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Noticias de IVVD
Eventos de IVVD
Invivyd Presents Preclinical Data for VMS063 at IDWeek 2026
Invivyd announced the presentation of preclinical data describing its novel, potential first- and best-in-class investigational monoclonal antibody candidate VMS063 at IDWeek 2026 in Washington, D.C. Data demonstrated highly potent in vitro antiviral activity against contemporary measles fusion protein variants, supporting its potential utility for both treatment and prevention of measles. Invivyd has begun manufacturing scale-up toward clinical development in 2027. "A molecule like VMS063 has the potential to transform the measles landscape by leveraging the extraordinary potential of monoclonal antibodies that can, with one molecule, provide both prevention and treatment to fill these gaps," said Michael Mina, chief medical officer and chief epidemiologist.
Invivyd LIBERTY Phase 3 Study Shows Positive Safety Data for VYD2311
Invivyd announced positive, clinically meaningful, and statistically significant topline data from the LIBERTY Phase 3, an active controlled study evaluating the safety and tolerability of VYD2311, Invivyd's investigational COVID-directed monoclonal antibody candidate, mRNA-based COVID-19 vaccine COMIRNATY, and VYD2311 co-administered with mRNA-based COVID-19 vaccine. The study also evaluated the potential for immunologic interference between VYD2311 and mRNA-based COVID-19 vaccine. LIBERTY data demonstrate the favorable safety and tolerability of VYD2311 across both early and late follow-up time periods compared to COVID-19 mRNA vaccine. VYD2311 observed pharmacokinetics, while pending definitive demonstration in the DECLARATION study, demonstrated results in LIBERTY consistent with Invivyd's expectations. Invivyd has been in constructive ongoing dialogue with the U.S. Food and Drug Administration regarding regulatory pathways for VYD2311, including a recent Type C meeting in September and other discussions with FDA leadership. As a result of those discussions, Invivyd intends to submit a BLA under the Accelerated Approval Program pending results from the ongoing DECLARATION study.
Invivyd Appoints Marc Elia as CEO
Invivyd announced that the company has appointed Marc Elia, current chairman of the Invivyd board of directors, as CEO of the company. He will serve as chairman and CEO of Invivyd going forward.
Invivyd Expects Top-Line Data for VYD2311 by End of Q3
Invivyd continues to expect top-line data from the VYD2311 program around the end of Q3. At that time, Invivyd plans to either unblind the DECLARATION study in its entirety and submit a Biologics License Application towards traditional product approval, or partially unblind the study and submit a BLA towards Accelerated Approval on the basis of antiviral activity and safety, with greater statistical power expected to be achieved in a post-approval confirmatory clinical cohort. Preparing such options for filing pathway will substantially reduce the risk that play of chance related to the statistical powering in DECLARATION intrudes into the near-term availability of VYD2311, a highly active anti-COVID-19 monoclonal antibody that is functionally identical to prior Invivyd antibodies adintrevimab and pemivibart. The company has been in discussions with FDA about potential paths forward and believes that either route can provide a near-term pathway to make VYD2311 available for millions of Americans, subject to FDA review and approval. Invivyd will provide further updates in the coming weeks as previously guided.
Invivyd Receives FDA Termination Notice for Pemgarda EUA
Invivyd announced that the FDA has sent Invivyd a notice of termination for the Pemgarda Emergency Use Authorization, or EUA, following the U.S. Department of Health and Human Services', or HHS, announcement of advanced notice of termination of the COVID-19 EUA declaration on June 30, with an effective date of June 29, 2027. Consequently, the EUA for Pemgarda is set to terminate on June 29, 2027. Pemgarda is Invivyd's investigational monoclonal antibody authorized by the FDA under an EUA since March 2024 for the pre-exposure prophylaxis of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.
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