Invivyd to Seek EUA for COVID-19 Treatment in Immunocompromised per FDA Feedback

Invivyd, Inc., a biopharmaceutical firm based in Waltham, Massachusetts, has announced plans to seek emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its investigational monoclonal antibody, pemivibart (PEMGARDA™). This EUA application aims to treat mild to moderate symptomatic COVID-19 in immunocompromised individuals, leveraging an immunobridging pathway. This approach is based on serum virus neutralizing antibody (sVNA) titers, informed by the company's prior clinical successes with the prototype antibody adintrevimab in the STAMP trial.

The planned EUA submission is intended to address the treatment needs of U.S. residents with moderate-to-severe immune compromise for whom other COVID-19 treatment options may not be suitable. Following this submission, Invivyd aims to conduct a compact clinical trial to confirm the safety, pharmacokinetics, and clinical virology of pemivibart.

Marc Elia, Chairman of Invivyd's Board of Directors, expressed satisfaction with aligning with the FDA to meet the critical medical needs of immunocompromised patients. He underscored the importance of monoclonal antibodies (mAbs) targeting the SARS-CoV-2 spike protein, which have previously been effective in treating symptomatic COVID-19. The company plans to have approximately 100,000 doses available by the second half of 2024 and is exploring ways to expand and accelerate product availability.

Mark Wingertzahn, Senior Vice President of Clinical Development and Medical Affairs, emphasized the urgency of this initiative. He noted that immunocompromised individuals are disproportionately affected by COVID-19-related hospitalizations and deaths, indicating a significant need for effective treatment options like pemivibart. Observational studies have shown that this population remains at high risk, and an infused antibody therapy could be a highly beneficial treatment approach.

Brian Koffman, Co-Founder and Chief Medical Officer of the Chronic Lymphocytic Leukemia Society, highlighted the inadequacy of current treatment options for those who are immunocompromised. He stressed the potential value of a new monoclonal antibody treatment, given its effectiveness against previous variants of the virus.

Invivyd maintains its 2024 financial guidance, projecting $150-$200 million in net product revenue for PEMGARDA and at least $75 million in cash and cash equivalents by year-end. This guidance does not account for potential COVID-19 treatment sales or inventory build-up.

PEMGARDA (pemivibart) is a half-life extended investigational monoclonal antibody derived from adintrevimab. It has shown in vitro neutralizing activity against major SARS-CoV-2 variants and targets the virus's spike protein receptor binding domain (RBD), thereby inhibiting its attachment to human ACE2 receptors. Although not yet approved, PEMGARDA has been authorized for emergency use for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised individuals.

To support the EUA for PEMGARDA, Invivyd used an immunobridging approach based on serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs previously authorized for EUA.

Invivyd is committed to providing protection against serious viral infectious diseases, starting with SARS-CoV-2. The company leverages its proprietary INVYMAB™ platform, which combines viral surveillance, predictive modeling, and advanced antibody engineering to rapidly generate new monoclonal antibodies that keep pace with evolving viral threats.