Adagio(US:IVVD)2025-10-30 12:30COVID Landscape and Vaccine Challenges - COVID vaccines may face durability issues due to the nature of coronavirus immunity[9, 10] - A CDC survey in June-July 2024 indicated that 20% of adults avoided COVID vaccines due to concerns about serious/unknown side effects[13] - Americans have avoided COVID vaccines due to safety fears and mistrust[12] Invivyd's Antibody Approach - Invivyd is developing best-in-class antibody protection and treatment of viral threats[5] - Invivyd's monoclonal antibodies can be engineered for consistent high activity, unlike vaccines[19] - Pemivibart's target epitope has remained relatively unchanged over the past 3 years[22, 23] - VYD2311 is a minimally evolved molecular engineered antibody designed to improve performance[24] REVOLUTION Clinical Program - VYD2311 Phase 1/2 study showed attractive safety at high doses, up to 4500 mg IV[35, 38] - The DECLARATION Phase 3 clinical trial will evaluate prevention of symptomatic COVID at three months[45] - The company aims for a 70%-90% reduction in symptomatic COVID with a 250 mg single dose IM of VYD2311 versus placebo over 3 months[47] Commercial Landscape - Approximately 342 million of the US population is 12+[74] - In the 24-25 flu season, 147 million flu vaccine doses were administered[75] - 36% was the 2023-2024 vaccine dose, ≥7 days 18 and over vaccine efficacy (VE) reduction in hospitalization estimate from CDC[73]