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Invivyd Reveals Advancements in Obtaining Potential EUA for VYD222 and Next-Gen Monoclonal Antibodies to Combat COVID-19

Monday, June 26, 2023

Invivyd, Inc., a clinical-stage biopharmaceutical company, announced its progress towards potential Emergency Use Authorization (EUA) for VYD222 and follow-on monoclonal antibody (mAb) candidates designed to prevent symptomatic COVID-19. The company has reached a general alignment with the U.S. Food and Drug Administration (FDA) on the pathway to EUA, leveraging serum neutralizing titers as a measure of protection in an immunobridging approach.

Invivyd plans to use this pathway to accelerate the clinical development of VYD222 and future mAb candidates, with ADG20 (adintrevimab) or proprietary mAbs as the prototype. The use of adintrevimab as the prototype is based on its safety data and clinical results from a Phase 2/3 trial for preventing symptomatic COVID-19. VYD222 is a broadly neutralizing, half-life extended mAb candidate designed to prevent symptomatic COVID-19 in vulnerable populations, such as immunocompromised individuals. It has demonstrated in vitro neutralizing activity against previous SARS-CoV-2 variants and current variants of concern, including Omicron sublineages.

Invivyd has reported positive safety and serum neutralizing titer data from an ongoing Phase 1 trial of VYD222. The company appreciates the FDA's commitment to exploring alternative strategies for expediting mAb development and believes it is well-positioned to generate data for potential EUA submissions of next-generation mAb candidates. Invivyd's aim is to establish a platform and a continuous stream of optimized anti-SARS-CoV-2 mAb candidates to effectively combat viral evolution and protect vulnerable populations.

The company is actively preparing for a pivotal clinical trial of VYD222 and engaging with global regulatory authorities to advance its clinical development program.

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