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EUR77m
Research: Healthcare
OSE has announced that the results from its Phase III trial (ATALANTE-1) for Tedopi have been published in Annals of Oncology. While the study results were first presented in September 2021, the company’s share price rose sharply following the publication announcement, highlighting significant interest in the company’s lead cancer vaccine. The results from this trial were encouraging, showing a 41% reduction in the risk of death in the Tedopi arm versus standard of care (SoC) chemotherapy. After discussions with regulators (FDA and EMA), OSE is preparing for a follow-on confirmatory pivotal Phase III trial, which we expect to commence in early 2024.
Written by
OSE Immunotherapeutics |
Publication puts Tedopi back in the spotlight |
Company update |
Pharma and biotech |
14 September 2023 |
Share price performance
Business description
Analysts
OSE Immunotherapeutics is a research client of Edison Investment Research Limited |
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OSE has announced that the results from its Phase III trial (ATALANTE-1) for Tedopi have been published in Annals of Oncology. While the study results were first presented in September 2021, the company’s share price rose sharply following the publication announcement, highlighting significant interest in the company’s lead cancer vaccine. The results from this trial were encouraging, showing a 41% reduction in the risk of death in the Tedopi arm versus standard of care (SoC) chemotherapy. After discussions with regulators (FDA and EMA), OSE is preparing for a follow-on confirmatory pivotal Phase III trial, which we expect to commence in early 2024.
Year |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
26.3 |
(17.2) |
(0.95) |
0.0 |
N/A |
N/A |
12/22 |
18.3 |
(18.0) |
(0.97) |
0.0 |
N/A |
N/A |
12/23e |
15.0 |
(17.8) |
(0.96) |
0.0 |
N/A |
N/A |
12/24e |
15.0 |
(21.9) |
(1.18) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Tedopi is an off-the-shelf neoepitope cancer vaccine. ATALANTE-1 was designed to assess Tedopi as a second- or third-line treatment following immune checkpoint inhibitor (ICI) failure in patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer (NSCLC) who are HLA-A2 positive (c 45% of the NSCLC patient population). The COVID-19 pandemic had an impact on the study, with only 219 out of the planned 363 patients enrolled; this may have been a reason why results from this trial alone were insufficient for regulatory approval. However, the results were encouraging, and OSE received positive recommendations from the FDA and EMA for its planned follow-on Phase III trial.
In September 2023, OSE announced the publication of the ATALANTE-1 results in Annals of Oncology, a high-impact medical journey, re-highlighting the positive outcomes from the trial. The 219 patients enrolled in the study were randomised to receive either Tedopi (n=139) or SoC (docetaxel or pemetrexed, n=80). Of these, 118 (54%) met the definition of population of interest (secondary resistance, ie progression after 12 weeks of ICI treatment). It was found that Tedopi exhibited a desirable benefit/risk profile compared to the SoC in this secondary resistance subgroup. The primary endpoint of overall survival was achieved with statistical significance, with the risk of death reduced by 41% in the Tedopi arm. Median overall survival was 11.1 months with Tedopi versus 7.5 months with SoC. This translated to a longer median post-progression survival of 7.7 months with Tedopi versus 4.6 months with SoC. The results also demonstrated a better quality of life with the Tedopi arm, alongside a desirable tolerability profile with fewer severe adverse events (11% with Tedopi vs 35% with SoC).
The upcoming confirmatory pivotal Phase III trial assessing Tedopi as a second-line monotherapy in advanced or metastatic NSCLC is on track to commence in early 2024. We believe this trial will build on the ATALANTE-1 results by acquiring more data in a larger NSCLC patient population (expected n=400), but also with the focus being on Tedopi as a second-line monotherapy as opposed to a second- or third-line treatment. Results of this trial are expected in 2025–26.
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