Fast-Tracked Solutions for COVID-19: New Pathways for Monoclonal Antibodies

Introduction

In an important development for the fight against COVID-19, Invivyd, Inc. has announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a streamlined process for obtaining emergency use authorizations (EUAs) for new monoclonal antibodies (mAbs).

What Are Monoclonal Antibodies (mAbs)?

Monoclonal antibodies are lab-created molecules engineered to serve as substitute antibodies, potentially restoring, enhancing, or mimicking your immune system's attack on a harmful disease like COVID-19. They are designed to target specific parts of the virus to neutralize its activity.

The Agreement with the FDA

Invivyd's proprietary technology platform will now enable rapid evaluation and authorization of new mAb treatments, intended to protect and treat COVID-19. This new process will leverage a master clinical trial protocol, simplifying evaluations and potentially reducing the need for submitting multiple trial protocols for every new mAb.

Compact Clinical Programs

The clinical trials for these treatments will involve hundreds of participants, with the specific number determined in consultation with the FDA. These compact trials, expected to cost between $25-40 million, aim to provide necessary safety and pharmacokinetics data for potential EUA requests.

Comparison to Existing Practices

This new pathway is an extension of the approach previously used for obtaining EUA for PEMGARDA™, Invivyd's monoclonal antibody for pre-exposure prophylaxis (PrEP). The goal is to create a quicker and more economical route to deliver effective COVID-19 treatments.

Importance of Speed in Antibody Development

The rapid evolution of the SARS-CoV-2 virus has been a major obstacle for antibody development. Invivyd's approach aims to match, if not exceed, the pace of viral evolution, ensuring new treatments remain effective against emerging variants.

Focus on Vulnerable Populations

The streamlined pathway targets delivering essential treatments to vulnerable populations who may have compromised immune systems and are at higher risk for severe COVID-19 illness. This includes those who are unlikely to respond adequately to vaccinations.

The Role of Immunobridging

Immunobridging involves comparing the immune response generated by new monoclonal antibodies to those of existing, authorized antibodies. This technique helps to quickly assess the potential effectiveness of new treatments without the need for extensive testing on large populations.

Safety Considerations

While effectively expediting the deployment of new treatments, the safety of these monoclonal antibodies remains a priority. All potential new drugs will undergo rigorous testing to identify any adverse reactions or potential risks before receiving EUA.

Looking Ahead

Invivyd is eager to collaborate with global regulators beyond the U.S. to extend these innovations worldwide. The hope is that this pioneering pathway will set a precedent for future treatments, ensuring rapid delivery of effective medicines to those in need.