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Abstract: TH-PO456

A Phase 1b/2a Single Arm Open-Label Study of VB119, an Anti-CD 19 Monoclonal Antibody (Mab), in Active Primary Membranous Nephropathy (PMN): An Interim Report

Session Information

Category: Glomerular Diseases

  • 1302 Glomerular Diseases: Immunology and Inflammation

Authors

  • Cortazar, Frank B., New York Nephrology, Vasculitis and Glomerular Center, Albany, New York, United States
  • Dwyer, Jamie P., University of Utah Health, Salt Lake City, Utah, United States
  • Thomas, Stephen B., ValenzaBio, Inc, Bethesda, Maryland, United States
  • Keenan, Gregory F., ValenzaBio, Inc, Bethesda, Maryland, United States
Background

PMN is a common cause of the nephrotic syndrome. Approximately 70% of cases of PMN are caused by autoantibodies directed against the phospholipase A2 receptor (PLA2R), with the remaining cases caused by autoantibodies against other target antigens, some of which are yet to be defined. Current immunosuppressive therapies fail to achieve complete remission in the majority of patients and treatment-related toxicity remains a concern. VB119 is a Mab which targets the CD19 epitope expressed on maturing B-cells- from pro-B-cell through short-lived plasma cells- but notably not on long-lived plasma cells. The broader spectrum of VB119 compared with anti-CD20 Mabs may translate into improved efficacy in the management of autoantibody-mediated diseases, including MN.

Methods

Enroll approximately 30 participants with biopsy-proven active PMN as evidenced by > 2 gm/gm UPCR proteinuria on first morning void. Eligible participants will receive VB119 at baseline and 14 days later. Participants with ≥ a 25% improvement in proteinuria at 6 months are eligible to receive a subsequent cycle of VB119. Laboratory monitoring includes B-Cell counts, Anti-PLA2R, proteinuria and pharmacokinetic assessments of VB 119. Safety, tolerability and clinical status will be monitored over 18 months.

Results

As of May 2022, 3 participants have been enrolled and administered VB119. One participant has been followed for 18 weeks, he is a 59-yo with a hx of relapsing PLA2R-associated MN with a clinical relapse. He was treated with 100mg of VB119 at day 1 and an additional dose 14 days later. The infusions were well tolerated. The change in assessed laboratory values from baseline to week 18 are shown in the figure. There were no treament related adverse events.

Conclusion

The initial participant treated with VB119 for PMN experienced a reduction in proteinuria and an immunological remission by 18 weeks. All participants receiving VB119 and having observations ≥6 weeks through September 15, 2022 will be reported.

Proteinuria, PLA2R and Total B-cell change over time

Funding

  • Commercial Support