mRNA Vaccine Pipeline Heats Up: Late-Stage Candidates Target Flu, COVID, CMV, and Cancer
Key Insights
Pfizer and BioNTech are advancing an mRNA influenza (search) vaccine, PF-07252220, demonstrating superiority over existing flu vaccines in Phase III trials.
Moderna's mRNA-1083, a combination COVID-19 (search)/influenza (search) vaccine, showed strong immune responses in Phase III, potentially extending the sales of COVID-19 vaccines.
GSK acquired rights to CureVac's mRNA vaccines against COVID-19 (search) (GSK4388067) and influenza (search) (GSK4382276), both currently in Phase II trials.
The pharmaceutical industry is witnessing a surge in mRNA vaccine development, spurred by the success of COVID-19 (search) vaccines. Companies are now expanding their pipelines to target a range of infectious diseases and even cancer, with several late-stage candidates showing promise. This expansion aims to capitalize on the rapid development capabilities of mRNA technology and address unmet medical needs across various therapeutic areas.
Pfizer/BioNTech's Influenza and Combination Vaccine Efforts
Pfizer and BioNTech, the developers of the Comirnaty COVID-19 (search) vaccine, are leveraging their mRNA expertise to develop new vaccines. Their influenza (search) vaccine candidate, PF-07252220, has demonstrated superiority over existing flu vaccines in Phase III trials among adults aged 18 to 64. The companies are also working on a combination mRNA vaccine targeting both influenza and COVID-19. However, recent data showed that the combination vaccine met only one of its two primary immunogenicity endpoints, exhibiting weaker efficacy against the influenza B strain. Adjustments to the candidate are under consideration, potentially delaying its approval.
Moderna's Combination Vaccine and RSV Expansion
Moderna's mRNA-1083, a combination COVID-19 (search)/influenza (search) vaccine, has shown positive Phase III results, generating strong immune responses against both viruses. This positions Moderna as a potential frontrunner in the race to market a combination vaccine. The company aims to offer annual vaccination against both diseases, potentially with improved efficacy compared to existing vaccines, especially in adults over 50. Moderna also plans to incorporate its recently approved RSV vaccine into the combination, creating a triple shot.
GSK/CureVac Collaboration
GSK is also pursuing mRNA vaccines against influenza (search) and COVID-19 (search) through a collaboration with CureVac. GSK acquired the global rights to CureVac's investigational mRNA vaccines, GSK4388067 (COVID-19) and GSK4382276 (influenza), both currently in Phase II trials. This collaboration also includes the option to develop a combination vaccine and a vaccine against avian flu. GSK aims to leverage its capabilities to accelerate the development of these vaccines.
Moderna's Cancer Vaccine: mRNA-4157
Beyond infectious diseases, Moderna is exploring the potential of mRNA vaccines in oncology. Their therapeutic vaccine candidate, mRNA-4157, is being evaluated in Phase III trials in combination with Merck's Keytruda (pembrolizumab) for the treatment of head and neck cancer (search) and melanoma (search). The goal is to enhance the efficacy of Keytruda by stimulating a greater anti-tumor immune response. The success of mRNA vaccines in oncology could validate the technology's broader therapeutic potential and open doors for applications in other areas, such as rare diseases.
Moderna's CMV Vaccine: mRNA-1647
Moderna is also developing mRNA-1647 for cytomegalovirus (search) (CMV (search)), a leading infectious cause of birth defects. The vaccine is currently in Phase III trials, evaluating its efficacy in preventing primary CMV infection in women aged 16 to 40. An interim analysis of the vaccine's efficacy is expected by the end of 2024. Phase II results showed antigen-specific immune responses at all dose levels, with the vaccine being generally safe and well-tolerated. There are currently no approved vaccines to prevent congenital CMV, highlighting the significant unmet need this vaccine aims to address.