Moderna announces program updates, strategic prioritization of mRNA pipeline

Moderna announced program and financial updates demonstrating progress and strategic prioritization of its mRNA pipeline at its annual R&D Day event. The updates include data readouts in the company’s respiratory vaccine portfolio and a revised financial framework. Positive results from the NEXTCove Phase 3 trial in participants aged 12 years and older showed that Moderna’s next-generation COVID-19 vaccine, mRNA-1283, demonstrated non-inferior relative vaccine efficacy compared to Spikevax, with a positive point estimate of 9.3%. rVE was highest at 13.5% in participants aged 65 years and older. The company expects to file for approval in 2024 and intends to use a Priority Review Voucher. Moderna’s RSV vaccine, mRESVIA, has been approved for adults aged 60 years and older in the U.S. and EU. The company intends to file a supplemental Biologics License Application for U.S. approval in 2024 to extend the indicated age range of mRNA-1345 to high-risk adults 18 to 59 years old, and intends to use a Priority Review Voucher. Moderna is no longer pursuing an accelerated approval pathway for the regulatory submission of its standalone flu vaccine, mRNA-1010, to focus its resources on the submission of a potentially more impactful flu/COVID combination vaccine, mRNA-1083, this year. The company plans to start a confirmatory vaccine efficacy study for mRNA-1010 in 2024, funded by previously announced project financing through Blackstone Life Sciences. The Phase 3 study of the company’s investigational combination vaccine against flu and COVID-19, mRNA-1083, met its primary endpoints and elicited higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced flu vaccine in adults 65 years and older. mRNA-1083 also showed an acceptable safety and reactogenicity profile compared to co-administered flu and COVID-19 vaccines. The company expects to file for approval in 2024 and intends to use a Priority Review Voucher. CMVictory is a pivotal Phase 3 trial evaluating mRNA-1647 against primary CMV infection in women 16 to 40 years of age. The trial is accruing cases, and a Data Safety Monitoring Board will evaluate vaccine efficacy from the interim analysis when the trial has accrued 81 confirmed cases. The company expects a vaccine efficacy readout as early as the end of 2024. A Phase 1 trial designed to evaluate the safety, reactogenicity and immunogenicity of a trivalent norovirus vaccinecandidate, mRNA-1403, in participants 18 to 49 years of age and 60 to 80 years of age in the U.S. is ongoing. The company plans to initiate a pivotal Phase 3 trial imminently. The Phase 3 clinical trial for adjuvant melanoma, mRNA-4157, is substantially enrolled and has closed screening to new patients in many countries. The company and its partner Merck will continue engaging with regulators on the program, and remain focused on executing the Phase 3 trial. In an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with MMA, mRNA-3705 was generally well-tolerated to date with no discontinuations due to safety and no events meeting protocol-defined dose-limiting toxicity criteria. The company is on track to begin generating pivotal study data by the end of 2024. n an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with PA, mRNA-3927 was generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria. The company is on track to begin generating pivotal study data by the end of 2024.