COVID-19 prevention

Search documents
Invivyd Announces Continued Neutralizing Activity of PEMGARDA® (pemivibart) and VYD2311 Against Currently Dominant SARS-CoV-2 Variant XFG (“Stratus”)
GlobeNewswire· 2025-08-18 20:32
Core Insights - Invivyd, Inc. announced positive in vitro neutralization data for PEMGARDA (pemivibart) against the XFG variant of SARS-CoV-2, indicating no significant change in neutralization activity [1][2][3] - The company anticipates continued clinical activity for pemivibart as the targeted epitopes remain structurally intact across various SARS-CoV-2 variants [2][3] - Invivyd is advancing its next-generation monoclonal antibody candidate, VYD2311, which has shown similar neutralization results with higher potency [3][12] Company Developments - PEMGARDA is authorized by the FDA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients, demonstrating consistent in vitro neutralizing activity over several years [1][4][7] - The company plans to provide updated data on PEMGARDA's neutralizing activity to the FDA, which will be included in the PEMGARDA Fact Sheet for Healthcare Providers [4][5] - VYD2311 is designed to offer a more patient-friendly administration route and aims to address the urgent need for new COVID-19 prophylactic and therapeutic options [12][13] Industry Context - COVID-19 activity is reportedly on the rise in the U.S., with high levels of viral activity detected in wastewater across 12 states, and infections growing in 34 states [2][3] - The CDC's data indicates that the XFG variant is contributing to a growing wave of COVID-19 cases in America, reinforcing the need for effective treatments like PEMGARDA and VYD2311 [5][6] - The stability of the epitopes targeted by Invivyd's monoclonal antibodies across SARS-CoV-2 evolution highlights the company's robust molecular design strategy [3][4]
Invivyd Files Citizen Petition Urging FDA to Focus on Monoclonal Antibodies For Endemic-Virus-Era COVID-19 Prevention, and to Re-Assess COVID-19 Vaccine Efficacy
GlobeNewswire News Room· 2025-05-14 11:01
Core Viewpoint - Invivyd, Inc. has submitted a Citizen Petition to the FDA advocating for a shift in the development approach for COVID-19 vaccines and monoclonal antibodies to restore public trust and enhance the effectiveness of preventive measures against COVID-19 and other viral diseases [1][6]. Group 1: Changes in Immunity and Virus Evolution - The immunological landscape in the U.S. has changed significantly since 2020, with most Americans now having some level of immunologic memory due to vaccinations or infections [2]. - The SARS-CoV-2 virus has evolved from the original Wuhan strain to more immune-evasive Omicron variants, leading to reduced vaccine efficacy against these newer strains [3]. Group 2: Vaccine Efficacy and Clinical Trials - There is a better understanding of the rapid waning of vaccine efficacy, necessitating long-term clinical evaluations rather than short-term studies [4]. - Invivyd's petition calls for new clinical trials to assess COVID-19 vaccines in a modern U.S. population, including seropositive individuals, and against contemporary Omicron variants, with efficacy measured over six months or longer [6]. Group 3: Monoclonal Antibodies and Regulatory Recommendations - Invivyd emphasizes the importance of developing non-vaccine solutions, such as monoclonal antibodies, to provide high-quality alternatives for the American population [6]. - The petition recommends that the FDA consider serum virus neutralizing antibody (sVNA) titers as a basis for Biologics License Application (BLA) approval, which would benefit patients and healthcare providers [7]. Group 4: Company Overview - Invivyd, Inc. is focused on delivering protection against serious viral infectious diseases, starting with SARS-CoV-2, and has received emergency use authorization for a monoclonal antibody from the FDA [8].