The success of mRNA technology in the development of the COVID-19 vaccine has not only accumulated a wealth of positive efficacy and safety data but has also demonstrated a pathway to advance mRNA technology from R&D to regulatory approval. Innovative product development in this area has also become an area of interest.
Moderna and BioNTech are the stars of the mRNA industry. According to Mizuho Securities, the COVID-19 vaccine is expected to generate more than $40 billion in revenue for each company in 2021 and 2022. In addition to Moderna and BioNTech, more than a dozen companies are working on mRNA vaccines and therapeutics for a range of diseases such as influenza, cystic fibrosis and others.
Revenues from novel coronavirus vaccines are expected to decrease to billions of dollars as the pandemic subsides in the coming years. Oncology, autoimmunity and respiratory will be the next frontiers for mRNA technology.
mRNA pipeline (source: fierce)
Of all of Moderna's R&D pipelines, cytomegalovirus candidates are the most advanced in its preventive vaccine program. And other mid-stage programs include personalized cancer vaccines and local regenerative therapies for cardiac myocardial ischemia.
In the meantime, BioNTech has dozens of programs in development to treat many common diseases: malaria, tuberculosis and even certain allergies. But the area where BioNTech could really succeed is probably oncology, with dozens of vaccines and therapies in development. Only one of them is in phase 2: the melanoma therapy BNT122, in partnership with Roche. In a study with Roche Genentech, the drug is being used in combination with Merck's blockbuster Keytruda to treat metastatic melanoma.
Several large pharmaceutical companies are scrambling to get their hands on mRNA technology, which holds incredible promise for developing therapies and vaccines for everything from oncology to lung disease. Pfizer, for example, believes that mRNA will take a larger share of its pipeline in the years following the success of the BioNTech partnership.
Sanofi has lost the first round of competition to develop a COVID-19 vaccine. Now, Sanofi is attempting a $3.2 billion acquisition of Translate Bio to gain access to the biotech's liver- and lung-focused mRNA research. Translate is conducting a Phase 1/2 trial of a cystic fibrosis therapeutic called MRT5005, which has had varying degrees of clinical success. The biotechnology company has partnered with Sanofi to develop four preclinical vaccine candidates against COVID-19, influenza, viral pathogens and bacterial pathogens.
GlaxoSmithKline is also working with CureVac to develop an mRNA COVID-19 vaccine and has an early rabies prevention program listed in its development pipeline.
Cystic fibrosis is most common among mRNA participants, and Arcturus Therapeutics and ReCode Therapeutics are focused on therapeutic drug development in this area. Strand Therapeutics stands out first in oncology with a solid tumor drug candidate entering human studies in 2022.
mRNA Technology Pipeline Overview, source: reference 1
mRNA Technology Market Forecast, source: reference 1
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1. Xie et al., (2021). Evolution of the market for mRNA technology. Nature Reviews Drug Discovery, https://doi.org/10.1038/d41573-021-00147-y