OSE Immunotherapeutics completes enrollment in lung cancer trial

NANTES, France/ROME - OSE Immunotherapeutics (market cap: $161.64M) and the FoRT Foundation announced Thursday they have completed patient enrollment in a Phase 2 clinical trial evaluating cancer vaccine Tedopi in combination treatments for non-small cell lung cancer (NSCLC).

The Combi-TED study enrolled 105 HLA-A2 positive patients across sites in Italy, France and Spain. The trial is exploring Tedopi combined with either nivolumab (an anti-PD1 checkpoint inhibitor) or docetaxel, compared to docetaxel alone as second-line treatment for metastatic NSCLC following first-line chemo-immunotherapy.

The open-label, randomized, three-arm study will measure one-year survival rate as its primary endpoint. Top-line results are expected in the second half of 2026.

"We are very pleased to announce the completion of enrollment in Combi-TED, an exploratory Phase 2 evaluating a new treatment strategy with the combination of therapeutic cancer vaccine Tedopi which, by activating T lymphocytes, might efficiently optimize a checkpoint inhibitor or chemotherapy treatment," said Federico Cappuzzo, Director Medical Oncology at Cancer Institute Regina Elena in Rome and Chief Investigator of the study.

The trial focuses on patients with metastatic NSCLC who have no evidence of EGFR mutations or ALK or ROS1 rearrangement, and who have progressed after at least three months of first-line chemo-immunotherapy. According to InvestingPro data, OSE Immunotherapeutics maintains excellent financial health with a strong current ratio of 3.46, indicating robust operational stability for its research programs.

This study runs parallel to the ARTEMIA pivotal trial, which is investigating Tedopi as a monotherapy compared to docetaxel in a different NSCLC patient population with secondary resistance to immune checkpoint inhibitors.

OSE Immunotherapeutics, quoted on Euronext, is a biotechnology company focused on developing first-in-class therapies in immuno-oncology and immuno-inflammation. The company has demonstrated remarkable financial performance, with InvestingPro analysis showing impressive revenue growth and strong profitability in the last twelve months. Discover 8 more exclusive financial insights and metrics with an InvestingPro subscription.

According to the press release statement, the Combi-TED trial will provide additional information on Tedopi’s potential when administered in combination as a second-line treatment in a broader metastatic NSCLC population.

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