8-K: Invivyd's PEMGARDA Maintains Neutralizing Activity Against Dominant COVID-19 Variant LP.8.1

Invivyd announces that PEMGARDA (pemivibart) continues to demonstrate clinically meaningful in vitro neutralizing activity against the currently dominant SARS-CoV-2 variant LP.8.1.

Summary

• Invivyd announced that PEMGARDA (pemivibart) shows continued neutralizing activity against the LP.8.1 variant of SARS-CoV-2.
• The LP.8.1 variant, along with XEC and KP.3.1.1, constitutes the majority of current national SARS-CoV-2 variants, all of which are susceptible to PEMGARDA.
• Pemivibart's antiviral activity has remained consistent since the Omicron BA.2 variant.
• VYD2311, Invivyd's next-generation COVID-19 monoclonal antibody candidate, also demonstrates stable epitope and clinically meaningful in vitro neutralization against LP.8.1.
• Data has been provided to the U.S. FDA, and an update to the PEMGARDA Fact Sheet for Healthcare Providers is anticipated.
• PEMGARDA is authorized in the U.S. for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients.
• Invivyd estimates that every clinical variant reported in the CDC COVID Data Tracker since the Omicron BA.2 lineage has been susceptible to pemivibart.
• Vaccine efficacy is reduced for immunocompromised people to nearly 0% after four to six months.
• Immunocompromised people with COVID-19 are two times more likely to be in the ICU, three times more likely to require invasive mechanical ventilation, and four times more likely to die in the hospital than the general population.

Sentiment

Score: 7

Explanation: The sentiment is moderately positive due to the continued neutralizing activity of PEMGARDA against dominant variants and the development of VYD2311. However, the emergency use authorization status and potential risks associated with emerging variants temper the overall sentiment.

Positives

• PEMGARDA demonstrates continued neutralizing activity against dominant SARS-CoV-2 variants.
• VYD2311 also shows stable epitope and clinically meaningful in vitro neutralization against LP.8.1.
• The company's technology platform allows for assessment, monitoring, development, and adaptation to create best-in-class antibodies.
• Invivyd anticipates updating the PEMGARDA Fact Sheet for Healthcare Providers.

Negatives

• PEMGARDA is only authorized for emergency use and not fully approved.
• The emergency use of PEMGARDA is only authorized for the duration of 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

• SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA.
• PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants.
• The EUA granted by the FDA for PEMGARDA could be revised or revoked.
• The company's ability to continue as a going concern is a risk factor.

Future Outlook

Invivyd anticipates updating the PEMGARDA Fact Sheet for Healthcare Providers and aims to improve the properties of its medicines as it scales them to larger populations rapidly. The company is devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2.

Management Comments

• Robert Allen, Ph.D., Chief Scientific Officer of Invivyd, commented that the ongoing in vitro neutralization activity as reported for pemivibart is a demonstration of their foundational hypothesis.
• Timothy Lee, Chief Commercial Officer of Invivyd, commented on the risks of COVID-19 for vulnerable patient populations.

Industry Context

This announcement is relevant in the context of ongoing efforts to combat COVID-19, particularly in vulnerable populations. The continued efficacy of PEMGARDA against emerging variants is crucial, as is the development of new monoclonal antibodies like VYD2311. Competitors in this space include companies developing vaccines and antiviral treatments for COVID-19.

Comparison to Industry Standards

• The document mentions immunobridging 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.
• The document notes limitations of the data supporting the benefits of PEMGARDA, including that evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating.

Stakeholder Impact

• Shareholders: The announcement of continued neutralizing activity may positively impact investor confidence.
• Immunocompromised Patients: The continued efficacy of PEMGARDA provides a valuable option for pre-exposure prophylaxis.
• Healthcare Providers: The updated Fact Sheet will provide important information for the use of PEMGARDA.

Next Steps

• An update to the PEMGARDA Fact Sheet for Healthcare Providers is anticipated.
• Invivyd will continue to assess, monitor, develop, and adapt to create best-in-class antibodies.

Key Dates