NEW YORK – Dutch molecular diagnostics firm GenDx, a Eurobio Scientific company, said on Tuesday that it has inked a collaboration with French biotech company OSE Immunotherapeutics to develop and validate a companion diagnostic (CDx) test for high-resolution typing of HLA-A*02 based on its IVDR-registered NGSgo kit and NGSengine software.
The CDx will support the Phase III clinical trial of Tedopi, a cancer vaccine developed by OSE as a second-line treatment for non-small cell lung cancer.
Under the agreement, GenDx will develop and validate a next-gen sequencing-based CDx to identify patients with the HLA-A*02 genotype who are biological responders to Tedopi epitopes and are eligible to enroll in the trial.
According to GenDx, the objective of the trial will be to confirm the efficacy and safety of Tedopi as a second-line treatment after immune checkpoint inhibitor failure in HLA-A*02 positive NSCLC patients to support Tedopi’s registration in both the US and Europe.