Buoyed by the success of its mRNA technology against COVID-19, BioNTech is now focused on its cancer vaccines. The company recently began dosing patients for its Phase II trial for an advanced melanoma vaccine in the European Union.
BioNTech calls itself a "next-generation immunotherapy company pioneering in therapies for cancer and other serious diseases." The COVID-19 vaccine was a minor detour for the company. The company’s product pipeline is filled with mRNA vaccines targeting different types of cancers, most of which are in preclinical stages. BioNTech recently began the Phase II trial of BNT111, which will test its mRNA vaccine in combination with an antibody-drug, Libtayo, in patients with anti-PD1-relapsed Stage III/ IV melanoma. Libtayo is the commercial name for cemiplimab, co-developed by Regeneron and Sanofi, and is an anti-PD-1 monoclonal antibody.
BNT111 encodes four tumor-associated antigens: NY-ESO-1, MAGE-A3, tyrosinase, and TPTE. BioNTech claims that 90% of melanoma patients express at least one of these antigens. BNT111 is one of the many cancer vaccine candidates designed by BioNTech under its FixVac platform. FixVac consists of a fixed combination of mRNA encoded tumor-specific antigens delivered to specifically target dendritic cells. By evoking a strong immune response against these antigens, FixVac candidates help the body target cancerous cells that overexpress these antigens.
The open-label Phase II trial aims to recruit a total of 120 patients from Spain, Germany, Italy, Poland, the US, the UK, and Australia after regulatory review. Apart from safety, the trial aims to evaluate the duration of the response of the combination of the vaccine and antibody and when administered as single agents. The Phase II trial was initiated after demonstrating the safety of the vaccine in 89 patients during the Phase I trial. Results published in Nature in July 2020 show that BNT111 is a single agent and when in combination with anti-PD-1 antibody, mediates activation and expansion of tumor-specific CD4+ and CD8+ T cells.
Özlem Türeci, M.D, the co-founder and Chief Medical Officer of BioNTech, says “With the start of our Phase 2 trial, we continue on our initial path to realizing the potential of mRNA vaccines for cancer patients.”