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First cancer patient receives mRNA melanoma vaccine in new clinical trial

As research into mRNA vaccines was lifted and thrown into the limelight in the relentless fight against COVID-19, speculation began about how innovations could affect other medical fields.

Now another major milestone has been reached with the purpose of the first patient in the Phase II study 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 that both researchers and participants know which control and which is experimental) and randomized and involves 120 patients. It will evaluate the overall response rate of BNT1

1 when used in partnership with cemiplimab (Libtayo brand), as well as the duration and safety of treatment. Due to promising results from the Phase I trial, there is high hope 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 the addressing of COVID-19. We must not forget that cancer is also a global health threat, even worse than the current pandemic, ”said Özlem Türeci, MD, co-founder and Chief Medical Officer of BioNTech, in a statement.

“BNT111 has already shown a favorable safety profile and encouraging preliminary results in the early clinical evaluation. With the start of patient treatment in our Phase 2 trials, we are encouraged to continue on our original path to exploit 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 several immunotherapy treatments that contain the cellular instructions to create antigens that are shared between cancers, which are administered to patients in an attempt to induce the immune system to produce antibodies against them. By doing this, the immune system is “trained” to destroy 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 is present in over 90 percent of metastatic melanoma cases.

In addition to BNT111, BNT112 (an experimental treatment for castration-resistant prostate cancer, currently in Phase 1 trial) and BNT113 (another mRNA treatment for HPV-positive head and neck cancer, also in Phase 1 trial) are being tested to continue BioNTech’s mRNA platform. Such vaccines can make huge jumps in the survival rate of complex and advanced cancers.


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