Invivyd is a biopharmaceutical company focused on developing innovative therapies for viral infectious diseases, particularly in the area of pre-exposure prophylaxis.
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Invivyd, Inc has shared results from the CANOPY Phase 3 clinical trial of pemivibart (Pemgarda), an investigational monoclonal antibody (mAb) for pre-exposure prophylaxis (PrEP) of COVID-19, at the ACIP meeting. During the off-drug follow-up period (months 7-12), the pemivibart group showed a 64% reduction in the risk of symptomatic COVID-19 compared to placebo, contributing to an overall 12-month relative risk reduction (RRR) of 76% (nominal p < .0001).
Additional results from the 12-month monitoring indicated that the pemivibart arm achieved an 84% RRR in the first six months of treatment after receiving two doses on Days 1 and 90, with an overall protection rate over the 12-month period being statistically significant.
Key Takeaways
- The pemivibart group showed a 64% reduction in symptomatic COVID-19 risk during the off-drug follow-up period, leading to a total 12-month relative risk reduction of 76%.
- No new treatment-emergent adverse events were reported during the follow-up, indicating consistent safety profiles.
- The trial included immunocompromised individuals and immunocompetent adults, highlighting the need for effective preventive measures across different populations.
The follow-up coincided with the summer surge of KP3 and KP311 variants, underscoring ongoing challenges with viral transmission in the US. Despite reduced concentrations of pemivibart during this period, it continued to provide substantial protection against symptomatic disease. No new treatment-emergent adverse events (TEAEs) were reported, consistent with findings from the first six months of the trial. In the placebo group, participants showed an 18% symptomatic COVID-19 attack rate, highlighting persistent uncontrolled transmission of the virus.
Invivydâs chief scientific officer, Robert Allen, PhD, emphasized the significance of these results, noting that mAbs like pemivibart can confer protection even at low serum concentrations. This supports the potential of engineered mAbs to enhance immunity compared to natural infection or vaccination alone.1
The CANOPY trial included two cohorts: Cohort A, comprising immunocompromised individuals, and Cohort B, which consists of immunocompetent adults at risk of exposure due to unmasked interactions. The study aims to evaluate the safety, tolerability, and efficacy of pemivibart as a preventive measure against COVID-19.
Data presented also indicated that incremental vaccine boosts provide roughly a 50% reduction in the likelihood of adults seeking urgent care or hospitalization for 60 days, with benefits declining rapidly thereafter. For immunocompromised individuals, the risk reduction is lower, around 36%, with waning occurring even more swiftly.
Invivyd plans to explore multiple dosing routes, including intramuscular administration, to optimize protective strategies against COVID-19 and continues to develop mAb candidates that offer longer-lasting protection while aligning with regulatory guidelines.
