Vaccine for the ‘previously undruggable’ just a decade away 

In an exclusive interview with The Guardian, Moderna said that cancer and heart disease vaccines would be ready by 20301. The pharmaceutical firm also provided promising updates on mRNA-4157/V940, which targets different tumour types, at Moderna’s Vaccines Day on 24 March 20232 

The first detailed results of the trial will be presented at the American Association for Cancer Research (AACR) in April 2023. 

Official comments  

Moderna told the Guardian that studies into vaccinations are showing ‘tremendous promise’, with researchers claiming that 15 years’ worth of progress has been made in 12 to 18 months owing to the success of the Covid-19 mRNA jab1. 

Dr Paul Burton, the Chief Medical Officer of Moderna, told the Guardian: “We will have that vaccine and it will be highly effective, and it will save many hundreds of thousands, if not millions of lives. I think we will be able to offer personalised cancer vaccines against multiple different tumour types to people around the world.” 

Burton continued: “I think we will have mRNA-based therapies for rare diseases that were previously undruggable, and I think that 10 years from now, we will be approaching a world where you truly can identify the genetic cause of a disease and, with relative simplicity, go and edit that out and repair it using mRNA-based technology.” 

Personalised vaccines 

mRNA-4157/V940 is a novel investigational mRNA-based personalised cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neo-antigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient’s tumour. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity.  

Personalised cancer vaccines are designed to prime the immune system so that a patient can generate a tailored anti-tumour response specific to their tumour mutation signature. mRNA-4157/V940 is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient’s tumour. KEYTRUDA is an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. Based on early clinical studies, combining mRNA-4157/V940 with KEYTRUDA may potentially provide an additive benefit and enhance T cell-mediated destruction of tumour cells. 

Regulatory updates  

In April 2023, mRNA-4157/V940 was granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA) for the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection. The EMA granted PRIME scheme designation based on positive data from the Phase IIb KEYNOTE-942/mRNA-4157-P201 trial.  

Previously, in February 2023, mRNA-4157/V940 was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the adjuvant treatment of patients with high-risk melanoma following complete resection. The FDA granted Breakthrough Therapy Designation based on positive data from the Phase IIb KEYNOTE-942/mRNA-4157-P201 trial. 



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