Elizabeth Webster

Elizabeth Webster asked about the refiling strategy for the flu and COVID combination vaccine given the mRNA-1010 RTF, any regulatory read-through in the U.S., the study data initially submitted, and the highest probability of success among the five INT histologies based on generated data.

Answer

Stephen Hoge, President, explained that the flu/COVID combination vaccine is progressing internationally, with European approval hoped for this year. U.S. refiling for the combo vaccine is gated by feedback from the Type A meeting regarding the mRNA-1010 flu vaccine. He detailed the initial submission data for mRNA-1010, including a 41,000-person Phase III study showing 27% superior relative vaccine efficacy and a separate Phase III immunogenicity study against Fluzone High Dose. For intismeran, he stated the highest probability of success is in the Phase III adjuvant melanoma study, given the strong five-year Phase IIb data.

Elizabeth Webster asked about the flu and COVID combination vaccine refiling given the mRNA-1010 RTF, potential regulatory read-through in the U.S., the study data included in the initial submission, and what might be needed for refiling. She also inquired about which of the five INT histologies has the highest probability of success.

Answer

Stephen Hoge, President, explained that the combo vaccine refiling in the US is gated by feedback from the Type A meeting for mRNA-1010. He detailed the comprehensive Phase III data for mRNA-1010, including superior relative vaccine efficacy and immunogenicity. For INT, he stated the highest probability of success is in Phase III adjuvant melanoma, given the strong 5-year Phase IIb data.

Elizabeth Webster, on for Salveen Richter, inquired about the status of dialogue with regulatory authorities.

Answer

CEO Sean Nolan reported that Taysha has an upcoming Type B meeting with the FDA, a result of its RMAT designation. The key goals are to align on the cadence of interactions, share incoming clinical and natural history data in near real-time, and use this information to inform the trial design and endpoints for Part B of the study. He indicated that updates on this front would be provided in the coming quarter.