Invivyd Shares Virology Data on PEMGARDA™ Neutralization Activity

Invivyd, Inc., a biopharmaceutical firm listed on Nasdaq as IVVD, has released comprehensive virology data that supports the neutralization activity of their monoclonal antibody, Pemivibart, against SARS-CoV-2 variants. The company has provided an in-depth genetic and structural analysis of various spike proteins from past and present SARS-CoV-2 variants, focusing on the efficacy of Pemivibart.

To ensure the antiviral activity of Pemivibart remains effective as the virus evolves, Invivyd collaborates with LabCorp’s Monogram Biosciences lab. This collaboration enables Invivyd to conduct thorough virology assessments to monitor any changes in Pemivibart's potency. The latest data indicates that Pemivibart maintains its neutralization potency against contemporary variants like KP.3.1.1 and LB.1, consistent with earlier predominant variants.

Robert Allen, Ph.D., Chief Scientific Officer of Invivyd, commented on the stability of Pemivibart’s neutralization results across a range of SARS-CoV-2 variants. Despite the intrinsic variability in quantitative neutralization assays, the results for Pemivibart have largely remained within the expected range.

Invivyd also updated the ongoing structural analysis of the Pemivibart binding site, revealing no significant mutational changes since the Omicron variant emerged in late 2021. The Pemivibart binding site is defined by 19 key amino acids on the spike protein. These amino acids have shown minimal mutation, which supports the continued efficacy of Pemivibart against emerging variants.

Kristian Andersen, Ph.D., a professor at Scripps Research and a member of Invivyd's scientific advisory board, emphasized the importance of integrating data from clinical and wastewater surveillance, as well as functional genomics, to stay ahead of SARS-CoV-2 evolution. Andersen lauded Invivyd’s efforts over the past few years in integrating these data sources to monitor viral evolution effectively.

Pemivibart, marketed under the name PEMGARDA, is an investigational monoclonal antibody designed for the prevention of COVID-19. It targets the spike protein receptor binding domain (RBD) of SARS-CoV-2, preventing the virus from attaching to the human ACE2 receptor. PEMGARDA has shown neutralizing activity against major SARS-CoV-2 variants, including JN.1, and has been authorized for emergency use by the FDA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised individuals.

However, PEMGARDA is not approved for the treatment of COVID-19 or post-exposure prophylaxis. There are risks associated with its use, including anaphylaxis. The most common adverse events reported include infusion-related reactions, upper respiratory tract infections, viral infections, fatigue, headache, and nausea.

The emergency use authorization (EUA) for PEMGARDA is based on an immunobridging approach, which assesses its potential efficacy for pre-exposure prophylaxis of COVID-19. This approach compares serum virus neutralizing titers with those of other authorized monoclonal antibodies. However, limitations exist, such as variability in cell-based EC50 value determinations and differences in the populations and variants involved in previous clinical trials.

Invivyd's proprietary INVYMAB™ platform combines viral surveillance and predictive modeling with antibody engineering to rapidly generate new monoclonal antibodies against evolving viral threats. The company continues to develop and monitor the effectiveness of PEMGARDA and other antibody candidates through ongoing research and clinical development efforts.