OSE Immunotherapeutics SA announced that the Company has received EUR 1.5 million in non-dilutive funding from Bpifrance- Direction Regionale de Nantes. The "R&D Innovation Loan" program aims at supporting the development of a companion diagnostic for the pivotal Phase 3 clinical trial of Tedopi®? in NSCLC second line treatment.

The funding from Bpifrance aims at accelerating the development of an innovative companion diagnostic test based on a simple blood sample. The companion diagnostic is a unique test for a predictive immunological biomarker to identify patients with HLA-A2 genotype who are biological responders to Tedopi®?. The companion diagnostic will be used for the enrolment of the patient subpopulation in the upcoming registration pivotal Phase 3 of Tedopi®?.

the objective of this final clinical development stage is to confirm the efficacy and safety of Tedopi®? In second line treatment post-immune checkpoint inhibitor (ICI) failure in HLA-A2 positive NSCLC patients. NSCLC accounts for 85% of all lung cancers and the HLA-A2 phenotype represents about 45% of the population.

Based on selection of patients after ICI failure data, the targeted population for Tedopi®? in second line is considered as rare with high unmet medical needs. Up to 100,000 patients per year are estimated to potentially benefit from Tedopi®?

in 7 major markets across the US, Europe, China and Japan. Tedopi®? has obtained an orphan drug status designation in the United States and is considered as a precision medicine in Europe for HLA-A2 positive patients.