Slide 1: Clinical Efficacy Endpoints from the Phase 3 CANOPY Study Evaluating Pemivibart for the Prevention of COVID-19
Clinical Efficacy Endpoints from the Phase 3 CANOPY Study Evaluating Pemivibart for the Prevention of COVID-19 Myra Popejoy, Anna Holmes, Chloe Katz, Anne-Marie Phelan, Kazima Tosh, Yong Li, Deepali Gupta, Pamela Hawn, Kristin Narayan, Kathryn Mahoney, Mark Wingertzahn Presenting Author: Anna Holmes
Slide 2: Disclosures
DISCLOSURES • Pemivibart is an investigational product candidate that is not approved for use in any country. The safety and efficacy of pemivibart have not been established. • This work was sponsored by Invivyd, Inc • The following authors, Anna Holmes, Chloe Katz, Anne-Marie Phelan, Kazima Tosh, Y
Slide 3: Pemivibart (VYD222)
PEMIVIBART (VYD222) Phase 2/3 clinical trial of adintrevimab for RBD COVID-19 prevention Spike Phase 2/3 clinical trial ACE2 of adintrevimab for COVID-19 treatment Reproduced with permission from Saxena SK, et al. VirusDis. 2020; 31:399-407 under a Creative Commons Attribution 4.0 International lice
Slide 4: A study to evaluate the efficacy and safety of pemivibart for prevention of COVID-19 (CANOPY)
A study to evaluate the efficacy and safety of pemivibart for prevention of COVID-19 (CANOPY)
Slide 5: CANOPY: Phase 3 Clinical Trial
CANOPY: PHASE 3 CLINICAL TRIAL CANOPY STUDY OVERVIEW Pemivibart 4500 mg IV (n=306) Month 6 COHORT A (visit) Moderate-to-severe immune Open label compromise (N=306) // Day 1 Month 3 Month 12 (dosing) (redosing) (last visit) Pemivibart 4500 mg IV (n=322) Month 6 COHORT B 2:1 (visit) At risk of SARS-Co
Slide 6: Study Objectives
STUDY OBJECTIVES A study to evaluate the efficacy and safety of pemivibart for prevention of COVID-19 (CANOPY) Cohort A primary objectives • Evaluate protection against symptomatic COVID-19 based on sVNA titers against SARS-CoV-2 after receiving pemivibart using an immunobridging approach • Evaluate
Slide 7: Exploratory Efficacy Endpoint
EXPLORATORY EFFICACY ENDPOINT RT-PCR–confirmed symptomatic COVID-19 • Participants who presented with symptoms of COVID-19 were instructed to contact site study team and report to site within 2 days of symptom confirmation for collection of nasopharyngeal and saliva samples for central RT-PCR SARS-C
Slide 8: Baseline Demographics and Characteristics
BASELINE DEMOGRAPHICS AND CHARACTERISTICS Cohort A Cohort B Pemivibart Pemivibart Placebo (N=306) (N=322) (N=162) Age, median (range), years 59 (22–83) 47.5 (18–84) 48 (19–78) Age 18 to <55, n (%) 127 (41.5) 204 (63.4) 102 (63.0) Age ≥55, n (%) 179 (58.5) 118 (36.6) 60 (37.0) Age ≥65, n (%) 95 (31.0
Slide 9: Baseline Characteristics
BASELINE CHARACTERISTICS Risk factors for progression to severe COVID-19 Cohort A Cohort B Pemivibart Pemivibart Placebo (N=306) (N=322) (N=162) Risk factor for COVID-19 disease progression, n (%) 306 (100) 213 (66.1) 100 (61.7) Age ≥55 years 179 (58.5) 118 (36.6) 60 (37.0) Obesity (BMI >30 kg/m2) 1
Slide 10: Medical History
MEDICAL HISTORY Criteria for significant immunocompromise Cohort A Immunocompromising condition,a n (%) Pemivibart (N=306) Taking immunosuppressive/immunomodulatory medications 202 (66.0) Acute leukemia, chronic lymphocytic leukemia, non-Hodgkin lymphoma, or multiple myeloma 40 (13.1) Moderate or se
Slide 11: SARS-CoV-2 predominant variants during assessment period
CANOPY SARS-CoV-2 predominant variants during assessment period First participant dosed Cohort B: 8Sep2023 First participant dosed Cohort A: 15Sep2023 First participant redosed Cohort B: 27Nov2023 First participant redosed Cohort A: 5Dec2023 100 80 JN.1 Percentage (%) 60 40 HV.1 EG.5 20 0 Sep 2023 O
Slide 12: Incidence of RT-PCR–Confirmed Symptomatic COVID-19, Hospitalizations, and Mortality: Cohort B
