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BioNTech’s Phase 2 Trial for mRNA-based Cancer Shot

BioNTech has initiated a Phase 2 clinical trial for its mRNA-based cancer vaccine, BNT111, in patients with advanced melanoma. The trial is evaluating the therapeutic cancer vaccine candidate BNT111 in combination with Libtayo (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma. BNT111 is the lead product candidate from BioNTech’s FixVac platform, which targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer. The study is based on positive results from the Phase 1 Lipo-MERIT trial that demonstrated a favorable safety profile for BNT111 as well as durable objective responses 1.

BioNTech’s Vision and Focus
BioNTech’s vision is to harness the power of the immune system against cancer and infectious diseases. The company aims to demonstrate the potential of mRNA vaccines in addressing COVID-19 while not forgetting that cancer is also a global health threat 1.

Other Initiatives and Trials
In addition to the Phase 2 trial for BNT111, BioNTech is also involved in other trials for mRNA-based cancer vaccines. For instance, the company has started a Phase 2 trial for autogene cevumeran, developed with the Genentech unit of Swiss pharma giant Roche, as an adjuvant treatment for colorectal cancer and as a first-line option for advanced melanoma in combination with Merck’s PD-1-blocking antibody, pembrolizumab 2

Furthermore, BioNTech has expanded its clinical oncology portfolio with the first patient dosed in a Phase 2 trial of mRNA-based individualized immunotherapy BNT122 in colorectal cancer patients 3.

BioNTech’s efforts in developing mRNA-based cancer vaccines demonstrate the company’s commitment to leveraging its expertise beyond COVID-19 to address other critical health challenges, such as cancer. The initiation of Phase 2 trials for various mRNA-based cancer vaccine candidates reflects the company’s dedication to advancing innovative treatments in the field of oncology.