated, and demonstrated significant BK antiviral activity in kidney transplant recipients with BK viremia. These results support the further development of MAU868 as a therapy for BK viremia."

Clinical • Late-breaking abstract • P2 data • Transplantation

[VIRTUAL] Efficacy of MAU868, a Novel BKV Neutralizing Monoclonal Antibody (mAb), for the Treatment of Severe BK Virus Nephropathy (BKVN) After Kidney Transplant (ATC 2021) - "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."

Clinical • Chronic Kidney Disease • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammatory Arthritis • Pediatrics • Pulmonary Disease • Renal Disease • Respiratory Diseases • Transplantation

[VIRTUAL] A First-in-Human Study of MAU868, a Novel Neutralizing Antibody Against BK Virus (ASH 2020) - "The ex vivo neutralizing activity suggests where the therapeutic range may be for the treatment or prevention of BKV disease. These results warrant further clinical investigation of MAU868 in patients with or at risk for BKV disease."

P1 data • Hematological Disorders • Pain • Transplantation

[VIRTUAL] Pre-Clinical Characterization of MAU868, a Novel Neutralizing Antibody Targeting BK Virus (ASH 2020) - "BKV variants with double or triple alanine substitutions at residues Y169, R170, or K172 were non-viable. Conclusions : The conserved key contact residues within the conformational epitope of VP1 may explain the broad-spectrum antiviral activity of MAU868 and its high in vitro barrier-to-resistance, ideal characteristics for a potential first-in-class therapeutic agent for the treatment or prevention of BKV disease."

[VIRTUAL] A First-in-Human Study of MAU868, a Novel Neutralizing Antibody Against BK Virus (KIDNEY WEEK 2020) - "MAU868 was safe and well tolerated with PK typical for a human IgG. The ex vivo neutralizing activity suggests where the therapeutic range may be for the treatment or prevention of BKV disease. These results warrant further clinical investigation of MAU868 in patients with or at risk for BKV disease."

P1 data • Hematological Disorders • Pain • Transplantation

[VIRTUAL] Preclinical Characterization of MAU868, a Novel Neutralizing Antibody Targeting BK Virus (KIDNEY WEEK 2020) - "The strict conservation of the contact residues within the conformational epitope of VP1 may explain the broad-spectrum antiviral activity of MAU868 and its high in vitro barrier-to-resistance, ideal characteristics for a potential first-in-class therapeutic agent for the treatment or prevention of BKV disease. Funding: Commercial Support"

Preclinical

A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients (clinicaltrials.gov) - P2; N=36; Recruiting; Sponsor: Amplyx Pharmaceuticals; Not yet recruiting ➔ Recruiting; Initiation date: Apr 2020 ➔ Jul 2020

Clinical • Enrollment open • Trial initiation date • Renal Disease • Transplantation

[VIRTUAL] Experience with a BKV-Specific, Neutralizing Monoclonal Antibody (MAU868) for Treatment of Severe BK Virus Nephropathy (BKVN) after Kidney Transplant (FDA EIND #139112) (ATC 2020) - "IS involved induction with thymoglobulin and maintenance with MMF, tacrolimus + prednisone. BK viremia developed 2M post-transplant (PT) and persisted despite IS reduction and switching (MMF to leflunomide) and treatment with IVIg... The medical need for a safe and effective anti-BKV therapy for prevention and/or treatment of clinically significant BK viral infection remains very high. Treatment with MAU868 was associated with viral load reductions and improvements in renal function. The efficacy of MAU868 in the prevention and/or treatment of BKV disease warrants further clinical investigation."

Chronic Kidney Disease • Graft versus Host Disease • Immunology • Lupus • Pediatrics