Monoclonal Antibody Reduces Symptomatic COVID-19 Risk by 84% in Immunocompromised

In results reported today, topline data shows the monoclonal antibody, pemivibart, was highly efficacious in preventing the onset of symptomatic COVID-19 compared to a placebo in the ongoing CANOPY phase 3 clinical trial. Participants who received the monoclonal antibody experienced a 1.9% rate of confirmed symptomatic COVID-19 compared to an 11.9% rate for participants receiving placebo, an 84% relative risk reduction.¹

“We are thrilled with the clinically meaningful protection shown by pemivibart in these exploratory analyses during a 180-day period with various SARS-CoV-2 circulating variants,” Mark A. Wingertzahn, senior vice president of Clinical Development and Medical Affairs, Invivyd, said in a statement. "Importantly, given the timeframe in which this study was conducted [XBB and JN1 virus lineages], these CANOPY data suggest that even with a substantial population-level backdrop of immunologic experience with SARS-CoV-2 from either infection or vaccination, additional protection against symptomatic COVID-19 may be available with monoclonal antibodies, including for certain individuals with moderate-to-severe immunocompromise.”¹

Pemivibart is a half-life extended investigational monoclonal antibody (mAb). It was engineered from adintrevimab, Invivyd’s investigational mAb. It is a monoclonal injection (4500 mg) for intravenous use.

EUA

Earlier this year, the FDA granted an emergency use authorization (EUA) for pemivibart for the pre-exposure prophylaxis (PrEP) of COVID-19 for both adults and adolescents at least 12 years of age, and weighing at least 40 kg (88.1 lbs) who are immunocompromised.² The antibody is indicated for those individuals who are unlikely to mount an adequate immune response to COVID-19 vaccination, and recipients of pemivibart should not be currently infected with or have had a known recent exposure to an individual infected with COVID-19.²

What the Data Showed

Invivyd reported data from 2 cohorts of its ongoing CANOPY study. Participants received 2 doses of pemivibart (cohort A and B) or placebo (cohort B) administered via intravenous infusion 3 months apart; safety, serum virus neutralizing antibody (sVNA) titers and clinical endpoints were assessed at pre-specified timepoints over the 180-day period.

In cohort A, there were 298 participants, and cohort B had 317 participants in the pemivibart arm and 160 in the placebo arm. Table 1 and Table 2 offer further data on the individual cohorts.

Safety Profile

According to the investigators, the most common treatment-emergent adverse events (TEAE) In cohort A, were viral infection (7.8%), upper respiratory tract infection (URTI) (7.5%), influenza like illness (4.2%), infusion related reactions (3.6%), and urinary tract infection (3.6%). Anaphylaxis was observed in 4 participants (0.6%) – 2 participants during the first infusion and 2 participants during the second infusion; 2 reactions were life-threatening, and all led to permanent discontinuation of pemivibart. Systemic infusion-related reactions and hypersensitivity reactions were observed within 24 hours of dosing pemivibart in 8.2% and 3.9% of participants after the initial dose and redose, respectively, of this open-label single-arm cohort and were generally mild to moderate in severity.¹

For cohort B, the most common TEAEs in the pemivibart arm were URTI (8.2%), viral infection (7.3%), and influenza like illness (5.4%), with similar percentages in the placebo arm. ¹

“The positive CANOPY clinical efficacy data through 6 months is encouraging and will be helpful to clinicians in making an informed decision about Pemgarda use in their immunocompromised, at-risk patients," Cameron R. Wolfe, MBBS, MPH, professor of Medicine, Transplant Infectious Disease at Duke University School of Medicine, said in a statement. "The risk of COVID-19 for immunocompromised people remains disproportionate and having a mAb in the toolbox for pre-exposure prophylaxis is extremely beneficial.”¹

References

1.Invivyd Announces PEMGARDA™ (pemivibart) Demonstrated 84% Relative Risk Reduction in Symptomatic COVID-19 Compared to Placebo in an Exploratory Analysis from Ongoing CANOPY Phase 3 Clinical Trial.Invivyd press release. August 27, 2024. Accessed August 27, 2024.
https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-fda-authorization-emergency-use-pemgardatm
2. Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19. Invivyd press release. March 22, 2024. Accessed August 27, 2024.
https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-pemgardatm-pemivibart-demonstrated-84-relative