Vera Therapeutics, Inc. · NASDAQ:VERA
Vera Therapeutics — ATC 2023 (American Transplant Congress), San Diego
12 slides from Vera Therapeutics's conference presentation, June 2023
Slide 1: A Randomized Phase 2 Study of MAU868 vs Placebo for BK Viremia in Kidney Transplant Recipients
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 Stanley C. Jordan1, Daniel C. Brennan2, Amy K. Patick3, Leanne B. Gasink3, Celia J. Lin4, Ajit P. Limaye5 1Cedars-Sinai Medical Center, Los Angeles, CA
Slide 2: Financial disclosures
Stanley C. Jordan, MD Director, Nephrology & Transplant Immunology Cedars-Sinai Medical Center, Los Angeles, California, USA I have financial relationship(s) with: Consultation fees & grants, Vera Therapeutics Consultation fees & grants, CareDx Consultation fees & grants, Regeneron Consultation fees
Slide 3: Kidney Transplants: BKV Nephropathy is a Leading Cause of Allograft Loss
Kidney Transplants: BKV Nephropathy is a Leading Cause of Allograft Loss The median allograft survival was ~6 years • Poor transplant outcomes with BKV shorter in patients who developed BK viremia reactivation – BK viremia is associated with reduction in renal function and allograft survival Accumul
Slide 4: MAU868: First Known Neutralizing Antibody Targeting BK Virus
MAU868: First Known Neutralizing Antibody Targeting BK Virus • Novel target: mAb that neutralizes viral MAU868 Blocks BK Virion Binding infection by blocking BK virion binding to Designed to disrupt cell surface binding and to prevent cell entry and spread of infection host cells • Activity shown ag
Slide 5: Phase 2 Trial of MAU868 in Kidney Transplant Patients with BK Viremia
Phase 2 Trial of MAU868 in Kidney Transplant Patients with BK Viremia MAU868-201: Randomized, Double-blind, Placebo-controlled Phase 2 Study Kidney Transplant MAU868 Patient follow-up Patients with BK Viremia 2:1 Randomization Placebo Patient follow-up Week 0 4 8 12 16 36 MAU868 dose: Cohort 1: 1350
Slide 6: Baseline Characteristics
Baseline Characteristics MAU868 Cohort 1, n=10 Cohort 2, n=10 All, n=20 Placebo, n=8 Age, mean 61 56 58 53 Male, n (%) 9 (90) 9 (90) 18 (90) 5 (63) Asian 2 (20) 0 2 (10) 0 African-American 4 (40) 1 (10) 5 (25) 4 (50) Race/ethnicity, n (%) White 4 (40) 7 (70) 11 (55) 3 (38) Other 0 2 (20) 2 (10) 1 (1
Slide 7: Rapid and Sustained Decrease in Viral Load with MAU868
Rapid and Sustained Decrease in Viral Load with MAU868 Loading Dose Did Not Appear to Increase Response to Therapy as Measured by Viral Load in Plasma and Urine MAU868 Cohort 1 MAU868 Cohort 2 Placebo Plasma BK VL Urine BK VL 0.0 0.0 Mean VL reduction, log10 DNA c/mL -0.5 -0.5 -1.0 -1.0 -1.5 -1.5 -2
Slide 8: Both MAU868 Dosing Cohorts Demonstrated a Similar Plasma Virologic Response Greater than Placebo
Both MAU868 Dosing Cohorts Demonstrated a Similar Plasma Virologic Response Greater than Placebo MAU868 Cohort 1, n=10 MAU868 Cohort 2, n=10 All MAU868, n=20 Placebo, n=8 VL Decrease ≥1 log10 c/mL VL <Level of Detection VL <103 c/mL VL <104 c/mL from Baseline 100 80 80 80 80 75 75 70 70 65 63 60 60
Slide 9: Both MAU868 Dosing Cohorts Were Well Tolerated
Both MAU868 Dosing Cohorts Were Well Tolerated MAU868 Patients, n (%) Cohort 1, n=10 Cohort 2, n=10 All, n=20 Placebo, n=8 Any AEs/TEAEs 10 (100) 9 (90) 19 (95) 8 (100) • No AEs or TEAES led to Mild 1 (10) 1 (10) 2 (10) 2 (25) discontinuation of study drug Moderate 4 (40) 4 (40) 8 (40) 3 (38) • No S
Slide 10: SAEs were Consistent with Renal Transplant Patients
SAEs were Consistent with Renal Transplant Patients MAU868 Cohort 1 MAU868 Cohort 2 Placebo n=10 n=10 n=8 Patients with 6 (60) 6 (60) 2 (25) SAEs, n (%) • Diarrhea, hypotension, urinary • Hernia, COVID-19 pneumonia, • Severe transaminitis tract infection acute respiratory syndrome • Worsening • Seps
Slide 11: Conclusions
Conclusions • MAU868 is a potential first-in-class human IgG1 monoclonal high-affinity neutralizing antibody against BK virus • Post-renal transplant patients with BK viremia who received MAU868 had a greater virologic response than those receiving placebo • A loading dose did not appear to increase
Slide 12: Acknowledgments
Acknowledgments We thank all the patients who participated in this study and their families. We also thank the investigators and clinical research staff at the following clinical sites: Kassem Safa, MD, Massachusetts General Hospital Cynthia Fisher, MD, University of Washington Medical Rowena Delos
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