OSE Immunotherapeutics Announces a Collaboration Agreement with GenDx for the Development of a Companion Diagnostic for Epitope-Based Cancer Vaccine Candidate Tedopi

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced that the Company has entered into a collaboration with GenDx (a Eurobio Scientific Company, a key player in the field of specialty in vitro diagnostics) 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 ⁽¹⁾ 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.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments:

“We are very pleased to have initiated this collaboration with GenDx, the leading high-resolution HLA typing company. This companion diagnostic test is the first step to move forward in selecting HLA-A*02 eligible cancer patients and thus to accelerate the clinical development and regulatory registration of Tedopi as a precision medicine innovative treatment.”

Maarten Penning, General Manager of GenDx, says: “In this project, our regulatory expertise, being one of the first IVDR ⁽²⁾ 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 in this strategic collaboration with OSE, as we aim to contribute to improve the quality of life and survival of patients.”.