Date: 2015-01-29
Type of information: Clinical research agreement
Compound: Tedopi®
Company: OSE Pharma (France) Simbec-Orion (UK)
Therapeutic area: Cancer - Oncology - Rare diseases
Type agreement: clinical research
Action mechanism: immunotherapy product. Tedopi® targets five tumour associated antigens (TAA), selected because their presence is linked to a poor prognosis and the severity of various cancers. Tedopi® contains ten optimized epitopes, or “neoepitopes”, designed on the binding of HLA-A2 and TCR,. These neo-epitopes generate strong specific T cytotoxic responses that fight cancer and prevent tumour escape..
Disease: HLA-A2 positive advanced non-small cell lung cancer (NSCLC) patients who have failed on previous therapy
Details: * On January 29, 2015, OSE Pharma, a biotechnology company developing T-cell specific immunotherapy, and Simbec-Orion, a leading global clinical research organisation (CRO) with specialisation in oncology and rare diseases, announced that they have entered into a collaboration agreement to conduct the upcoming Tedopi® Phase III pivotal trial in HLA-A2 positive advanced non-small cell lung cancer (NSCLC) patients who have failed on previous therapy. The protocol of this pivotal Phase III trial, which will treat advanced invasive (stage IIIb) or metastatic (stage IV) NSCLC patients who express the HLA-A2 receptor (approximately 45% of the NSCLC population), has been recently approved both by the FDA and the European Medicines Agency’s (EMA). Simbec-Orion will manage this multi-centre, multi-country study involving up to 70 sites and 500 patients in the United States and Europe.
Simbec-Orion has started the feasibility study for the planned study with international clinical experts and patient enrolment is planned for the second half of 2015. Simbec-Orion will be responsible for site selection, patient enrolment, clinical monitoring, data management, statistical analysis and regulatory affairs.
As part of the collaboration agreement, Simbec-Orion has accepted warrants giving right to equity as part of payment for a portion of its fees. OSE Pharma and Simbec-Orion believe that this will closely align both parties’ interests. OSE Pharma is also planning a new Phase II clinical trial in combination with another immunotherapy treatment in NSCLC.
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