Propelled on the stock market, the Nantes biotech has announced that it has received compassionate access authorizations in three European countries for its therapeutic vaccine candidate Tedopi against non-small cell lung cancer. The company has requested a meeting with the FDA and announces the preparation of a pivotal confirmatory Phase 3 trial.
Ose Immunotherapeutics advances with Tedopi in lung cancer, the Stock Exchange applauds | Photo credits: iStock
This is what gives balm to the heart at Ose Immunotherapeutics and in patients. Three European health agencies, in France, Italy and Spain, will soon allow patients suffering from non-small cell lung cancer (NSCLC) at the advanced or metastatic stage, and in failure of immunotherapy, to be treated with Tedopi at “ compassionate title “. A third-line treatment, after chemotherapy and immunotherapy, indicates the biotech.
On the stock market, the title was propelled from the opening. In the afternoon, he gained another 28.4% to 6.55 euros. Ose Immunotherapeutics’ most advanced product, Tedopi is a therapeutic vaccine based on neo-epitopes, a patented combination of nine neo-epitopes selected and optimized from five tumor antigens to specifically activate T lymphocytes as well as an epitope stimulating the ‘helper’ function of T lymphocytes.
Request for a meeting with the FDA
The French, Italian and Spanish authorizations were granted on the basis of the phase 3 clinical trial, the results of which demonstrated a significant improvement in overall patient survival, a better tolerance profile and a better quality of life.
Encouraged by this progress, Ose Immunotherapeutics requested a meeting – “Type C meeting” – with the American health authority (FDA) to validate the new protocol of its pivotal phase 3 confirmatory trial – last step before possible marketing – in people suffering from NSCLC, but in second line, this time, after failure of immunotherapy. ” Ose Immunotherapeutics has already received ‘Scientific advice’ from the European Health Agency for this target population “, adds the biotech, which has strengthened the global intellectual property of Tedopi until 2038 with patents granted in 2022 in Europe, the United States, China and Japan. ” These patents protect the innovative manufacturing process of a ready-to-use emulsion validated for a combination of peptides “, adds Ose Immunotherapeutics. Currently, Tedopi is evaluated in NSCLC but also pancreatic and ovarian cancer.
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