mRNA Skin Cancer Vaccine Candidate Launches Phase Two Study

BioNTech BNT111 Phase 2 cancer vaccine candidate initiates a clinical study in Europe
protecting skin from the sun
Germany (Vax Before Cancer)

BioNTech SE announced that the first patient in Europe had been treated in its BNT111 Phase 2 cancer vaccine trial. 

The study evaluates the Company’s therapeutic cancer vaccine candidate BNT111 in combination with Libtayo® (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III-IV melanoma. 

BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens to trigger a strong and precise immune response against cancer.

“Our vision is to harness the power of the immune system against cancer and infectious diseases. As a result, we were able to demonstrate the potential of mRNA vaccines in addressing COVID-19. However, we must not forget that cancer is also a global health threat, even worse than the current pandemic,“ said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech, in a press release issued on June 18, 2021.

“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 realizing the potential of mRNA vaccines for cancer patients.”

The BNT111-01 trial conducted in collaboration with Regeneron was reviewed and approved by the regulatory authorities in Spain, Germany, Italy, and Poland and the United Kingdom, the United States, and Australia. 

The open-label randomized trial evaluates the efficacy, tolerability, and safety of BNT111 in combination with Libtayo, an anti-PD-1 monoclonal antibody, being co-developed by Regeneron and Sanofi. 

The trial is enrolling a total of 120 patients and will evaluate the effects of the combination and single agents alone. The primary endpoint is the overall response rate of BNT111 in combination with Libtayo. Secondary endpoints include overall response rate in the single-agent arms, duration of response, and safety. 

BNT111 is an intravenous therapeutic cancer vaccine candidate encoding a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as an RNA-lipoplex formulation.

Melanoma is less common than some other types of skin cancer, but it is more likely to grow and spread. The type of treatment oncologists recommends depends on the stage and location of the melanoma. But other factors can be important as well, such as the risk of cancer returning after treatment, if the cancer cells have certain gene changes and your overall health, says

More than 90% of melanomas in patients express at least one of the four tumor-associated antigens encoded in BNT111 (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE). BNT111 is one of the most advanced of five clinical-stage FixVac product candidates within BioNTech’s development pipeline.

This Phase 2 clinical trial is based on the previous Phase 1 Lipo-MERIT dose-escalation trial (NCT02410733) that demonstrated a favorable safety profile in 89 patients with advanced melanoma. 

In addition, efficacy analysis of the Lipo-MERIT study in a subset of 42 metastatic melanoma patients previously treated with a checkpoint-inhibitor (CPI) showed that BNT111 mediated durable responses both as a single agent and in combination with anti-PD-1 antibodies and those durable objective responses by BNT111 were associated with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells.

BioNTech’s FixVac platform candidates consist of a fixed combination of mRNA-encoded non-mutated antigens shared within specific cancer types. In addition, they feature the Company’s proprietary RNA-lipoplex delivery formulation, which is designed to enhance stability and translation of the mRNA cargo and specifically target dendritic cells. 

Thus, the vaccine candidate aims to trigger a strong and precise innate and adaptive immune response against cancer cells overexpressing the respective antigen.

Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech confirmed it retains global commercial rights to BNT111.

Vax-Before-Cancer publishes research-based oncology news.