On November 21, 2023 OSE Immunotherapeutics reported 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 (Press release, OSE Immunotherapeutics, NOV 21, 2023, View Source [SID1234637924]). 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.
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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.".
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.