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EUR77m
Research: Healthcare
OSE has announced that it has received positive recommendations from its ‘type C’ meeting with the FDA for the planned confirmatory Phase III trial design for Tedopi (neoepitope cancer vaccine), as a second-line treatment in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure. This follows similar advice from the European Medicines Agency (EMA). The company will now undertake the pivotal trial as monotherapy (against standard of care) under this protocol, for patients with HLA-A2+ tumours (c 45% of total population). As a reminder, OSE reported positive data from the previous Phase III ATALANTE-1 trial as second/third-line treatment, although enrolment had to be terminated prematurely due to the COVID-19 pandemic.
Written by
OSE Immunotherapeutics |
FDA support received for Tedopi Phase III trial |
Regulatory update |
Pharma and biotech |
16 February 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 it has received positive recommendations from its ‘type C’ meeting with the FDA for the planned confirmatory Phase III trial design for Tedopi (neoepitope cancer vaccine), as a second-line treatment in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure. This follows similar advice from the European Medicines Agency (EMA). The company will now undertake the pivotal trial as monotherapy (against standard of care) under this protocol, for patients with HLA-A2+ tumours (c 45% of total population). As a reminder, OSE reported positive data from the previous Phase III ATALANTE-1 trial as second/third-line treatment, although enrolment had to be terminated prematurely due to the COVID-19 pandemic.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
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 |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Following endorsement by the FDA and EMA on the proposed trial design, OSE will work on protocol development for the new Phase III trial, which should support the regulatory registration of Tedopi. The confirmatory trial is aimed at HLA-A2+ patients with secondary resistance to immunotherapy (IO)/checkpoint inhibitors after a first line of chemo-IO, followed by failure to maintain IO of at least 12 weeks (the threshold for secondary/acquired resistance). This new development comes after positive data were reported from the truncated Phase III ATALANTE-1 trial in H122, which demonstrated a 44.4% one-year overall survival rate versus 27.5% with chemotherapy along with a superior safety profile.
The Phase III ATALANTE-1 trial evaluated Tedopi as second- or third-line treatment following checkpoint inhibitor failure in HLA-A2+ patients (with locally advanced (stage IIIB), or metastatic (stage IV) NSCLC. The comparator to Tedopi treatment was docetaxel or pemetrexed chemotherapy. Overall survival was the primary endpoint of the trial. Patients who have failed immune checkpoint inhibitor treatment represent an unmet space where no novel treatment has been approved yet, presenting a sizeable market opportunity.
In addition to the above, OSE has three ongoing Phase II trials for Tedopi, led by clinical oncology groups, aiming to expand the clinical utility of Tedopi in combination with Opdivo (NSCLC), Keytruda (ovarian cancer) and chemotherapy (pancreatic cancer). If Tedopi can demonstrate similar or increased survival as a combination regimen compared to the monotherapy in these indications, we expect it could significantly increase the commercial impact of the neoepitope cancer vaccine.
Tedopi is currently available through compassionate use programmes in third or further lines of treatment (post chemotherapy and immunotherapy) in France, Italy and Spain.
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Research: TMT
Checkit’s FY23 trading update confirmed that year-end annual recurring revenue (ARR), FY23 reported revenue and year-end net cash beat our forecasts. ARR increased 28% y-o-y despite the challenging economic environment, as the company made good progress signing up new customers and expanding existing contracts. With 93% recurring revenue for continuing operations, the transition to a subscription-based model is complete. We will review our forecasts following FY23 results on 27 April.