US Biotech Unicorn Steps up Competition for BioNTech’s mRNA Personalized Cancer Vaccine

moderna biontech personalized cancer vaccine

Moderna Therapeutics has started dosing patients with an mRNA-based personalized cancer vaccine that resembles another one being developed by BioNTech.

Moderna Therapeutics has announced the start of a Phase 1 study with mRNA-4157, a therapy consisting of a cancer vaccine that is tailored to each patient’s individual tumor.

In order to make this personalized treatment, the company uses next generation sequencing to identify cancer mutations, called neoepitopes, that are present on tumoral cells but not healthy ones. Moderna then predicts which neoepitopes will elicit the strongest immune response against the tumor.  Twenty of these patient-specific mutations are selected and encoded into mRNA, which is used by the body to create its own cancer vaccine.

The therapy will be tested in up to 90 patients divided into two different study parts. Part A will recruit patients whose tumor has been removed by surgery and are free of cancer, whereas part B will test mRNA-4157 in combination with the checkpoint inhibitor Keytruda (pembrolizumab) in cancer patients whose tumors cannot be removed by surgery.

biontech mrna personalized cancer vaccine

Moderna is not the first one to test this type of therapy in humans. The German biotech BioNTech completed a Phase 1 study earlier this year using a very similar approach, in which 10 patient-specific mutations were identified and used to manufacture individualized cancer vaccines for patients with relapsing melanoma. BioNTech’s study was much smaller than the one Moderna is planning. It recruited only 13 patients, but it yielded remarkable results.

Like Moderna, BioNTech is also planning on combining mRNA cancer vaccines with checkpoint inhibitors. The rationale behind it is that while the mRNA vaccine guides the immune system against cancer cells, the checkpoint inhibitors remove the brakes of the immune system to make the response stronger. While Moderna is partnered with MSD to use Keytruda, BioNTech is preparing to use Tecentriq (atezolizumab), from its partner Genentech, in future trials.

Although BioNTech was the first to bring an mRNA-based personalized cancer vaccine to the clinic, Moderna Therapeutics has the resources to overtake it in terms of speed, given it has raised a huge $1.2Bn since its foundation in 2011, a figure BioNTech is nowhere close to. However, it remains to be seen how well each of them will perform in the clinic and on different types of tumors.


Images via Africa Studio /Shutterstock; BioNTech

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