OSE Immunotherapeutics has received non-dilutive funding from Bpifrance – Direction Régionale de Nantes to develop a companion diagnostic test for a Phase III trial of the Tedopi vaccine as a second-line treatment of non-small cell lung cancer (NSCLC).
The €1.5m ($1.63m) funding was provided as part of the R&D Innovation Loan programme.
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It expects to advance the development of a new companion diagnostic test that involves a simple blood sample.
This diagnostic is a test for a predictive immunological biomarker to recognise HLA-A2 genotype patients who biologically respond to Tedopi.
It will be used to enrol the patient subpopulation in the proposed registration Phase III trial of Tedopi.
This final clinical development stage aims to verify the efficacy and safety of Tedopi in second-line treatment post-immune checkpoint inhibitor failure in NSCLC patients who are HLA-A2 positive.
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By GlobalDataOSE Immunotherapeutics CEO Nicolas Poirier said: “We warmly thank Bpifrance – Direction Régionale de Nantes for funding the development of this unique companion diagnostic test to accelerate the final clinical development phase of our cancer vaccine Tedopi in preparation to support the regulatory registration in advanced NSCLC for the HLA-A2 patient subpopulation.”
NSCLC is estimated to account for 85% of all lung cancers and the HLA-A2 phenotype represents nearly 45% of the population.
Annually, up to 100,000 patients could benefit from Tedopi in seven major markets across Europe, China Japan and the US.
Tedopi, which already obtained an orphan drug status designation in the US, is considered a precision medicine for patients with HLA-A2 in Europe.
