# OSE2101

Source: https://onco.cc/drugs/ose2101/  
OnCo record `ose2101` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- 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.

## Sources

- ClinicalTrials.gov: trials of OSE2101: https://clinicaltrials.gov/search?intr=OSE2101
- Sponsor pipeline page: https://www.ose-immuno.com/en/pipeline/tedopi/

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- targets: [CEACAM5](https://onco.cc/targets/ceacam5/), [HER2](https://onco.cc/targets/her2/), [TP53](https://onco.cc/targets/tp53/)
- companies: [OSE Immunotherapeutics](https://onco.cc/companies/ose-immunotherapeutics/)
- trials: [Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas](https://onco.cc/trials/nct05751798/), [Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor](https://onco.cc/trials/nct06472245/)

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JSON: https://onco.cc/api/v1/entities/ose2101.json