OSE Immunotherapeutics' Cancer Vaccine Shows Promise in Phase 2 Pancreatic Cancer Trial

OSE Immunotherapeutics, a French biotech company, has unveiled encouraging results from a phase 2 clinical trial of its therapeutic cancer vaccine, Tedopi, in patients with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). The data, presented at the American Society of Clinical Oncology (ASCO) meeting, highlights the potential of this novel treatment approach in a notoriously difficult-to-treat cancer type.

Tedopi's Phase 2 Success

The phase 2 study evaluated Tedopi in combination with chemotherapy against chemotherapy alone in 107 PDAC patients who had not progressed after eight cycles of FOLFIRINOX induction chemotherapy. The trial met its primary endpoint of overall survival, with the Tedopi arm demonstrating a 12-month overall survival rate of 65% among the 54 patients who received the combination treatment.

Dr. Cindy Neuzillet, the study's principal investigator, described the results as "an encouraging first step towards better understanding the contribution of Tedopi in combination therapy in advanced pancreatic cancer." However, she emphasized the need for more mature data on overall survival over a longer period.

Safety Profile and Efficacy Indicators

The safety profile of Tedopi appeared manageable, with 26% of patients in the Tedopi arm reporting serious adverse events, of which 6% were deemed related to the vaccine. Importantly, no new safety signals were reported during the trial.

In terms of efficacy, the Tedopi arm saw two complete responses, compared to none in the chemotherapy-only group. The median follow-up time for the trial was 21 months, with approximately 35% of patients succumbing to the disease during the study period.

Tedopi: A "Pipeline in a Product"

Tedopi's unique design combines 10 neo-epitopes derived from five tumor antigens, selected for their presence across various tumor types. This multi-target approach positions Tedopi as a potential "pipeline in a product" for HLA-A2 positive patients, according to Dr. Silvia Comis, Chief Clinical and Medical Research Officer at OSE.

The company is currently conducting five clinical trials of Tedopi in various oncology indications, including a phase 3 study in non-small cell lung cancer (NSCLC). Additional phase 2 readouts in NSCLC and ovarian cancer are expected next year, potentially expanding the therapeutic scope of this promising cancer vaccine.