CANOPY trial design1,2

The CANOPY Phase 3 clinical trial studied the efficacy and safety of a single dose of PEMGARDA® 4500 mg for the pre-exposure prophylaxis of COVID-19 in adults ≥18 years of age in 2 cohorts.1

All participants in Cohort A had underlying moderate-to-severe immune compromise.1

cohort-a-chart
sVNA, serum virus neutralizing antibody.
cohort-a-chart Tap to enlarge Cohort information
Timeline of results1,2
Ratio of the geometric mean titers between PEMGARDA against the relevant variant (JN.1) and the reference titer against the Delta variant (B.1.617.2)
RT-PCR-confirmed symptomatic COVID-19, COVID-19-related hospitalization, or all-cause death through Month 3
RT-PCR-confirmed symptomatic COVID-19, COVID-19-related hospitalization, or all-cause death through Month 6
 
RT-PCR, reverse transcription-polymerase chain reaction.
Inclusion criteria2
  • Adults aged ≥18 years weighing ≥40 kg at time of screening
  • Tests negative for current SARS-CoV-2 infection by local antigen test or RT-PCR at time of screening
  • For Cohort A: Has significant immune compromise from causes including solid tumor or hematologic malignancies, CAR-T-cell therapy or HSCT, primary immunodeficiency, advanced HIV infection, or receiving qualifying immunosuppressive therapies
  • For Cohort B: Is at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings
  • Defers receipt of any COVID-19 vaccination/booster for ≥28 days after dosing on Day 1
  • Note: Unless specified by Cohort, the criteria applied to both Cohorts
HSCT, hematopoietic stem cell transplantation.
Exclusion criteria2
  • For Cohort B: Prior receipt of a COVID-19 vaccine or booster within 120 days before randomization
  • Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants, including in the setting of a clinical trial, within 120 days before randomization
  • Prior known or suspected SARS-CoV-2 infection within 120 days before randomization
  • Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before randomization
  • Is acutely ill or has any symptoms suggestive of infection, in the opinion of the investigator

CANOPY trial objectives

Cohort A
(moderate-to-severe immune compromise)1

COHORT A primary efficacy objective: Evaluate protection against symptomatic COVID-19 based on calculated titers against SARS-CoV-2 following PEMGARDA administration by immunobridging to historical data from the EVADE study, which provided evidence of clinical efficacy of adintrevimab, the parent mAb of PEMGARDA.

COHORT A exploratory objective: Collect data on RT-PCR–confirmed COVID-19, COVID-19–related hospitalizations, or all-cause death in participants who received a full initial dose of study drug.

Cohort B
(without moderate-to-severe immune compromise)1

COHORT B exploratory efficacy objective: Evaluate clinical efficacy of PEMGARDA compared to placebo in the prevention of RT-PCR–confirmed COVID-19 in randomized participants without SARS-CoV-2 infection at baseline and without moderate-to-severe immune compromise.

Primary safety objective of both cohorts2: Evaluate the safety and tolerability of PEMGARDA in all treated participants.

Cohort A patient characteristics

Participants included in Cohort A of the CANOPY trial were classified
as moderately to severely immunocompromised1
Actor portrayal.

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References: 1. PEMGARDA Fact Sheet for healthcare providers. Waltham, MA; Invivyd, Inc. 2. Data on file. Invivyd, Inc. Waltham, MA.