OSE Immunotherapeutics Receives €8.4 M in Public Funding to Support the Registration Phase 3 Clinical Trial of Cancer Vaccine Tedopi in Lung Cancer - Seite 2

Based on positive final survival, safety and quality of life results from the Phase 3 clinical trial in the third line of treatment in non-small cell lung cancer published in September 2023 in the internationally renowned Journal ‘Annals of Oncology’, a confirmatory pivotal Phase 3 trial in second line treatment is being prepared for launch. This trial is associated with the development of a unique companion diagnostic test (collaboration with the company GenDx) to identify positive HLA-A2 patients eligible for treatment with Tedopi.

The clinical trial application dossier to initiate the new confirmatory Phase 3 of Tedopi, including the study protocol and the specific “diagnostic companion test” dossier, was approved by the Food & Drug Administration (FDA) in mid-January 2024, which should allow the trial to start in the United States in Q2 2024, after approval from the Ethic committees. The submission of the dossier to the European Medicines Agency (single European portal) is planned in the coming weeks to extend this study to a large number of clinical investigator sites in Europe, particularly in France.

* As part of an “R&D Innovation Loan” program

The management of lung cancer is a major public health issue:

• 1^st cause of cancer mortality for all populations combined (33,100 deaths in 2018¹ in France and 1.8 million per year worldwide²).
• -2^nd most common cancer among solid tumors.
• Non-Small Cell Bronchial Cancer (NSCLC) is a serious disease with a short-term life-threatening prognosis. NSCLC represents 85% of lung cancers.
• Stage IV metastatic NSCLC: 2-year survival between 10% and 23%; 5-year survival <10%³.
• Targeted population of patients identified as responders to Tedopi⁴: HLA-A2+ patients (45% of stage IV patients with secondary resistance to anti-PD-(L)1 (approximately 50% of patients failing immunotherapy in NSCLC).
  
  

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2. WHO. Globocan 2020 Fact Sheet
3. Detterbeck, F. C., Boffa, D. J., Kim, A. W., & Tanoue, L. T. (2017). The Eighth Edition Lung Cancer Stage Classification. Chest, 151(1), 193-203. https://doi.org/10.1016/j.chest.2016.10.010
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