OSE Immunotherapeutics is the French biotech company that established — through a landmark Phase 3 trial result — that therapeutic cancer vaccines can extend patient survival in one of oncology’s most difficult indications. Its Tedopi vaccine for non-small cell lung cancer (NSCLC) showed 46% two-year overall survival in HLA-A2-positive patients, a result that triggered a cascade of France 2030-supported investments and positioned the Nantes-based company as a national champion in immuno-oncology.

The Company and Its Pipeline

Founded in 2012 through the merger of Proteome Sciences’ French subsidiary and OSE Pharma, OSE Immunotherapeutics is headquartered at the Institut de Recherche en Santé of the University of Nantes. The Nantes location is not coincidental — the university’s immunology department, led by Professor Régis Josien, is one of France’s leading academic centers for transplant immunology and tumor immunology, providing the scientific foundation for OSE’s pipeline.

The company is publicly listed on Euronext Paris (ticker: OSE) with a market capitalization that has ranged between €100 million and €200 million since 2020. It employs approximately 50 people, making it a lean, research-focused organization typical of the mid-stage European biotech model.

Core Pipeline:

Tedopi (OSE-2101) — Lung Cancer Therapeutic Vaccine Tedopi is a neoepitope-based vaccine targeting five tumor antigens (MAGE-A1, MAGE-A3, CEA, HER-2/neu, p53) expressed on NSCLC tumor cells. It is formulated with the ISA 51 VG adjuvant and administered to HLA-A2-positive patients (approximately 50% of the Caucasian population). The pivotal Phase 3 Atalante-1 trial enrolled 219 patients with HLA-A2-positive stage III/IV NSCLC who had stabilized after immune checkpoint inhibitor therapy.

The Atalante-1 result — 46.0% two-year overall survival for Tedopi versus 32.2% for standard chemotherapy — represented a statistically significant and clinically meaningful survival benefit (p=0.037). OSE submitted a marketing authorization application to the EMA in Q1 2025, with approval decision expected in 2026. If approved, Tedopi would be the first therapeutic cancer vaccine approved for NSCLC globally.

Lusvertikimab (FR104/OSE-127) — Autoimmune Diseases Lusvertikimab is an anti-IL-7 receptor alpha antibody targeting the interleukin-7 signaling pathway, which drives autoimmune tissue destruction in conditions including ulcerative colitis, Sjögren’s syndrome, and organ transplant rejection. The Phase 2a results in ulcerative colitis (2023) showed 37% clinical response rate, supporting advancement to Phase 2b.

Lusvertikimab was co-developed with Servier under a collaboration agreement signed in 2019. Servier holds the commercialization rights for the autoimmune indications, providing OSE with development funding and milestone payments. The total potential value of the Servier collaboration is €150 million in milestones plus royalties.

BI 765063/OSE-172 — Cancer (Partnered with Boehringer Ingelheim) OSE’s anti-SIRPα antibody, designed to remove a key inhibitory checkpoint on macrophages in the tumor microenvironment, is being developed in collaboration with Boehringer Ingelheim. Phase 1 data showed favorable safety and early signs of immune activation. Boehringer Ingelheim assumed full funding in 2022, providing OSE with milestone-based economics.

France 2030 Support: i-Bio and INSERM Grants

OSE Immunotherapeutics received €12 million from Bpifrance’s i-Bio competition in 2022 — one of the largest single i-Bio awards to a clinical-stage oncology company. The grant was specifically earmarked for:

1. Tedopi manufacturing scale-up: Funding the GMP manufacturing campaign for commercial-scale Tedopi drug substance at OSE’s contract manufacturer (Lonza, Switzerland), ensuring supply chain readiness ahead of potential EMA approval
2. Phase 3 extension studies: Additional clinical studies of Tedopi in earlier-stage NSCLC and in combination with checkpoint inhibitors
3. Neoepitope platform expansion: Research into the next generation of Tedopi-type vaccines targeting solid tumors beyond lung cancer (colorectal, bladder)

In addition, OSE has received multiple INSERM collaborative grants totaling approximately €8 million for academic research partnerships, including a joint research program with the University Hospital of Nantes on transplant tolerance (using Lusvertikimab in kidney transplant rejection prevention).

The Nantes Health Innovation Cluster

OSE Immunotherapeutics is one of the anchor tenants of the Nantes health innovation ecosystem, alongside Obepine (wastewater epidemiology), OSE’s spin-out Abivax (antiviral), and a cluster of University Hospital-linked biotechs. Nantes Université and the CHU de Nantes are both France 2030 beneficiaries through the Excellence in Research initiative, which has directed approximately €45 million to cancer immunology and transplant medicine research in the region.

The geographic concentration matters: proximity to the University Hospital gives OSE direct access to clinical trial patients and principal investigators for its oncology and transplant programs — a significant competitive advantage over Paris-based biotechs that must compete for CHU resources in a more crowded environment.

Commercial Prospects and Investment Thesis

Tedopi’s EMA submission represents the most significant near-term value inflection point for OSE. The market opportunity: approximately 500,000 new NSCLC patients are diagnosed annually in Europe, of whom roughly 250,000 are HLA-A2-positive. If Tedopi is approved and achieves even 10% market penetration at a premium therapeutic cancer vaccine price point (estimated €40,000-60,000 per treatment course), the European market alone represents €1-1.5 billion in peak annual revenues — approximately 8-10x OSE’s current enterprise value.

The critical variable for investors: EMA’s assessment of the Atalante-1 trial design. The trial enrolled a relatively small patient population (219 patients) and the patient selection criterion (HLA-A2 positivity) requires companion diagnostics — a commercialization complexity that could slow market uptake even if approval is granted.

For France 2030, OSE represents the model for medium-sized, clinically differentiated biotechs: not a unicorn startup, not a pharma giant, but a company that converts sustained public and private investment into genuine therapeutic innovation. The potential first approval of a cancer therapeutic vaccine in Europe would be a landmark event for French biotech’s global reputation.

Related: France 2030 Health Sector Hub | i-Bio Funding Program | Clinical Trials in France | DNA Script