OSE Immunotherapeutics - FDA support received for Tedopi Phase III trial
OSE has announced that it has received positive recommendations from its ‘type C’ meeting with the FDA for the planned confirmatory Phase III trial design for Tedopi (neoepitope cancer vaccine), as a second-line treatment in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure. This follows similar advice from the European Medicines Agency (EMA). The company will now undertake the pivotal trial as monotherapy (against standard of care) under this protocol, for patients with HLA-A2+ tumours (c 45% of total population). As a reminder, OSE reported positive data from the previous Phase III ATALANTE-1 trial as second/third-line treatment, although enrolment had to be terminated prematurely due to the COVID-19 pandemic.Ose Immunotherapeutics SA, formerly Orphan Synergy Europe Pharma SA, is a France-based company principally engaged in the clinical stage biotechnological sector. The Company develops immunotherapy products against invasive or metastatic late-stage cancers. The Company offers a technology, called Memopi, which helps the immune system to eliminate malignant cells; it re-educates the body's immunological memory so that the immune system (and particularly T cytotoxic cells) attacks tumor cells by increasing the patient's specific cytotoxic T response against their cancer. The Company's main product, Texopi, is a patented combination of ten epitopes, selected and optimized from five tumor associated antigens.
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