OSE Immunotherapeutics — Tedopi shows promise in pancreatic cancer

OSE Immunotherapeutics (PAR: OSE)

Last close As at 11/03/2025

EUR5.79

−0.46 (−7.36%)

Market capitalisation

EUR128m

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Research: Healthcare

OSE Immunotherapeutics — Tedopi shows promise in pancreatic cancer

OSE Immunotherapeutics has reported positive top-line data from the investigator-sponsored Phase II trial assessing Tedopi in combination with FOLFIRI (a three-drug chemotherapy regimen made up of folinic acid, fluorouracil and irinotecan) in patients with pancreatic cancer (advanced or metastatic pancreatic ductal adenocarcinoma, PDAC). Importantly, the trial met the primary endpoint of one-year overall survival and demonstrated favourable safety outcomes, laying a robust foundation for further development efforts, in our view. Follow-up and translational analyses are ongoing, and management plans to communicate more detailed results at conferences in the coming months. We remind readers that the lead Tedopi programme is focused on non-small cell lung cancer (NSCLC); the registrational Phase III ARTEMIA trial is ongoing and due to conclude in 2027.

Jyoti Prakash

Written by

Jyoti Prakash, CFA

Director, healthcare

Healthcare

Clinical update

12 March 2025

Price €5.93
Market cap €130m

€0.92/US$

Net cash/(debt)

€80.8m

Shares in issue

21.9m
Free float 65.0%
Code OSE
Primary exchange NXT PA
Secondary exchange N/A
Price Performance

Business description

OSE Immunotherapeutics (OSE) is based in Nantes and Paris in France and is listed on the Euronext Paris exchange. It is developing immunotherapies for the treatment of solid tumours and autoimmune diseases and has established several partnerships with large pharma companies.

Analysts

Jyoti Prakash, CFA
+44 (0)20 3077 5700
Arron Aatkar, PhD
+44 (0)20 3077 5700

OSE Immunotherapeutics is a research client of Edison Investment Research Limited

Note: PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Year end Revenue (€m) PBT (€m) EPS (€) DPS (€) P/E (x) Yield (%)
12/22 18.3 (18.0) (0.96) 0.00 N/A N/A
12/23 2.2 (23.2) (1.18) 0.00 N/A N/A
12/24e 98.5 64.5 2.80 0.00 2.1 N/A
12/25e 86.3 50.9 2.33 0.00 2.5 N/A

According to the announcement, positive top-line results have been reported for OSE’s lead off-the-shelf neoepitope-based cancer vaccine, Tedopi, in PDAC, as part of the non-comparative combination trial (n=107) sponsored and conducted by the French oncology group, GERCOR. The Phase II trial was designed to evaluate Tedopi in combination with FOLFIRI as a maintenance treatment approach in HLA-A2 positive PDAC patients showing no progression following eight cycles of FOLFIRINOX induction chemotherapy (a four-drug chemotherapy regimen comprising FOLFIRI plus oxaliplatin). Given that Tedopi is an HLA-A2-targeted treatment, we believe encouragement should be taken from these results, offering the potential to expand the clinical utility of Tedopi beyond the lead indication of NSCLC, especially as PDAC is a particularly challenging indication to treat with limited effective therapies available at present.

As a reminder, OSE’s strategic priority is the registrational Phase III ARTEMIA trial. ARTEMIA is assessing Tedopi in HLA-A2 positive NSCLC patients as a monotherapy in the second-line setting. Participants (expected n=363) are randomised 2:1 to receive either Tedopi or standard-of-care docetaxel treatment. The programme is supported by a companion diagnostic screening test to identify HLA-A2 positive patients. Interim updates are expected from 2026, followed by top-line results in 2027.

We believe that OSE’s strategy to explore Tedopi in additional oncology indications is sensible, offering the potential to maximise the clinical utility of the cancer vaccine, should the data be supportive, though we recognise that investigator-sponsored trials may not necessarily align with OSE’s future clinical development strategy for the candidate. OSE had engaged in three Phase II trials assessing Tedopi in various oncology indications and through various combination approaches. The PDAC trial was the first to report top-line results. The remaining two trials are in ovarian cancer, in combination with pembrolizumab (top-line results expected from Q226) and in NSCLC, in combination with nivolumab (top-line results expected from H226).

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