Vaccine Info

BNT111 Melanoma Vaccine

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Last reviewed
July 10, 2021
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BNT111 Melanoma Vaccine Description

BNT111 Melanoma vaccine candidate is based upon BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer.

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

The FixVac platform candidates consist of a fixed combination of mRNA-encoded non-mutated antigens shared within specific cancer types. They feature BioNTech'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.

On June 18, 2021, Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech, stated in a press release, “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 realizing the potential of mRNA vaccines for cancer patients.”

BioNTech retains global commercial rights to BNT111 and is not encumbered by the Pfizer-BioNTech COVID-19 vaccine program.

Mainz, DE-based Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. BioNTech US is the North American headquarters, based in Cambridge, MA.

BNT111 Melanoma Vaccine Indication

BNT111 in combination with Libtayo (cemiplimab) is being studied in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma.

BNT111 Melanoma Vaccine News

June 18, 2021 - BioNTech Announces First Patient Dosed in Phase 2 Clinical Trial of mRNA-based BNT111 in Patients with Advanced Melanoma.

August 29, 2020 - The Phase 1 Lipo-MERIT dose-escalation trial 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 showed that BNT111 mediated durable responses both as a single agent and in combination with anti-PD-1 antibodies and that durable objective response by BNT111 were associated with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells.

July 29, 2020 - The journal Nature published a study: An RNA vaccine drives immunity in checkpoint-inhibitor-treated melanoma. 'Our findings indicate that RNA-LPX vaccination is a potent immunotherapy in patients with CPI-experienced melanoma, and suggest the general utility of non-mutant shared tumor antigens as targets for cancer vaccination.'

BNT111 Melanoma Vaccine Clinical Trials

BNT111 is currently conducting clinical trials. 

A phase 1 clinical trial 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 that durable objective response by BNT111 were associated with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells. Results were published in Nature in July 2020.

The Phase 2 trial 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 observed in patients with melanoma who had progressed following prior checkpoint blockade.