Currency in EUR
Last close As at 25/03/2023
EUR5.08
▲ −0.05 (−0.97%)
Market capitalisation
EUR95m
Research: Healthcare
OSE Immunotherapeutics has highlighted recent clinical data for its multiple neoepitope cancer vaccine, Tedopi (OSE2101) at the American Society of Clinical Oncology (ASCO) Annual Meeting 2022. Final data analysis from the Phase III ATALANTE-1 trial (in patients with HLA-A2 positive non-small cell lung cancer (NSCLC) who failed immune checkpoint inhibitor (ICI) treatment) showed that Tedopi significantly improves overall survival and maintains positive patient-reported outcomes (PROs), quality of life and safety versus standard-of-care (SoC) chemotherapy (docetaxel or pemetrexed). These results build on the previously established efficacy of Tedopi in NSCLC, in our view. We expect management will now discuss the results with regulators to enter the early access programme for potential filling at year-end 2022 in NSCLC.
OSE Immunotherapeutics |
Tedopi clinical data in NSCLC and PDAC |
Clinical data update |
Pharma and biotech |
8 June 2022 |
Share price performance Business description
Analysts
OSE Immunotherapeutics is a research client of Edison Investment Research Limited |
OSE Immunotherapeutics has highlighted recent clinical data for its multiple neoepitope cancer vaccine, Tedopi (OSE2101) at the American Society of Clinical Oncology (ASCO) Annual Meeting 2022. Final data analysis from the Phase III ATALANTE-1 trial (in patients with HLA-A2 positive non-small cell lung cancer (NSCLC) who failed immune checkpoint inhibitor (ICI) treatment) showed that Tedopi significantly improves overall survival and maintains positive patient-reported outcomes (PROs), quality of life and safety versus standard-of-care (SoC) chemotherapy (docetaxel or pemetrexed). These results build on the previously established efficacy of Tedopi in NSCLC, in our view. We expect management will now discuss the results with regulators to enter the early access programme for potential filling at year-end 2022 in NSCLC.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
DPS |
Yield |
12/20 |
10.4 |
(18.5) |
(1.02) |
0.0 |
N/A |
N/A |
12/21 |
26.3 |
(16.5) |
(0.89) |
0.0 |
N/A |
N/A |
12/22e |
5.0 |
(38.8) |
(1.89) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(44.2) |
(2.42) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
The Phase III ATALANTE-1 trial (NCT02654587) is a randomised trial investigating Tedopi in the second- or third-line treatment of metastatic or advanced HLA-A2 positive NSCLC patients with progressive disease after treatment with ICIs versus SoC. An extensive post hoc analysis and final results were presented at the European Society for Medical Oncology (ESMO) Congress in September 2021, after the trial was disrupted by COVID-19. The PRO data presented at ASCO 2022 indicate that patients maintain quality of life when treated with Tedopi and have longer median time to worsening of ECOG performance status (5.3 months longer compared to SoC).
Additionally, management highlighted interim data from the Phase II TEDOPaM study (sponsored by GERCOR, NCT03806309) of Tedopi as a maintenance therapy (monotherapy or in combination with Opdivo) in pancreatic ductal adenocarcinoma (PDAC) patients (n=29) with or after FOLFIRI treatment. After review by an independent data monitoring committee, the study is ongoing with a new design (maintenance FOLFIRI + Tedopi). On the committee’s recommendation, arm C of the study was discontinued after analysis showed that the Opdivo + Tedopi combination was associated with poorer patient outcomes (30% one-year overall survival versus 44% for SoC). Two Opdivo-related deaths were recorded in this arm. Maintenance therapy with Tedopi alone showed a favourable safety profile.
|
|
Research: Investment Companies
Axiom European Financial Debt Fund (AXI) is a closed-end fund that invests in European financials regulatory capital. If a bank’s operations and equity position are robust enough to withstand shock asset losses, these instruments can provide a way to earn a premium return. Despite volatile and declining markets, AXI had a total return of 6% in the last 12 months, outperforming the ICE BofA euro financial and European high yield indices. The deteriorating macroeconomic outlook means higher loan impairments are likely, but we feel this is mostly an equity story and that, for the majority of banks, the regulatory capital instruments in which AXI invests will not be called on to absorb asset losses, allowing AXI to benefit from their premium yields. The portfolio has an 8.4% running yield, 9.7% to perpetuity. AXI is trading on a 9% net asset value (NAV) discount with a 6.7% dividend.
Get access to the very latest content matched to your personal investment style.