OSE wins French govt grant for Phase III trial for cancer vaccine
11 Apr 2024
Phase 3VaccineFast TrackPhase 2Orphan Drug
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Source: Pharmaceutical Technology
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.
The US Food and Drug Administration (FDA) approved the registrational Phase III trial protocol in January 2024. The company also concurrently filed for FDA approval for the companion diagnostic test for Tedopi, developed by Genome Diagnostics.
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.
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OSE is also conducting three Phase II trials evaluating Tedopi as a combination therapy in solid tumours such as pancreatic, ovarian and lung cancers. Data from the Phase II trials (NCT04713514 and NCT04884282) for Tedopi in combination with MSD’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab), respectively, is expected in 2025.
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.
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