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OSE2101
OSE2101 is a therapeutic cancer vaccine that targets WT1 (Wilms tumor antigen 1) to activate the immune system against WT1-expressing tumor cells.
OSE2101 is a therapeutic cancer vaccine that targets WT1 (Wilms tumor antigen 1) to activate the immune system against WT1-expressing tumor cells. Used for Acute myeloid leukemia (AML) in combination with chemotherapy, Ovarian cancer (in development).
At a glance
| Generic name | OSE2101 |
|---|---|
| Also known as | Tedopi, TEDOPI, EP-2101, EP2101, IDM-2101 |
| Sponsor | GERCOR - Multidisciplinary Oncology Cooperative Group |
| Drug class | Therapeutic cancer vaccine |
| Target | WT1 (Wilms tumor antigen 1) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
OSE2101 is a dendritic cell-based immunotherapy designed to stimulate CD8+ T-cell responses against WT1, a tumor-associated antigen frequently overexpressed in various cancers. By priming the immune system to recognize and attack WT1-positive cancer cells, the vaccine aims to provide durable anti-tumor immunity. It is typically used in combination with chemotherapy or other immunotherapies to enhance overall treatment efficacy.
Approved indications
- Acute myeloid leukemia (AML) in combination with chemotherapy
- Ovarian cancer (in development)
Common side effects
- Injection site reactions
- Fever
- Fatigue
- Flu-like symptoms
Key clinical trials
- Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor (PHASE3)
- Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas (PHASE1, PHASE2)
- A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study. (PHASE2)
- OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC (PHASE2)
- OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC (PHASE2)
- OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- OSE2101 CI brief — competitive landscape report
- OSE2101 updates RSS · CI watch RSS
- GERCOR - Multidisciplinary Oncology Cooperative Group portfolio CI