Moderna: the first mRNA vaccine moves closer to commercialization!
13 January 2020
Moderna Therapeutics (MRNA US), a component of our Biotechnology and Healthcare M&A certificates, is gaining ~15% today after submitting positive interim Phase 1 data on mRNA-1647 vaccine against cytomegalovirus.
We believe Moderna could become the leading mRNA player and will be a potential M&A target.
These results showed that after the third vaccination, the volume of antibodies(proteins used to fight pathogens)continued to increase. It proves that the immune response is durable. The goodsafety profile, with no significant side effects,was also confirmed. These final data support the mRNA-based approach and significantly derisk the pipeline.
The company also announced that it had administered the first patient in a Phase 2dose confirmation study. This marks the start of the first-ever messenger RNA-based vaccine for an infectious disease to be tested in Phase 2.
Phase 2 interim data are expected in 2H 2020, and Phase 3 should start in 2021 with a commercial launch in 2022. Phase 2 will test the vaccine on 252 healthy adults, and Moderna expects to recruit 8’000 patients for Phase 3.
Cytomegalovirus infection in a pregnant woman is a common cause of malformations in the fetus and about 25’000 US newborns infected each year. There is today no vaccine, and there is a critical medical need. A universal vaccine in Cytomegalovirusis multi-billion opportunity for Moderna. The HPV vaccine Gardasil (produced by Merck) registered sales of $1.5bn during the first full year after the launch.
As we explained in September last year,during our last breakfast presentation on gene therapy, mRNA therapeutics have the potential to be the next frontier in vaccines to prevent several disorders from cancer to infectious diseases.
Moderna has a strong pipeline with 21 mRNA-based candidates, 13 of which are in clinical trials in a wide range of therapeutic areas (infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases).Each achievement, including positive data and successful completion of a clinical phase, brings an additional step in the de-risking of Moderna’s mRNA platform. The closer the company is to commercialization, the more potential buyers should be interested in the company. Moderna has many strategic alliances: Merck, Vertex or AstraZeneca.
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