NEW YORK – OSE Immunotherapeutics on Tuesday said it is starting a global, Phase III clinical trial to test the activity of its neoepitope-based cancer vaccine Tedopi as a second-line treatment for HLA-A2-positive metastatic non-small cell lung cancer.
The Nantes, France-based firm is evaluating the off-the-shelf vaccine in a registration-directed trial, dubbed Artemia, which will take place in the US, Canada, Europe, and the UK. Health agencies in 14 countries have granted OSE permission to conduct the trial, data from which the firm will submit to regulators in Europe and North America.
In Artemia, OSE will compare Tedopi against the standard of care in 363 NSCLC patients with secondary resistance to immune checkpoint inhibitors, which is defined as resistance after at least 12 weeks of immunotherapy maintenance treatment without cytotoxic therapy.
OSE is also evaluating a companion diagnostic for determining HLA-A2 positivity in eligible patients. In 2023, the firm partnered with GenDx to develop this next-generation sequencing-based CDx to identify patients with the HLA-A*02 genotype who are likely responders to Tedopi epitopes.
In addition to this registration trial, OSE is testing Tedopi in a Phase III trial in third-line NSCLC.