OSE Immunotherapeutics Advances Pipeline With Phase 3 Tedopi Enrollment On Track

Clinical-stage biotechnology company OSE Immunotherapeutics reported a cash position of €11.1 million as of June 30, 2026, while highlighting progress across its oncology and immunology pipeline and reaffirming funding expected to support operations through December 2026.

The France-based company continues to engage with institutional investors in the United States and Europe as part of efforts to secure financing beyond upcoming development milestones. As part of these financing efforts, OSE has postponed the publication of its first-half 2026 financial results.

Among its lead programs, enrollment in the Phase 3 ARTEMIA trial evaluating Tedopi for non-small cell lung cancer remains on track for completion by the end of December 2026. The study’s planned interim futility analysis is now expected in early 2027 rather than late 2026 because patient deaths have occurred more slowly than originally anticipated. According to the company, the analysis is event-driven and the lower-than-expected number of death events has delayed the timing of the review.

OSE also highlighted an upcoming clinical data presentation for Tedopi. Topline results from the Phase 2 Combi-TED international trial, sponsored by the Foundation for Research and Technology (FoRT), evaluating Tedopi in combination with an anti-PD-1 therapy or chemotherapy as a second-line treatment for metastatic non-small cell lung cancer, will be presented by principal investigator Federico Cappuzzo, MD, PhD, at the ESMO 2026 Annual Meeting in Madrid, Spain, on October 25, 2026.

The company reported continued progress with the subcutaneous formulation of lusvertikimab, an anti-IL-7 receptor therapy being developed for inflammatory diseases. OSE expects validation of the formulation by mid-2027, which could support further clinical development in ulcerative colitis.

In addition, OSE is evaluating the potential advancement of lusvertikimab into a Phase 2 study in chronic pouchitis in 2027. The company said discussions with key opinion leaders support further evaluation of the therapy in this indication.

Chief Executive Officer Marc Le Bozec said the company’s development programs continue to advance as planned and noted that OSE has been actively engaging with investors over recent months. He added that management believes the company’s pipeline and upcoming milestones provide a basis for securing additional financing.

Upcoming Milestones

– Enrollment in the Phase 3 ARTEMIA trial of Tedopi is expected to be completed by the end of December 2026.

– An interim futility analysis of the ARTEMIA study is anticipated in early 2027.

– Validation of the subcutaneous formulation of lusvertikimab is expected by mid-2027.

– The company is evaluating a Phase 2 study of intravenous lusvertikimab in chronic pouchitis in 2027.

– Topline results from the Phase 2 Combi-TED trial evaluating Tedopi in combination with an anti-PD-1 therapy or chemotherapy in metastatic NSCLC are scheduled for presentation at the ESMO 2026 Annual Meeting on October 25, 2026.

Source link