BioNTech, based in Mainz, Germany, has entered into a partnership with Pfizer worth up to $425M (€374M) to develop an mRNA-based flu vaccine, which could be produced much more quickly than current flu vaccines.
Messenger RNA (mRNA) is one of the building blocks living organisms use to create proteins from genes. BioNTech is developing prophylactic vaccines that use mRNA from flu-causing viruses instead of the inactivated virus, toxins it produces, or its surface proteins.
BioNTech’s flu vaccine will deliver mRNA from flu-causing viruses to the patient’s cells, which then use the mRNA to make its corresponding viral protein. Antibodies and white blood cells of the patient’s immune system learn to recognize the protein, which conveys immunity to the virus.
The key advantage of the mRNA approach, if proven to be effective in human trials, is that it could be used to produce a vaccine quickly in response to an emerging outbreak, something that is difficult using standard techniques for developing flu vaccines.
BioNTech will receive €106M from Pfizer upfront, with the possibility of up to €268M in milestone payments, to develop the mRNA flu vaccine. After BioNTech completes a first-in-human clinical study, Pfizer will take over the clinical development and commercialization of the flu vaccine. If the product reaches commercialization, BioNTech will receive royalty payments from Pfizer for worldwide sales.
Although mRNA’s role in protein synthesis has been known since the 1950’s, it has only been investigated for therapeutic purposes recently. Other companies are developing mRNA vaccines, such as CureVac in Germany, and Moderna Therapeutics in the US, which both have mRNA flu vaccines in development, along with other candidates.
BioNTech is also developing therapeutic vaccines for cancer and already obtained promising Phase I results for its mRNA melanoma vaccine last year. However, whether this success continues remains to be seen, as CureVac’s mRNA prostate cancer vaccine, failed at Phase II last year.
Pfizer’s interest in the company’s technology for prophylactic vaccines suggests they are confident in its potential, but we have yet to see how the mRNA technology will fare in the clinic.
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