Moderna, Inc. announced business and clinical updates across its franchises and introduced various novel development programs at the company’s annual R&D Day.
Stéphane Bancel, CEO of Moderna, stated, “Our mRNA platform is working. With today’s positive Phase 3 flu results, along with previous results in COVID and RSV, we are now three for three on advancing respiratory disease programs to positive Phase 3 data.”
Mr. Bancel also stated, “In the near term, we look forward to product launches in our oncology, latent, rare, and infectious disease franchises. In the fourth quarter of this year, we also expect to provide data on our next-generation COVID and flu combination, mRNA-1083, and additional efficacy analysis on our Phase II INT [individualized neoantigen therapy] study. With significant momentum across the business and our pipeline, we are excited by the near future and focused on execution.”
Through more than a decade of investment in science, Moderna has created the field of mRNA medicine. Moderna has advanced a diverse pipeline and demonstrated the potential for clinical benefit in cancer (mRNA-4157), in three different rare diseases (mRNA-3705, mRNA-3927, mRNA-3745), and multiple infectious disease vaccines (mRNA-1273, mRNA-1345, mRNA-1010). Moreover, Moderna has advanced six programs into late-stage development, including two approved or filed for approval and three more that have completed phase III enrollment. Moreover, Moderna expects to double the number of programs in phase III by 2025 and launch up to 15 products across cancer, rare diseases, and infectious diseases in 5 years. Up to four of those launches could come by 2025.
In accordance with its mission, over the next 5 years Moderna will continue to invest in science to expand the field of mRNA medicine into new frontiers, and the company projects to advance up to 50 new candidate medicines into clinical trials across established and new modalities.
Updates and recent advancements include:
• On September 11, 2023, the FDA approved Moderna’s updated COVID-19 vaccine
• Moderna’s next-generation, refrigerator-stable COVID-19 vaccine, mRNA-1283, demonstrated promising results in multiple clinical studies and has completed its phase III trial enrollment
• The company’s flu vaccine, mRNA-1010, met its primary endpoint in the phase III trial; separate phase I/II data demonstrated higher hemagglutination inhibition titers than Fluzone HD
• The company is also investigating combination respiratory vaccines, including flu/COVID-19 (mRNA-1073: mRNA-1010 + mRNA-1273) phase I/II; flu/ respiratory syncytial virus (RSV; mRNA-1045: mRNA-1010 + mRNA-1345) phase I; flu/COVID-19/RSV (mRNA-1230: mRNA-1010 + mRNA-1273 +mRNA-1345) phase I; and flu/COVID-19 (mRNA-1083: mRNA-1010 + mRNA-1283) phase I/II. Moderna expects to have a combination vaccine available as early as 2025 and plans to regularly update combinations with improved next-generation vaccine candidates as appropriate
• Moderna announced the completion of RSV Biologics License Application filing (mRNA-1345); completion of adult enrollment in the phase III trial of mRNA-1647, a first-in-class vaccine against cytomegalovirus (CMV); and the phase III trial of mRNA-1283, a next-generation COVID-19 vaccine
• With its partner Merck, Moderna plans to begin a second phase III trial of mRNA-4157, its INT, in combination with Keytruda, for non–small cell lung cancer later this year; updated efficacy follow-up from the ongoing phase II study in adjuvant melanoma is expected in the fourth quarter
• Moderna’s rare disease portfolio, which includes therapies targeting methylmalonic acidemia (MMA), propionic acidemia, glycogen storage disease, and phenylketonuria (PKU), may represent a $10 billion market while also addressing significant unmet medical needs. Moderna expects up to four rare disease product launches in the next 5 years
• Positive clinical data announced in mRNA-3705, a treatment for methylmalonic acidemia with interim results from the global phase I/II clinical trial of mRNA-3705, demonstrated encouraging initial pharmacodynamic data, with dose-dependent reductions in methylmalonic acid in Cohorts 2 and 3. Early results suggest potential decreases in annualized metabolic decompensation events, frequency, and MMA-related hospitalizations compared with pretreatment
• Examples of others under investigation include mRNA-3927 for propionic academia and mRNA-3210 for PKU. Moderna has opened an Investigational New Drug Application for mRNA-3210
• Moderna is currently developing vaccines against six latent and other viruses with unmet or underserved needs, including CMV, Epstein Barr virus, herpes simplex virus, varicella-zoster virus, norovirus, and HIV.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.