{"id":"ose2101","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Flu-like symptoms"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"OSE2101 is a therapeutic cancer vaccine that targets WT1 (Wilms tumor antigen 1) to activate the immune system against WT1-expressing tumor cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:24:55.171Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute myeloid leukemia (AML) in combination with chemotherapy"},{"name":"Ovarian cancer (in development)"}]},"trialDetails":[{"nctId":"NCT06472245","phase":"PHASE3","title":"Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor","status":"RECRUITING","sponsor":"OSE Immunotherapeutics","startDate":"2024-12-03","conditions":"Patients With Non-Small Cell Lung Cancer","enrollment":363},{"nctId":"NCT05751798","phase":"PHASE1, PHASE2","title":"Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas","status":"RECRUITING","sponsor":"OSE Immunotherapeutics","startDate":"2022-12-20","conditions":"Solid Advanced Tumor, Lymphoma, NSCLC (Non-small Cell Lung Cancer)","enrollment":41},{"nctId":"NCT07264673","phase":"PHASE2","title":"A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.","status":"RECRUITING","sponsor":"Fondazione Ricerca Traslazionale","startDate":"2025-04-17","conditions":"NSCLC","enrollment":160},{"nctId":"NCT03806309","phase":"PHASE2","title":"OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC","status":"ACTIVE_NOT_RECRUITING","sponsor":"GERCOR - Multidisciplinary Oncology Cooperative Group","startDate":"2021-04-10","conditions":"Pancreatic Ductal Adenocarcinoma, Locally Advanced Cancer, Metastatic Cancer","enrollment":106},{"nctId":"NCT04713514","phase":"PHASE2","title":"OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC","status":"ACTIVE_NOT_RECRUITING","sponsor":"ARCAGY/ GINECO GROUP","startDate":"2021-08-05","conditions":"Platinum-sensitive Ovarian Cancer, Relapsed Ovarian Cancer","enrollment":180},{"nctId":"NCT02654587","phase":"PHASE3","title":"OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure","status":"TERMINATED","sponsor":"OSE Immunotherapeutics","startDate":"2016-02-12","conditions":"Non Small Cell Lung Cancer","enrollment":219}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Tedopi","TEDOPI","EP-2101","EP2101","IDM-2101"],"phase":"phase_3","status":"active","brandName":"OSE2101","genericName":"OSE2101","companyName":"GERCOR - Multidisciplinary Oncology Cooperative Group","companyId":"gercor-multidisciplinary-oncology-cooperative-group","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}