Melanoma is a malignant cancer that occurs in pigment producing skin cells (melanocytes). Although its exact cause is still unknown, research has shown that UV radiation can increase the risk of developing melanoma. It is highly aggressive and metastatic but still treatable if detected in the early stage.
Currently, the gold standard for melanoma treatment is surgical excision. Surgeons also remove some excess area around the margin of the cancer and affected lymph nodes. The surgery may be followed by radiation, chemotherapy, or immunotherapy to make sure nothing remains. However, sometimes the tumor becomes unresectable by surgery and difficult to treat.
Enter BioNTech (of Pfizer fame)
BioNTech has been involved in mRNA vaccine research due to the COVID-19 pandemic and has created one of the most successful vaccines in the world i.e. Pfizer. Recently, they announced the start of their phase 2 trial for a vaccine called BNT111, created to treat patients with advanced melanoma.
“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“.– Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech
The trial, set to enroll 120 melanoma patients from Spain, Germany, Italy, Poland, UK, US, and Australia, has already inoculated their first participant. The researchers designed it as a randomized nonblinded trial that will run for 24 months. It aims to study the safety and efficacy of the BNT111 vaccine in combination with an immunotherapeutic anti-PD-1 monoclonal antibody called Libtayo (cemiplimab), developed by Regeneron, who is also collaborating in the trial. This is a follow-up to the phase 1 trial in which the vaccine showed a good response and safety profile.
Along with the BNT111 vaccine, the company is also starting phase 2 trials for 2 other mRNA vaccinations. These include BNT113 which aims to treat HPV-positive head and neck cancers, and BNT114, aimed at triple negative breast cancer. The vaccines are part of a platform they call “FixVac”, one of BioNTech’s many projects aimed at treated cancers.