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Invivyd Announces General Alignment with FDA on Pathway to Potential EUA for VYD222 and Anticipated Follow-On Monoclonal Antibody Candidates Designed to Prevent COVID-19
Unique, rapid development pathway for monoclonal antibodies (mAbs) using immunobridging via serum neutralizing titers could be enabled by previously generated
About this update from Invivyd, Inc.
[{"type":"text","content":"Unique, rapid development pathway for monoclonal antibodies (mAbs) using immunobridging via serum neutralizing titers could be enabled by previously generated clinical trial data from prototype antibodyVYD222 and potential future Invivyd mAbs are planned to leverage this EUA pathway using consistent manufacturing platform and limited structural changes from proprietary prototype antibody ADG20 (adintrevimab)Company confirms plans to pursue rapid initiation of a VYD222 pivotal clinical trial using serum neutralizing titers as a correlate of protection (surrogate endpoint) to rapidly generate data for a potential VYD222 EUA submission WALTHAM, Mass., June 26, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that it has reached general alignment with the U.S. Food and Drug Administration (FDA) on a pathway to potential emergency use authorization (EUA) for VYD222 and anticipated follow-on monoclonal antibody (mAb) candidates designed to prevent symptomatic COVID-19. The company plans to leverage the pathway, which includes the use of serum neutralizing titers as a correlate of protection (surrogate of clinical efficacy) in an immunobridging approach to a pivotal clinical trial of VYD222, to rapidly generate data to support a potential VYD222 EUA for the prevention of symptomatic COVID-19. Based on FDA feedback, the use of a correlate of protection in an immunobridging approach to a pivotal EUA-directed clinical trial may be a reasonable approach for a new mAb candidate when clinical trial data from a “prototype” mAb is available, provided that the new mAb candidate: (1) is similar to the prototype mAb such that it leverages a consistent manufacturing platform and has limited structural and functional differences, and (2) has supportive nonclinical data, such as favorable in vitro neutralization data against currently circulating SARS-CoV-2 variants. Invivyd plans to leverage this immunobridging pathway to accelerate the clinical development of VYD222 and anticipated follow-on mAb candidates, with ADG20 (adintrevimab) or future proprietary mAbs serving as the prototype. The use of adintrevimab as the potential prototype mAb is proprietary to Invivyd and enabled by the robust safety data and ...