OSE Immunotherapeutics (OSE) has announced a new three-year strategic plan to accelerate late-stage programs while maintaining financial discipline.
The company confirmed progress in its pivotal Phase 3 ARTEMIA trial of Tedopi for non-small cell lung cancer (NSCLC), with a futility analysis expected in Q3 2026 and full read-out in Q1 2028.
Tedopi, a cancer vaccine targeting tumor neoantigens, is also supported by ongoing investigator-led Phase 2 studies that may provide additional proof-of-concept data at limited cost.
A central focus of the plan is Lusvertikimab currently in Phase 2, OSE's monoclonal antibody targeting the IL-7R, a pathway involved in immune-mediated diseases. The company will advance the intravenous (IV) formulation into one or two rare or specialty indications with high unmet need, using a precision medicine approach. These indications will be disclosed in early 2026.
In addition, OSE is pivoting the ulcerative colitis (UC) program to a subcutaneous (SC) formulation to align with market demand for more convenient delivery.
The IV formulation of Lusvertikimab has already shown promising results in Phase 2 CoTikiS study of Lusvertikimab IV in UC. Data from this trial identified a biomarker that appears predictive of strong clinical response in approximately 25% of patients. Biomarker data suggest up to 30% of patients could achieve remission, positioning Lusvertikimab SC as a potential breakthrough in UC.
The company also emphasized its commitment to maintaining scientific leadership by exploring combination strategies and advancing preclinical assets at limited cost.
OSE enters this strategic cycle with financial visibility until early Q4 2026, supported by potential milestone payments, including EUR 17.5 million from Boehringer Ingelheim related to the 2024 acquisition of a cis-targeting anti-PD- 1/cytokine asset.
CEO Marc Le Bozec said that the strategy focuses resources on programs with the greatest near-term catalysts while preparing assets for partnerships once Phase 3-ready.
On the Frankfurt exchange, OSE shares are currently at 4.73 euros, down 2.87 percent.
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