(BFM Bourse) – The Nantes biotechnology company announced Thursday evening that it had received compassionate access authorizations in three European countries for its potential therapeutic vaccine against non-small cell lung cancer. The group has also scheduled a meeting with the US health authority to approve the protocol for the phase 3 confirmatory pivotal trial.
While the Paris Stock Exchange is experiencing a difficult Friday, OSE Immunotherapeutics is sailing against the prevailing gloom. The action of the biotechnology company based in Nantes jumped, taking nearly 30% to 6.56 euros around 2:30 p.m., thanks to an encouraging update for Tedopi, its most advanced molecule.
OSE Immunotherapeutics is developing this therapeutic vaccine as a potential treatment for non-small cell lung cancer (NSCLC) after failure of immunotherapy. NSCLC represents 85% to 90% of all lung cancers in Europe.
It is for this indication that the company announced Thursday evening that it had obtained compassionate access authorizations from health agencies in France, Italy and Spain. This type of access allows the use of medicines without marketing authorization for a given patient in the event that these medicines meet an uncovered therapeutic need. These authorizations are issued at the request of doctors.
“Convincing” clinical trial results
OSE Immunotherapeutics has also indicated that it has filed an official request for a “Type C meeting” with the Food and Drug Administration, the American health authority. This request should enable validation of the new protocol for its pivotal phase 3 confirmatory trial – the last step before potential marketing – evaluating Tedopi as a second-line treatment for NSCLC after failure of immunotherapy. In Europe, the company has already received recommendations (“Scientific Advice”) from the European Medicines Agency (EMA).
This new confirmatory trial will follow a first phase 3 trial whose final clinical results published Thursday evening were deemed “convincing” by the company.
“The final results of the first phase 3 study evaluating Tedopi to treat lung cancer show that we have, for the first time, an effective therapeutic vaccine in patients in treatment failure”, explains to BFM Bourse doctor Nicolas Poirier, appointed CEO of OSE Immunotherapeutics earlier this month.
“Tedopi showed better survival results, better quality of life and a better toxicity profile compared to chemotherapy, which remains the reference treatment,” he adds.
Following these announcements, Degroof Petercam confirmed its buy recommendation on the stock, with a target price of 15 euros. The financial intermediary particularly appreciates the announcement of the registration of the application with the FDA. Degroof Petercam estimates that sales of Tedopi could ultimately peak at around 300 million euros.
OSE Immunotherapeutics is conducting additional Phase 2 clinical trials evaluating Tedopi for other indications, namely pancreatic cancer and ovarian cancer.
Julien Marion – ©2022 BFM Bourse
Are you following this action?
Receive all the information about OSE IMMUNO in real time: