(News Bulletin 247) – The Nantes biotechnology company has published positive final results for Tedopi, its therapeutic vaccine candidate against advanced lung cancer. The study shows positive effects on life expectancy and quality of life of patients compared to chemotherapy.

Fighting cancer with a vaccine was, until a few years ago, the stuff of science fiction. Except that the latest developments in this area give credibility to this possibility. Several laboratories are involved in this race. Moderna presented promising results for its intermediate phase study in skin cancer while BioNtech revealed results, at an earlier stage, also encouraging in pancreatic cancer.

But it is the Nantes-based company OSE Immunotherapeutics which has a big lead among the range of therapeutic vaccines under development around the world. She developed Tedopi, an experimental vaccine against a type of lung cancer, for which chemotherapy is the only existing treatment option to date.

And the latest results presented by the company fuel the hope of seeing the next vaccine against cancer see the light of day. OSE Immunotherapeutics has the most advanced therapeutic cancer vaccine in clinical development among the thirty in the world. She thus presented on Monday evening positive final results of phase III trials (last stage of clinical trials before potential marketing, Editor’s note) for the treatment of certain patients suffering from non-small cell lung cancer (NSCLC), a type of advanced cancer. NSCLC represents 85% to 90% of all lung cancers in Europe.

On the Paris Stock Exchange, the reaction on the stock market lives up to the hopes raised by OSE Immunotherapeutics. Its title soared by 63% to 5.94 euros, after having been reserved for an increase at the opening.

A better quality of life

The vaccine candidate developed by OSE Immunotherapeutics targets patients who have undergone two lines of treatment, i.e. after chemotherapy and immunotherapy. However, for this group of patients who suffered an initial failure in their treatment, only a new chemotherapy with serious side effects is offered to them.

Especially since the 5-year survival rate for metastatic NSCLC is 7%, according to data from the American Cancer Society. However, OSE Immunotherapeutics’ experimental vaccine reduces the risk of death compared to chemotherapy, which remains the standard treatment to this day.

OSE Immunotherapeutics’ therapeutic vaccine aims to teach the immune system to recognize and then neutralize tumor cells. Tedopi is given every three weeks, then every eight weeks for a year, then every 12 weeks.

“One year after the start of treatment, 44.1% of these patients were still alive in the group receiving the vaccine compared to only 27.5% in the chemotherapy group,” according to the results which were published Monday in the scientific journal Annals of Oncology. The study also shows that the vaccine developed by the Nantes company, as an alternative solution to chemotherapy, makes it possible to maintain a better quality of life for patients.

New indications

This vaccine is effective in patients with the HLA-A2 + phenotype. This marker is present in 45% of the population. But the patient must still respond favorably to initial immunotherapy before a relapse. Otherwise, the therapeutic vaccine developed by OSE Immunotherapeutics will have no effect…

This study certainly brings hope, but it is nevertheless incomplete. Covid-19 disrupted clinical trials, with “one study (which) did not complete its recruitment”, specified Professor Benjamin Besse, director of clinical research at the Gustave-Roussy Institute and investigator principal of the test called Atalante-1.

Only 219 patients participated in the study in nine European countries and the United States instead of the 363 planned. The study therefore does not have “all the desired power but “it allows us to understand which population has benefited from this vaccine”, added Professor Besse. A confirmatory phase III trial evaluating Tedopi is also currently in preparation, and will be launched in early 2024, specifies OSE Immunotherapeutics.

The experimental vaccine Tedopi in non-small cell lung cancer has already been authorized for early access in Spain since March. He also benefited from compassionate access to France, Italy and Spain. This type of access, at the request of doctors, allows the use of medicines without marketing authorization for a given patient in the event that these medicines meet an uncovered therapeutic need.

In addition to non-small cell lung cancer, OSE Immunotherapeutics is conducting other Phase II clinical trials (mid-stage clinical trials) evaluating Tedopi for other indications, namely pancreatic cancer and ovarian cancer. .