OSE Immunotherapeutics SA announced that the Company has entered into a collaboration with Genome Diagnostics B.V. (GenDx) to develop and validate a companion diagnostic (CDx) test to support the confirmatory pivotal Phase 3 clinical trial of Tedopi®? cancer vaccine candidate in preparation in Non-Small Cell Lung Cancer (NSCLC) second line treatment. GenDx, one of the pioneering companies in the HLA field, is developing and marketing innovative molecular diagnostics, in particular in the field of high-resolution HLA typing and related molecular diagnostic testing.

Under the Master Collaboration Agreement, GenDx will develop and validate a companion diagnostic ("CDx") unique test for a predictive immunological biomarker to identify patients with HLA-A*02 genotype who are biological responders to Tedopi®? epitopes. The CDx test, based on a simple blood sample and Next-Generation Sequencing technologies (NGS), will support the enrolment of eligible NSCLC patient in the upcoming registration pivotal Phase 3 of Tedopi®?.

The objective of this study will be to confirm the efficacy and safety of Tedopi®? in second line treatment post-immune checkpoint inhibitor (ICI) failure in HLA-A*02 positive NSCLC patients to support Tedopi®?'s registration in both United States and Europe. In June 2023, OSE Immunotherapeutics had received EUR 1.5 million in non-dilutive funding from Bpifrance - Direction Regionale de Nantes, as part of the "R&D Innovation Loan" program, to support the development of this companion diagnostic for the pivotal Phase 3 clinical trial ofTedopi®?

in NSCLC second line treatment. This upcoming clinical is planned to be conducted in the United States and in Europe.