OSE Immunotherapeutics Highlights Clinical Portfolio Advancements and Provides 2024 Outlook

Regulatory News:

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) updates on its clinical portfolio advancements and provides 2024 outlook.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “The Company has a broad portfolio of 5 products in clinical development with significant advances reached in 2023 and key milestones expected in 2024. Our preclinical programs are focused on 3 immunotherapy platforms, a source of innovation in immuno-oncology and inflammatory diseases linked to myeloid cells or T lymphocytes. Part of the portfolio generates revenues from existing industrial agreements and the progress of proprietary products, in clinical and preclinical stages, is a source of potential future revenue in markets with high medical needs. Our shared ambition at OSE is to create value by leading our two advanced assets in phase 2 and phase 3 to a clinical inflection point allowing a structuring agreement. Moreover, we will reinforce the partnership and recurrent revenue strategy by relying on pharmaceutical partners recognized in the relevant markets for our other first-in-class innovative programs. All of which has been put in place over the last 12 months will help advance the Company’s growth path in the coming weeks and months.”

Proprietary programs: a broad portfolio of advanced products

Tedopi, optimized epitope-based cancer vaccine

Dossier and protocol approved by the FDA (Food and Drug Administration) in mid-January to launch a new confirmatory Phase 3 clinical trial in second-line lung cancer

In September 2023, the positive results from the first Phase 3 clinical trial in third-line lung cancer with secondary resistance to immune checkpoint inhibitors (ICI) were published in Annals of Oncology. In March 2023, based on these results, compassionate use programs had been approved in France and Italy as well as an extended access made available in Spain. In July 2023, a patent was granted in the United States for the use of Tedopi in cancer after failure with ICI.

Based on the positive recommendations from the US FDA and from the European Medicines Agency (EMA) in early 2023, the Company filed a dossier to the FDA to continue the development of Tedopi in the same patient population in secondary resistance, but in second-line treatment (due to changing medical practice and earlier administration of ICI, now used in first-line treatment in combination with chemotherapy).