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Clinical Trials

Date: 2015-09-09

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at the World Conference on Lung Cancer, from 6th to 9th September, in Denver, USA.

Company: OSE Pharma (France) now OSE Immunotherapeutics

Product: Tedopi® (OSE2101)

Action mechanism:

  • immunotherapy product. Tedopi® (OSE2101) 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. These five tumor antigens (HER-­2/neu, p53, CEA, MAGE-2 and MAGE-­3) are expressed in various tumors related to poor prognosis and even poorer when associated. Since February 2013, OSE2101 has been granted orphan drug status by the FDA for the treatment of NSCLC in patients expressing HLA-­A2.

Disease: advanced non-small cell lung cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details:

  • • On September 9th, 2015, OSE Pharma, a biotechnology company based in France that is developing T-specific  immunotherapy treatments against invasive and metastatic cancers, unveiled results of survival and T-specific immune response in the patients with brain metastases treated with the company’s T-specific immunotherapy presented during the World Conference on Lung Cancer, from 6th to 9th September, in Denver, USA. By design, it was possible to include patients with brain metastases to the Phase 2 study on advanced non-small cell lung cancer. The spontaneous prognosis of these patients is only a few months, and this type of metastasis is a proven sign of lung cancer’s severity. Through an analysis of the entire patient population, 6 patients with Brain Metastases were identified, out of the 64 patients treated by Tedopi® (OSE2101). These 6 patients had been heavily pretreated; in addition to brain radiotherapy, they had previously received from 1 to 3 different lines of chemotherapy. The study of survival under Tedopi® treatment (OSE2101) showed a median survival of 13.75 months, with extremes ranging from 7 months in a patient whose cancer was still progressing, to a survival exceeding 41 months – this patient was still alive at the end of the study – which are particularly interesting results for this group of patients with usually a poor prognosis. For 5 of these 6 patients, the study of immune responses showed that they had actually developed a specific T cytotoxic response to at least 1, and up to 5, of the tested epitopes included in Tedopi®. An international patent application on this particular clinical domain has also been filed in November 2014.

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