The US Food and Drug Administration (FDA) approved the trial protocol for the registrational Phase III trial for OSE’s Tedopi in January. Image Credit: Lubo Ivanko / Shutterstock.
OSE Immunotherapeutics has received €8.4m ($9m) in non-dilutive funding from the ‘France 2030’ plan funded by the French Government.
The public funds will finance the registrational Phase III trial evaluating OSE’s cancer vaccine, Tedopi, as a second-line treatment for patients with HLA-A2 positive non-small cell lung cancer (NSCLC)HLA-A2 positive non-small cell lung cancer (NSCLC). The funds were dispersed by Bpifrance on behalf of the government as part of a research and development (R&D) innovation loan programme.
OSE plans to initiate the registrational Phase III trial in the US in Q2 this year, following the approval from ethics committees. The company also plans to file for trial protocol approval with the European Medicines Agency (EMA). It will begin trial initiation across European sites, including France, following trial protocol approval.
Tedopi is a neoepitope-based immunotherapy activating tumour-specific T-cell cancer vaccine. Apart from the planned Phase III trial, OSE also evaluated the cancer vaccine as a third-line therapy in advanced NSCLC patients in another Phase III Atalante-1 trial (NCT02654587). The study found that Tedopi led to a 41% reduction in risk of death compared to chemotherapy in patients with secondary resistance to immune checkpoint inhibitors.
Multiple companies are developing cancer vaccines for different cancers. US-based Diakonos Oncology is developing a dendritic cell vaccine, DOC1021, for malignant glioma. Earlier this year, the vaccine was awarded an orphan drug designation by the FDA. Sweden-based Mendus is developing its cancer vaccine, vividencel, for treating acute myeloid leukaemia. The vaccine was granted a fast track designation by the FDA in September 2023.