COVID vaccine maker BioNTech launches phase 2 cancer vaccine trial

CANCER DIGEST – June 19, 2021 – BioNTech, the maker of the Pfizer COVID-19 vaccine, has turned its mRNA-based vaccine technology to cancer and has launched a phase 2 clinical trial to treat patients with relapsed melanoma that can’t be treated surgically.

The first dose of the BNT111 vaccine was given in combination with cemiplimab (Libtayo), a monoclonal antibody drug, in patients with melanoma that has not responded to other treatments. The clinical trial will enroll 120 patients to evaluate the effects of the combination treatment as well as the vaccine and Libtayo drug alone.
The goal of the trial is to determine the overall response rate of BNT111 by itself and in combination with Libtayo. Response rate refers to the drug’s affect on the cancer – does it reduce it, if so by how much and for how long.

The vaccine is given intravenously and much like the company’s COVID-19 vaccine, BNT111 is designed to rev up the immune system to attack cancerous melanin cells. It works by exposing the immune system to four toxins or antigens produced specifically by cancerous melanoma cells. The immune system responds by multiplying the cancer killing cells that recognize those antigens to mount a full-scale attack on them.

“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,“ said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech in a press release.

"We must not forget, that cancer is also a global health threat, even worse than the current pandemic. 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.”

The phase 2 trial follows an earlier phase 1 safety trial (NCT02410733) in 89 patients that showed BNT111 was safe and produced durable responses and produced a strong expansion of tumor-killing T-cells, the body’s defenders against foreign invaders. The results of that earlier study were published in the July 2020 journal Nature.

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Source: BioNTech press release