BioNTech’s melanoma vaccine shows promise in early interim analysis

pharmafile | July 30, 2020 | News story | Research and Development BioNTech, Cancer, pharma 

While the company has more recently drawn headlines for its COVID-19 efforts, BioNTech has unveiled promising interim Phase 1 data for its mRNA-based cancer vaccine BNT111, the most advanced  of the company’s five FixVac candidates, in patients with stage 3 B-C and stage 4 melanoma.

Through analysis of repeated intravenous doses ranging from 7.2µg to 400µg, the company said that the therapy “mediates durable objective responses” both as a monotherapy and in combination with PD-1 checkpoint blockade.

The trial examined the therapy’s efficacy in a subset of 42 checkpoint-inhibitor (CPI)-experienced melanoma patients assessed by imaging of metastatic lesions before and after vaccination. BioNTech said that vaccination “resulted in the expansion and activation of circulating tumour-antigen-specific T cells with memory-function that exhibited strong cytotoxic activity against tumour cells.” 

These T cells were also shown to exhibit a Th1 phenotype, and, with continuous monthly vaccination, persisted for over a year.

At the time of analysis, three of the 25 patients receiving BNT111 alone saw a partial response, seven saw their disease stabilise, and one patient achieved complete metabolic remission of metastatic lesions. Furthermore, six of the 17 patients receiving BNT111 in combination with anti-PD-1 achieved a partial response.

The company said that the candidate was well tolerated with no dose limiting toxicity. It is currently also progressing FixVac candidates through Phase 1 studies in prostate, ovarian and triple negative breast cancer, as well as HPV16-positive cancers.

Matt Fellows

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