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BioNTech Reports Positive Data From MRNA-based BNT111 FixVac Melanoma Trial

BioNTech SE (BNTX) said that preliminary phase 1 results from Lipo-MERIT trial with data from 89 patients highlight favorable tolerability profile of BNT111 in advanced melanoma patients. BNT111 is the company's FixVac cancer vaccine program.

The company noted that efficacy analysis in a subset of 42 checkpoint-inhibitor (CPI)-experienced metastatic melanoma patients showed that BNT111 mediates durable responses both as a single agent and in combination with anti-PD-1 antibodies.

Durable objective responses by BNT111 were associated with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells, the company said in a statement.

BioNTech's FixVac platform candidates consist of a fixed combination of mRNA-encoded non-mutated antigens shared within specific cancer types. They feature the Company's proprietary RNA-lipoplex delivery formulation which is designed to enhance stability and translation of the mRNA cargo as well as specifically target dendritic cells to trigger a strong and precise innate and adaptive immune response against cancer cells overexpressing the respective antigen.

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