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     229  0 Kommentare CureVac Announces Dosing of First Participant in a Phase 2 Study in Seasonal Influenza; Development in Collaboration with GSK

    Phase 2 study to assess updated formulations for improved immune responses of multivalent vaccine candidate against influenza B strainStudy initiated following previously reported interim data from Phase 2 Part of combined Phase 1/2 study in …

    • Phase 2 study to assess updated formulations for improved immune responses of multivalent vaccine candidate against influenza B strain
    • Study initiated following previously reported interim data from Phase 2 Part of combined Phase 1/2 study in seasonal influenza
    • Composition of vaccine candidate changed to match all three WHO-recommended flu strains, following recommendation to exclude B/Yamagata lineage

    TÜBINGEN, GERMANY AND BOSTON, MA / ACCESSWIRE / May 28, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced dosing of the first participant in a Phase 2 study of the multivalent seasonal influenza vaccine candidate developed in collaboration with GSK. The study will assess targeted optimizations for improved immune responses of the vaccine candidate against the relevant influenza B strain.

    This new Phase 2 study in the joint CureVac/GSK seasonal influenza program has been initiated following interim data from the Phase 2 part of the ongoing combined Phase 1/2 study in seasonal influenza reported on April 4, 2024 . The reported data showed that among younger and older adults, serum hemagglutinin inhibition (HAI) geometric mean titers elicited by the vaccine candidate against influenza A strains numerically exceeded those of the applied licensed comparator vaccines consistently across all tested dose levels. For influenza B strains, serum HAI geometric mean titers were lower than those elicited by the licensed comparator vaccines across tested age groups and dose levels.

    For the now initiated Phase 2 study, the design of the multivalent vaccine candidate has been changed to address all three World Health Organization (WHO)-recommended influenza strains, following its recommendation from February 2024 to exclude the influenza B/Yamagata lineage and apply a trivalent vaccine format going forward. The three remaining influenza strains include two influenza A strains and one influenza B strain.

    "The previously reported positive interim data of the Phase 2 part of the combined Phase 1/2 study in seasonal influenza confirmed that our technology platform elicits strong overall antibody titers at well-tolerated dose levels, underscoring the potential of our second-generation mRNA backbone in our collaborative seasonal influenza vaccine program," said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. "Historically, it's been challenging to target influenza B strains with a potent vaccine strategy. We are making progress in adapting and optimizing our clinical approach to address this challenge and improve performance against the remaining B strain."

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    CureVac Announces Dosing of First Participant in a Phase 2 Study in Seasonal Influenza; Development in Collaboration with GSK Phase 2 study to assess updated formulations for improved immune responses of multivalent vaccine candidate against influenza B strainStudy initiated following previously reported interim data from Phase 2 Part of combined Phase 1/2 study in …

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