Tedopi (formerly known as OSE-2101), is a cancer vaccine being developed by OSE Immunotherapeutics for the treatment of certain types of lung cancer. It contains a combination of 10 optimized neo-epitopes, which are parts of proteins that structurally alter cancer cells and trigger strong immune responses against them.
How Tedopi works
The epitopes present in Tedopi are optimized from five tumorous antigens. The epitopes express a minimum of one of the tumor antigens and generate a specific response from cytotoxic (aka killer) T-cells against cancer cells. Tedopi works by stimulating killer T-cells, enabling them to spot and eliminate cancerous cells, which is a key process in the treatment of disease.
Tedopi in clinical trials
The effectiveness of Tedopi in comparison with other standard treatment options in treating patients with HLA-A2 positive stage 3B non-small cell lung cancer (NSCLC) is being investigated in a Phase 3 clinical trial (NCT02654587). The main goal of the trial is to determine whether Tedopi is more effective than standard treatment options such as Taxotere (docetaxel) and Alimta (pemetrexed) in patients with advanced NSCLC who cannot be treated with radiotherapy and already had received one or two prior lines of therapy.
One of the major goals of the trial is to measure the improvement in the overall survival rate followed by progression-free survival and objective response rate (the proportion of patients who succeed in achieving a partial or complete response to treatment). In a June 2017 anouncement, OSE stated it had temporarily halted patient recruitment owing to the emerging benefit/risk balance of experimental treatment. A complimentary review of the study is underway and a decision is expected by the end of 2017 about whether or not the trial will continue.
However, the results of an earlier Phase 2 trial showed that Tedopi was effective in treating NSCLC as it helped increase patients’ relative survival rates.
Apart from NSCLC, OSE also is planning to investigate Tedopi for the treatment of locally advanced metastatic pancreatic cancer in a Phase 2 clinical trial. The trial will be conducted in partnership with GERCOR, a not-for-profit oncology physician network operating in France. The study will investigate the effectiveness of Tedopi alone or in combination with a PD-1 checkpoint inhibitor, versus standard chemotherapy in patients with stable disease.
Tedopi has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and is recognized as a personalized medicine for the treatment of HLA-A2 positive NSCLC patients in Europe.
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HLA-A2+ patients with locally advanced (Stage IIIB) .