When research into mRNA vaccines was ramped up and they were thrust into the spotlight in the relentless fight against COVID-19, speculation began as to how the innovations could impact other areas of medicine.
Now, another large milestone has been reached to that end, with the first patient in the Phase II trial of the BioNTech mRNA cancer vaccine receiving their first dose. The BNT111 treatment will be combined with an existing immunotherapy drug and aims to combat a specific type of advanced melanoma.
The trial is open-label (meaning both the researchers and participants know which is control and which is experimental) and randomized, involving 120 patients. It will evaluate the overall response rate of BNT11 when used in partnership with cemiplimab (brand name Libtayo), as well as duration and safety of the treatment. Riding off of promising results from the Phase I trial, hopes are high that the treatment will elicit a strong and safe antibody response.
“Our vision is to harness the power of the immune system against cancer and infectious diseases. We were able to demonstrate the potential of mRNA vaccines in addressing COVID-19. We must not forget, that cancer is also a global health threat, even worse than the current pandemic,“ said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech, in a statement.
“BNT111 has already shown a favorable safety profile and encouraging preliminary results in early clinical evaluation. With the start of patient treatment in our Phase 2 trial, we are encouraged to continue on our initial path to realize the potential of mRNA vaccines for cancer patients.”
BNT111 is an experimental anti-cancer mRNA treatment as part of BioNTech’s FixVac platform. This involves multiple immunotherapy treatments that contain the cellular instructions to create antigens that are shared between cancer types, which are administered to patients in an attempt to induce the immune system into producing antibodies against them. Through doing so, the immune system becomes "trained" into destroying tumors before they become problematic. BNT111 is the most advanced treatment in the FixVac pipeline, and targets four antigens – at least one of these antigens are present in over 90 percent of metastatic melanoma cases.
Alongside BNT111, BNT112 (an experimental treatment against Castration Resistant Prostate Cancer, currently in Phase 1 trials) and BNT113 (another mRNA treatment against HPV-positive head and neck cancers, also in Phase 1 trials) are being tested to further BioNTech’s mRNA platform. Such vaccines could provide huge leaps in survival rates of complex and advanced cancers.