OSE Immunotherapeutics Announces a Collaboration Agreement with GenDx for the Development of a Companion Diagnostic for Epitope-Based Cancer Vaccine Candidate Tedopi - Seite 2

In June 2023, OSE Immunotherapeutics had received €1.5 million in non-dilutive funding from Bpifrance - Direction Régionale 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 of Tedopi in NSCLC second line treatment. This upcoming clinical is planned to be conducted in the United States and in Europe.

⁽¹⁾ NSCLC accounts for 85% of all lung cancers and the HLA-A*02 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-A*02 positive patients.

⁽²⁾ IVDR = In Vitro Diagnostic Regulation

About HLA-A*02
The Human Leukocyte Antigen (HLA) system comprises a diverse family of genes and allelic variants crucial for the human immune system, existing in most human cell types and interacting with T cell receptors (TCRs) to activate T cells, inducing adaptive immune responses. HLA typing enables the identification of specific nucleotide sequences. HLA-A*02 is one of the most common Major Histocompatibility Class I molecules in humans (about 45% of the NSCLC patient population). HLA-A*02 system presents tumor antigens as A2 epitopes to T cells to facilitate the immune system to recognize tumor allowing a potent activation of the protective specific CD8+ T cells.

About GenDx, a Eurobio Scientific company
Genome Diagnostics B.V., trading as GenDx, is a Dutch company specializing in molecular diagnostics. It focuses on the development, production, and sales of innovative assays and analysis software for transplantation and companion diagnostics. GenDx offers a range of HLA sequencing-based typing strategies, reagents, software, and custom laboratory services and is one of the first companies being IVDR compliant. GenDx Education also provides dedicated training courses worldwide for professionals in tissue typing, research laboratories, blood banks, and donor registries.