INCIDENCE OF RT-PCR–CONFIRMED SYMPTOMATIC COVID-19, COVID-19– RELATED HOSPITALIZATIONS, AND ALL-CAUSE MORTALITY Cohort B • Cohort B: randomized, placebo-controlled cohort without moderate-to-severe immunocompromise at risk of acquiring SARS-CoV-2 due to regular indoor, unmasked face-to-face interact
Slide 13: Time to Event Analysis: Cohort B
TIME TO EVENT (RT-PCR–CONFIRMED SYMPTOMATIC COVID-19) ANALYSIS Cohort B 25 20 An 84% relative risk Cumulative incidence (%) reduction of RT-PCR– 15 confirmed symptomatic Placebo COVID-19 in Cohort B 10 (immunocompetent population) with pemivibart treatment 5 Pemivibart vs placebo 0 0 15 30 45 60 75
Slide 14: Incidence of RT-PCR–Confirmed Symptomatic COVID-19, Hospitalizations, and Mortality: Cohort A
INCIDENCE OF RT-PCR–CONFIRMED SYMPTOMATIC COVID-19, COVID-19– RELATED HOSPITALIZATIONS, AND ALL-CAUSE MORTALITY Cohort A • Cohort A: single-arm, open-label cohort in adults with moderate-to-severe immunocompromise Outcome through Day 180, n (%) Pemivibart (N=298) Composite RT-PCR–confirmed COVID-19
Slide 15: Time to Event Analysis: Cohort A
TIME TO EVENT (RT-PCR–CONFIRMED SYMPTOMATIC COVID-19) ANALYSIS Cohort A 25 A low rate of RT-PCR– confirmed symptomatic 20 COVID-19 (3.7%) in pemivibart-treated Cumulative incidence (%) 15 participants in Cohort A (significantly immunocompromised 10 population) following 2 doses of pemivibart 5 Pemiv
Slide 16: RT-PCR–Confirmed COVID-19 Through 180 Days
RT-PCR–CONFIRMED COVID-19 THROUGH 180 DAYS Participant characteristics and case severity Cohort A Cohort B Pemivibart Pemivibart Placebo (N=11a) (N=6) (N=19) Age, median (range), years 55 (24–66) 53 (29–84) 50 (20–78) Female, n (%) 8 (72.7) 5 (83.3) 12 (63.2) Severity of COVID-19 illness, n (%) Mild
Slide 17: Exploratory Analysis of COVID-19 Variants in CANOPY
EXPLORATORY ANALYSIS OF COVID-19 VARIANTS IN CANOPY Confirmed infections through Day 180 Cohort A Cohort B Cohort B • Targeted spike sequencing was (pemivibart) (pemivibart) (placebo) attempted on RT-PCR–positive NP event rate: event rate: event rate: samples from confirmed events (positive 3.0% 1.9
Slide 18: Safety Summary (Through Day 180): Cohort A
SAFETY SUMMARY (THROUGH DAY 180) Cohort A • Adverse events occurred in 66.7% of participants • Most TEAEs were mild or moderate, and the most common TEAEs (≥3.0%) were viral infection (7.8%), URTI (7.5%), ILI (4.2%), IRR (3.6%), and UTI (3.6%) • Study drug–related TEAEs occurred in 11.1% of particip
Slide 19: Anaphylaxis Events
ANAPHYLAXIS EVENTS Cohort A • Defined using Sampson clinical criteria for diagnosing anaphylaxis1 • Two participants had anaphylaxis during the first infusion2 – These 2 events were classified as moderate (grade 2) hypersensitivity or infusion-related adverse reactions. The FDA reclassified these ev
Slide 20: Safety Summary (Through Day 180): Cohort B
SAFETY SUMMARY (THROUGH DAY 180) Cohort B • Adverse events occurred in 42.0% of pemivibart participants and 41.4% of placebo participants • Most TEAEs were mild or moderate, and the most common TEAEs (≥3.0%) in pemivibart participants were URTI (8.2%), viral infection (7.3%), and ILI (5.4%), with si
Slide 21: Conclusions
CONCLUSIONS • This exploratory analysis of clinical endpoints through Day 180 following 2 doses of study drug administered 3 months apart showed: – An 84% relative risk reduction of RT-PCR–confirmed symptomatic COVID-19 in Cohort B (immunocompetent population) with pemivibart treatment vs placebo –
Slide 22: Acknowledgments
ACKNOWLEDGMENTS • The authors thank the investigators, the site personnel, and the trial participants and their families • We thank the independent data monitoring committee for their review of safety data • Writing assistance was provided by C. Andrew DeRyke, PharmD, of C Dot Consulting, and funded
Slide 23: Questions
Questions