Skip to NavigationSkip to content

BioNTech's melanoma vaccine shows promise in early interim analysis

Published on 30/07/20 at 10:50am

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

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches