Moderna, Inc. recently announced significant advancements in its mRNA medicine portfolio, spanning respiratory diseases, latent viruses, oncology, and rare diseases. This article provides a comprehensive overview of these updates, highlighting key clinical trial results and future development plans, offering valuable insights from both a pharmacist and physician perspective.
Respiratory Disease Franchise: A Focus on Prevention
Moderna’s respiratory franchise targets a substantial market, with ongoing efforts to develop and refine vaccines for COVID-19, RSV, and influenza. These vaccines aim to provide improved efficacy and protection against these prevalent respiratory illnesses.
COVID-19 Vaccine Advancements
Moderna’s updated monovalent XBB.1.5 vaccine (mRNA-1273.815) has shown promising results, demonstrating strong neutralizing activity against several circulating variants, including XBB subvariants, BA.2.86, EG.5, and FL.1.5.1. This updated formulation has received FDA approval for individuals aged 6 months and older.
Seasonal Influenza Vaccine Progress
The mRNA-1010 influenza vaccine continues to demonstrate a favorable safety and tolerability profile in ongoing clinical trials. Interim analysis from the Phase 3 P303 study indicates improved immunogenicity compared to traditional flu vaccines, especially in older adults. This highlights the potential of mRNA technology to enhance vaccine effectiveness.
RSV Vaccine: Regulatory Submissions and Positive Data
Moderna has submitted mRNA-1345, its RSV vaccine for older adults, for regulatory approval globally. The submission is supported by positive data from the ConquerRSV study, which showed high efficacy and a good safety profile. This vaccine represents a significant step forward in preventing RSV-associated lower respiratory tract disease.
Combination Respiratory Vaccines: Streamlining Protection
Moderna is exploring combination vaccines for flu, COVID-19, and RSV to offer broader protection with fewer injections. Several combination trials are currently underway, paving the way for potential availability as early as 2024. This streamlined approach could significantly improve vaccination rates and overall respiratory health.
Latent and Other Viruses: Expanding the Scope
Moderna’s research extends beyond respiratory viruses to address latent infections like CMV, Epstein-Barr virus, and herpes simplex virus. The CMV vaccine (mRNA-1647) is currently in a Phase 3 trial, evaluating its potential to prevent infection in women of childbearing age. Furthermore, multi-valent norovirus vaccines are under development to combat acute gastroenteritis in children and older adults.
Oncology Franchise: Personalized and Targeted Approaches
Moderna’s oncology program focuses on personalized neoantigen therapy, checkpoint vaccines, and triplet vaccines. The personalized neoantigen therapy, mRNA-4157, combined with pembrolizumab, has shown promising results in melanoma trials, significantly improving recurrence-free survival. Further studies are underway to explore its efficacy in other cancer types.
Rare Disease Franchise: Addressing Unmet Needs
Moderna is committed to developing mRNA therapies for rare diseases like methylmalonic acidemia (MMA), propionic acidemia (PA), and phenylketonuria (PKU). Early clinical data for MMA and PA therapies suggest potential improvements in metabolic stability and reduced hospitalizations. These advancements offer hope for patients with limited treatment options.
Conclusion: The Future of mRNA Medicine
Moderna’s ambitious research and development efforts are transforming the landscape of medicine. The continued development of mRNA vaccines and therapies across a wide range of diseases holds immense potential for improving global health outcomes. For personalized treatment plans and the latest information on these advancements, consult with a healthcare professional.
References
- Moderna Expands the Field of mRNA Medicine with Positive Clinical Results Across Cancer, Rare Disease, and Infectious Disease. News release. Moderna. September 13, 2023.
- Gallagher A. FDA authorizes updated COVID-19 vaccine formulations for current variants. Pharmacy Times. September 11, 2023.
- Gallagher A. Moderna files regulatory submissions for mRNA-1345 vaccine against RSV lower respiratory tract disease. Pharmacy Times. July 6, 2023.
- Hippensteele A. Personalize mRNA cancer vaccine with pembrolizumab significantly prolonged recurrence free survival in resected high-risk melanoma. Pharmacy Times. April 17, 2023.
