OSE Immunotherapeutics (OSE) Status update summary

Pipeline and clinical development overview

• Tedopi, a ready-to-use immunotherapy vaccine, has treated over 700 patients and is in advanced clinical development for non-small cell lung cancer (NSCLC) and ovarian cancer.

• Lusvertikimab, another proprietary asset, showed positive phase II results in ulcerative colitis and is advancing toward a new indication, chronic pouchitis.

• Multiple investigator-sponsored studies are ongoing, including a recent ovarian cancer trial presented at ASCO.

NSCLC treatment landscape and unmet needs

• NSCLC remains the leading cause of cancer-related death, with most cases diagnosed at an advanced stage and a five-year survival rate of only 28%.

• Immunotherapy has improved outcomes, but only a minority of patients achieve long-term survival, and most do not respond durably.

• Standard second-line therapy, docetaxel, offers poor efficacy and significant toxicity, highlighting the need for better options.

Tedopi clinical data and trial updates in NSCLC

• Tedopi targets HLA-A*02 positive NSCLC patients, representing about 45% of the population, and is administered subcutaneously every three weeks.

• Phase II data showed a median overall survival of 17.3 months in pre-treated patients, with survival correlating to immune response against neoepitopes.

• The phase III ATALANTE-1 trial, stopped early due to COVID-19, showed Tedopi improved overall survival (11.1 vs. 7.5 months; HR 0.59) and had a better safety profile than docetaxel.

• ARTEMIA, a new phase III trial, is ongoing in a refined population with secondary resistance to checkpoint inhibitors, using overall survival as the primary endpoint.