Whilst OSE has not yet released full results from the trial, the company has said that the trial met its OS goal showing positive outcomes. Credit: Shutterstock / Jo Panuwat D.
OSE Immunotherapeutics’s Phase II trial examining its neoepitope-based therapeutic cancer vaccine Tedopi (OSE2101) in patients with pancreatic ductal adenocarcinoma (PDAC) has impacted one-year overall survival (OS).
The French company’s randomised, non-comparative TEDOPaM study (NCT03806309) examined the efficacy of the company’s potential cancer vaccine in combination with Opdivo (nivolumab) followed by chemotherapy compound treatment FOLFIRI, against FOLFIRI as maintenance therapy.
Whilst the company has not yet released full results from the trial, the company has said that the trial met its OS goal showing positive outcomes according to a predefined statistical hypothesis with minimal toxicity from Tedopi.
The company’s stock, listed on the Euronext Paris (EPA) exchange, saw a 19% at market open this morning (12 March) from a €5.79 ($6.31) close on 11 March to a €6.90 ($7.53) open.
Cindy Neuzillet, principal investigator of the TEDOPaM study, said: “These are positive results in a non-comparative trial. That said, we need to better understand the contribution of Tedopi in the context of this combination. A large translational program on tumour tissue, blood, and imaging is ongoing.
“Additional analysis at a longer time point will also be necessary for more mature survival data. These results underscore the critical need for ongoing research and the development of more effective therapies, especially given the low long-term survival rates in pancreatic cancer. Every step we take brings us closer to making a meaningful impact in the fight against this challenging disease.”
The multi-centre trial recruited up to 107 patients at sites across France living with HLA-A2 positive PDAC, meaning an individual’s cells express the HLA-A2 protein that prompts an immune system response, who had seen no progression after eight cycles of FOLFIRINOX induction chemotherapy.
PDAC is an aggressive form of cancer that originates in a patient’s pancreatic ducts. Research by the American Cancer Society estimates that in 2025 alone 34,950 men and 32,490 women will be diagnosed with pancreatic cancer. Additionally, 51,980 people will die from the disease. The average lifetime risk of pancreatic cancer is about one in 56 in men and about one in 60 in women.
GlobalData’s Pharmaceutical Intelligence Center estimates that should Tedopi make it to market, the potential cancer vaccine could bring in $95m in 2029, with that figure set to rise to $334m by the end of 2031.
GlobalData is the parent company of Clinical Trials Arena.
OSE Immunotherapeutics CEO Nicolas Poirier said: “The initial results provide a glimmer of hope in the fight against advanced or metastatic pancreatic cancer. This disease is notoriously difficult to treat, and the need for effective therapies is urgent. These early results show potential promising benefit in some subsets of patients; further research and analysis are needed to confirm their impact.”
Elsewhere in the world of pancreatic cancer, BullFrog AI Holdings announced a partnership agreement last month with Eleison Pharmaceuticals to apply its AI solutions to Eleison’s pivotal Phase III trial of its pancreatic cancer treatment, glufosfamide. Meanwhile, Candel Therapeutics’ Phase II trial has seen its immunotherapy candidate elicit a median OS of 31.4 months in patients with non-metastatic PDAC.
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