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EUR77m
Research: Healthcare
At the 2024 ESMO Targeted Anticancer Therapies Congress, OSE Immunotherapeutics (OSE) presented encouraging interim results from the Phase I/II dose escalation and expansion study for OSE-279, its anti-PD1 monoclonal antibody. The data show promising preliminary efficacy in patients with advanced solid tumours with no therapeutics options available. The mono therapy has also continued to demonstrate a desirable pharmacokinetic/pharmacodynamic (PK/PD) profile and manageable safety. OSE is investigating various combination approaches, such as with its lead cancer vaccine Tedopi, which we believe could maximise the potential of its proprietary therapies. OSE has six ongoing clinical studies (across several indications) and three pre-clinical assets and, in our view, the most significant upcoming milestone for the company will be initiation of the confirmatory Phase III trial for Tedopi in second-line non-small cell lung cancer (Q224 in the US and extension to European sites in H224).
Written by
OSE Immunotherapeutics |
Encouraging OSE-279 clinical update |
Clinical update |
Pharma and biotech |
27 February 2024 |
Share price performance
Business description
Analysts
OSE Immunotherapeutics is a research client of Edison Investment Research Limited |
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At the 2024 ESMO Targeted Anticancer Therapies Congress, OSE Immunotherapeutics (OSE) presented encouraging interim results from the Phase I/II dose escalation and expansion study for OSE-279, its anti-PD1 monoclonal antibody. The data show promising preliminary efficacy in patients with advanced solid tumours with no therapeutics options available. The mono therapy has also continued to demonstrate a desirable pharmacokinetic/pharmacodynamic (PK/PD) profile and manageable safety. OSE is investigating various combination approaches, such as with its lead cancer vaccine Tedopi, which we believe could maximise the potential of its proprietary therapies. OSE has six ongoing clinical studies (across several indications) and three pre-clinical assets and, in our view, the most significant upcoming milestone for the company will be initiation of the confirmatory Phase III trial for Tedopi in second-line non-small cell lung cancer (Q224 in the US and extension to European sites in H224).
Year |
Revenue |
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 |
2.7 |
(26.2) |
(1.34) |
0.0 |
N/A |
N/A |
12/24e |
15.0 |
(21.8) |
(0.98) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
The latest update corresponds to the first 20 patients, representing 13 different tumour types, from the Phase I/II trial for OSE-279 and was consistent with the positive sentiment from the previous update (October 2023). This is a first-in-human, open-label study aiming to establish the maximum tolerated dose and/or recommended Phase II dose (RP2D) of OSE-279 (monotherapy) in advanced solid tumours. Secondary objectives include antitumor activity, as well as safety, PK/PD and receptor occupancy. The results show four confirmed partial responses (PR) from patients receiving 600mg every six weeks (q6w), with a 36% response rate in patients with anal squamous cell carcinoma, undifferentiated pleomorphic sarcoma, oncocytic thyroid cancer and alveolar soft part sarcoma. One ongoing PR (81% reduction of target lesions) was also reported for a hepatocellular carcinoma patient after a single dose (300mg). Stable disease was reported in five patients (multiple dose levels) and treatment is ongoing in seven patients. Importantly, at 600mg q6w, there were no dose-limiting toxicities (n=10) and, therefore, in addition to the RP2D of 300mg every three weeks, 600mg q6w has been selected as the second RP2D. Collectively, we believe these results highlight the potential of OSE-279 in challenging-to-treat patient populations and support further clinical development. We expect an update from management as more material information becomes available.
As a reminder, OSE-279 serves as the key anti-PD1 component of OSE’s bifunctional checkpoint inhibitor (BiCKI) platform, which has been designed to address primary (lack of response to treatment) and secondary resistance (resistance after an initial response) mechanisms. In our view, incremental positive results for OSE-279 may also provide validation for the BiCKI platform approach.
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Research: Healthcare
Immix has shared a 12-month recap, capturing key clinical and regulatory events from 2023, setting the stage for an active 2024. Its lead CAR-T asset (NXC-201) is a B-cell maturation antigen (BCMA) targeting therapy for amyloid light chain amyloidosis (ALA) and multiple myeloma (MM). The latest clinical data (Phase Ib/IIa NEXICART-1 trial) showed an overall response rate (ORR) of 100% in ALA patients (n=10) and 90% in MM patients (n=50). On the regulatory front, NXC-201 received Orphan Drug designation (ODD) in February 2024 from the EMA for ALA, and in Q323 from the FDA for ALA and MM. The FDA also cleared Immix’s Investigational New Drug (IND) application in Q423, permitting NXC-201 dosing at US trial sites (NEXICART-2 trial for ALA patients). We believe this is an important development step for NXC-201, and we look forward to rolling data readouts after the start of NEXICART-2, most likely in H124.