{"entity":{"id":"ose2101","kind":"drug","name":"OSE2101","aka":[],"tldr":"OSE2101 is an experimental cancer vaccine from OSE Immunotherapeutics in phase 3 trials for non-small-cell lung cancer, aimed at HER2 and CEACAM5.","summary":"OSE2101 is a cancer vaccine developed by OSE Immunotherapeutics. Its targets are HER2, CEACAM5 and TP53 (the sponsor names P53, HER-2, CEA, MAGE-2, MAGE-3 (HLA-A2-restricted epitopes) plus PADRE pan-HLA-DR epitope). The sponsor states: A peptide vaccine composed of nine HLA-A2-restricted tumour-associated antigen epitopes plus one pan-HLA-DR binding epitope, emulsified in Montanide ISA 51 adjuvant, that activates tumour-specific T lymphocytes. ClinicalTrials.gov describes the intervention as: OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2 phenotype targeting the tumour associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3, and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT06472245 (Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor), in non-small-cell lung cancer. The largest, NCT06472245, plans to enrol 363 participants with primary completion expected 2027-12-15. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of OSE2101","url":"https://clinicaltrials.gov/search?intr=OSE2101"},{"label":"Sponsor pipeline page","url":"https://www.ose-immuno.com/en/pipeline/tedopi/"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":["her2","ceacam5","tp53"],"drugs":[],"companies":["ose-immunotherapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06472245","nct05751798"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"vaccine","mechanism":"A peptide vaccine composed of nine HLA-A2-restricted tumour-associated antigen epitopes plus one pan-HLA-DR binding epitope, emulsified in Montanide ISA 51 adjuvant, that activates tumour-specific T lymphocytes.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ose2101/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"target":[{"id":"ceacam5","kind":"target","name":"CEACAM5","route":"/targets/ceacam5/"},{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"},{"id":"tp53","kind":"target","name":"TP53","route":"/targets/tp53/"}],"company":[{"id":"ose-immunotherapeutics","kind":"company","name":"OSE Immunotherapeutics","route":"/companies/ose-immunotherapeutics/"}],"trial":[{"id":"nct05751798","kind":"trial","name":"Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas","route":"/trials/nct05751798/"},{"id":"nct06472245","kind":"trial","name":"Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor","route":"/trials/nct06472245/"}]}}