Eurobio Scientific company Genome Diagnostics (GenDx) has partnered with French biotech company OSE to develop and validate a companion diagnostic (CDx) test for an epitope-based cancer vaccine.
The collaboration aims to develop the CDx test for high-resolution typing of human leukocyte antigen (HLA)-A*02 based on GenDx’s in vitro diagnostic regulation (IVDR) registered NGSgo kit and NGSengine software.
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The test would support the ‘confirmatory pivotal’ Phase III study of the Tedopi cancer vaccine, which is under preparation as a second-line treatment for non-small cell lung cancer (NSCLC).
As part of the master collaboration agreement, GenDx will develop and validate the test for a predictive immunological biomarker. This is aimed at identifying patients with the HLA-A*02 genotype who biologically respond to Tedopi epitopes.
Based on next-generation sequencing (NGS) technology, the CDx test will support eligible NSCLC patient enrolment in the Tedopi Phase III trial.
The study aims to determine Tedopi’s efficacy and safety in second-line treatment post-immune checkpoint inhibitor failure in HLA-A*02 positive NSCLC patients to support the registration of the vaccine in both Europe and the US.
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By GlobalDataGenDx general manager Maarten Penning said: “In this project, our regulatory expertise, illustrated by being one of the first IVDR-compliant companies and our extensive knowledge of developing software and reagents for accurate high-resolution HLA typing using NGS come together in the development of a companion diagnostic assay for HLA-A*02.
“We are very happy to enter this strategic collaboration with OSE, as we aim to contribute to improving the quality of life and survival of patients.”
OSE Immunotherapeutics CEO Nicolas Poirier said: “This companion diagnostic test will be useful for selecting HLA-A02-eligible cancer patients and thus accelerating the clinical development and regulatory registration of Tedopi as a precision medicine innovative treatment.”
Last year, Eurobio Scientific acquired GenDx for $132.3m.
