On June 20, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported that the Company has received €1.5 million in non-dilutive funding from Bpifrance – Direction Régionale de Nantes (Press release, OSE Immunotherapeutics, JUN 20, 2023, View Source [SID1234632809]). 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.

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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 hence 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.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "We warmly thank Bpifrance – Direction Régionale de Nantes for funding the development of this unique companion diagnostic test to accelerate the final clinical development phase of our cancer vaccine Tedopi in preparation to support the regulatory registration in advanced NSCLC for the HLA-A2 patient subpopulation".