8-K: Invivyd's PEMGARDA Maintains Neutralizing Activity Against Dominant COVID-19 Variant XEC

Invivyd announces that PEMGARDA (pemivibart) continues to demonstrate neutralizing activity against the dominant SARS-CoV-2 variant XEC, according to new in vitro data.

Summary

• Invivyd announced that PEMGARDA (pemivibart) shows continued neutralizing activity against the dominant SARS-CoV-2 variant XEC.
• The Centers for Disease Control (CDC) estimates that XEC and KP.3.1.1 accounted for 69% of U.S. circulating variants as of December 21, 2024.
• Invivyd has submitted data to the FDA and anticipates a timely update to the PEMGARDA Fact Sheet for Healthcare Providers.
• PEMGARDA has demonstrated positive neutralization activity against over 75% of currently circulating U.S. variants and all prior variants tested to date.
• The company believes that every clinical variant reported in the CDC COVID Tracker since the Omicron BA.1 lineage has been susceptible to pemivibart.
• Invivyd does not anticipate any meaningful change to pemivibart neutralization activity if the epitope pemivibart targets remains structurally intact.
• VYD2311, a pipeline candidate, also shows neutralizing activity against the XEC variant.
• PEMGARDA is authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain immunocompromised individuals.
• The emergency use of PEMGARDA is only authorized while the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is in effect.
• PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%.

Sentiment

Score: 7

Explanation: The sentiment is moderately positive. The announcement highlights the continued efficacy of PEMGARDA against a dominant variant, which is reassuring. However, the reliance on emergency use authorization and the potential for future variants to reduce susceptibility temper the overall optimism.

Positives

• PEMGARDA continues to demonstrate neutralizing activity against the dominant XEC variant.
• PEMGARDA has shown activity against over 75% of circulating U.S. variants.
• The company anticipates a timely update to the PEMGARDA Fact Sheet for Healthcare Providers.
• VYD2311, a pipeline candidate, also shows neutralizing activity against the XEC variant.
• Invivyd's INVYMAB platform is designed to rapidly generate new mAbs to address evolving viral threats.

Negatives

• PEMGARDA is only authorized for emergency use and is not a substitute for vaccination.
• PEMGARDA's emergency use authorization is contingent on the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic.
• PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%.

Risks

• The emergence of SARS-CoV-2 viral variants may have substantially reduced susceptibility to PEMGARDA.
• The EUA for PEMGARDA could be revised or revoked by the FDA.
• The company's ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize PEMGARDA is uncertain.
• The company's ability to continue as a going concern is a risk.
• The company may not have adequate funding to meet future operating expenses and capital expenditure requirements.

Future Outlook

Invivyd anticipates a timely update to the PEMGARDA Fact Sheet for Healthcare Providers and expects pemivibart to maintain its neutralization activity if the epitope it targets remains structurally intact. The company is also focused on developing VYD2311 as a potential new therapeutic option.

Management Comments

• Robert Allen, Ph.D., Chief Scientific Officer, stated that pemivibart has demonstrated antiviral activity in neutralization assays representing thirty-nine distinct SARS-CoV-2 variants across almost three years of rapid virus evolution.
• Marc Elia, Chairman of Invivyd Board of Directors, noted that the company has constructed what they believe is the world's most advanced and capable antibody discovery and virology platform.
• Amesh Adalja, MD, FIDSA, FACP, FACEP, Senior Scholar, Johns Hopkins Center for Health Security, stated that it is reassuring that PEMGARDA continues to show neutralizing activity against XEC.

Industry Context

This announcement is relevant in the context of ongoing efforts to combat COVID-19 and the continuous evolution of SARS-CoV-2 variants. The continued efficacy of PEMGARDA against emerging variants is crucial for protecting vulnerable populations. Competitors are also working on similar antibody therapies, but Invivyd highlights the durability of PEMGARDA's activity compared to predecessor medicines like Evusheld.

Comparison to Industry Standards

• The press release mentions Evusheld (tixagavimab/cilgavimab) as a predecessor medicine, highlighting PEMGARDA's ongoing activity compared to it.
• The company claims to have the world's most advanced antibody discovery and virology platform, suggesting a leading position in the field.
• The immunobridging approach used to support the EUA for PEMGARDA is based on serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2, including adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA.

Stakeholder Impact

• The continued efficacy of PEMGARDA is positive for immunocompromised individuals who rely on it for pre-exposure prophylaxis.
• Healthcare providers will benefit from updated information in the PEMGARDA Fact Sheet.
• Investors may view the news positively, as it reinforces the value of Invivyd's INVYMAB platform and its ability to address evolving viral threats.

Next Steps

• Invivyd will continue its ongoing industrial virology effort to monitor viral evolution.
• Invivyd anticipates a timely update to the PEMGARDA Fact Sheet for Healthcare Providers.
• The company will continue to develop VYD2311 as a potential new therapeutic option.

Key Dates