Invivyd Agrees with FDA on Fast EUA Path for COVID-19 mAbs

Invivyd, Inc., a biopharmaceutical company, has recently aligned with the U.S. Food and Drug Administration (FDA) on a streamlined pathway for the emergency use authorization (EUA) of novel monoclonal antibodies (mAbs) to combat symptomatic COVID-19. This newly established protocol aims to expedite the evaluation and approval process for new mAbs, allowing for quicker deployment in vulnerable populations.

Streamlined Clinical Trial Protocol

The cornerstone of this initiative is the creation of a master, registrational clinical trial protocol. This protocol aims to simplify the evaluation process of new mAbs, eliminating the need for submitting new protocols for each candidate. Under this framework, compact clinical studies involving hundreds of participants (approximately 300-600) will be conducted. The exact number of participants will be determined in consultation with the FDA. The estimated cost for generating the necessary safety and pharmacokinetics (PK) data through this pathway is between $25-40 million.

Rapid Development and Approval

Invivyd plans to utilize this pathway to quickly advance to a registrational clinical trial for VYD2311, exploring intravenous (IV) and potentially other routes of administration. This approach builds on the company's previous success with PEMGARDA™, which used a similar pathway to gain EUA for pre-exposure prophylaxis (PrEP) of COVID-19.

According to Marc Elia, Chairman of Invivyd's Board of Directors, the speed at which SARS-CoV-2 evolves necessitates rapid development pathways to keep up with viral mutations. The company aims to apply this pathway to bring high-value medicines to patients in need, matching the pace of viral evolution.

Advancing mAb Technology

Mark Wingertzahn, SVP of Clinical Development and Medical Affairs at Invivyd, emphasized the importance of rapid discovery and a clear, reliable pathway for establishing clinical evidence. The company is keen to innovate within this defined pathway, exploring various presentations such as intramuscular injections, which could offer better accessibility for both PrEP and treatment of COVID-19.

About PEMGARDA

PEMGARDA™ (pemivibart) is an investigational mAb designed for pre-exposure prophylaxis of COVID-19 in individuals with moderate-to-severe immune compromise. Engineered from adintrevimab, another investigational mAb by Invivyd, PEMGARDA has shown in vitro neutralizing activity against major SARS-CoV-2 variants. It targets the virus’s spike protein receptor binding domain (RBD), inhibiting attachment to human cells. The EUA for PEMGARDA covers its use in adults and adolescents who cannot mount an adequate immune response to COVID-19 vaccination. However, it is not authorized for treatment or post-exposure prophylaxis.

Previous Success and Future Plans

The immunobridging approach used for PEMGARDA involved assessing serum virus neutralizing titers, based on previously authorized mAbs against SARS-CoV-2. Despite some limitations in data variability and population differences, this approach has provided a basis for PEMGARDA’s EUA.

Invivyd aims to continue leveraging its proprietary INVYMAB™ platform, which integrates viral surveillance and predictive modeling with advanced antibody engineering. This platform is designed to facilitate the rapid generation of new mAbs to address evolving viral threats. The company's first mAb received EUA in March 2024, marking the beginning of a series of innovative antibody candidates.

Conclusion

Invivyd’s collaboration with the FDA on a streamlined immunobridging pathway represents a significant advancement in the fight against COVID-19. By expediting the evaluation and approval of novel mAbs, this approach has the potential to deliver effective treatments and preventive measures more quickly, addressing the critical unmet needs of patients vulnerable to COVID-19.

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