Success for individualised cancer vaccine

German biotech company Biontech AG has published positive clinical results for its individualised cancer vaccine Ivac mutanome in patients with late-stage melanoma.


It could be the next step in individualised cancer immunotherapy. German Biontech AG announced positive phase I trial results, published in Nature, demonstrating its RNA vaccine Ivac induces immunogenicity as well as promising anti-tumour activity in high-risk patients with late-stage melanoma. The study is considered as the world’s first with a personalised mRNA vaccine. Ivac is directed against multiple neo-epitopes unique for each patient, which were identified by an analysis of the tumour tissue of the respective patient. The clinical study included 13 patients with melanoma. “Each patient developed immune responses against multiple vaccine targets. This suggests that in principle, it may be possible to train a patient’s immune system to help fight their cancer across a wide array of tumour types,” said Ugur Sahin, Founder and CEO of Biontech. Eight of the 13 patients remained tumour-free after 23 months and five patients had tumour relapses before starting neo-epitope vaccination.

However, the production of the vaccine is complex: First of all individual mutations (neo-epitopes) have to be identified in conventional tumour biopsies using next generation sequencing and a computer-assisted analysis. This method enables the prediction of potentially suitable target structures for the vaccine. Following than is the design and production of the RNA vaccine that encodes several patient-specific neo-epitopes.

Since 2016 Biontech’s Ivac platform is being developed in collaboration with Genentech, a member of the Roche Group. The companies are currently working with health authorities in the US and other countries to validate, standardise, and apply the entire process. „While our study documents early findings, additional trials are needed to further evaluate safety, clinical efficacy over time and across larger patient cohorts,” states Sahin.


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