{"entity":{"id":"bt-001","kind":"drug","name":"BT-001","aka":[],"tldr":"BT-001 is an experimental oncolytic virus encoding an anti-CTLA-4 antibody and GM-CSF from BioInvent International, in phase 2 trials for metastatic solid tumours, melanoma and soft tissue sarcoma and other cancers; its current status is not stated.","summary":"BT-001 is an oncolytic virus (vaccinia) encoding an anti-CTLA-4 antibody and GM-CSF from BioInvent International, with Transgene as partner. An oncolytic virus built on Transgene's Invir.IO platform that encodes a Treg-depleting anti-CTLA-4 antibody from BioInvent and human GM-CSF, releasing the antibody locally in the tumour. Its furthest stage is phase 2, for metastatic solid tumours, melanoma, soft tissue sarcoma and merkel cell carcinoma. ClinicalTrials.gov registers it in one study linked below. Registry record NCT04725331 (lead sponsor Transgene, BioInvent and MSD collaborators) shows TERMINATED, while BioInvent's programme page still says 'Clinical phase 1/2a study (NCT04725331) ongoing'. Conflict; do not call it active. Whether it works in people has not been established unless a trial below reports it.","status":"phase-2","asOf":"2026-11-03","links":[{"label":"BioInvent International: bioinvent.com","url":"https://www.bioinvent.com/en/clinical-programs/our-programs/bt-001ctla-4gm-csf"},{"label":"BioInvent International: clinicaltrials.gov","url":"https://clinicaltrials.gov/api/v2/studies/NCT04725331"},{"label":"ClinicalTrials.gov: trials of BT-001","url":"https://clinicaltrials.gov/search?intr=BT-001"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","melanoma","sarcoma","merkel-cell-carcinoma","tnbc","nsclc"],"sections":[],"technologies":[],"targets":["ctla4"],"drugs":[],"companies":["bioinvent-international","transgene"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04725331"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"code":"BT-001","modality":"Oncolytic virus (vaccinia) encoding an anti-CTLA-4 antibody and GM-CSF","mechanism":"An oncolytic virus built on Transgene's Invir.IO platform that encodes a Treg-depleting anti-CTLA-4 antibody from BioInvent and human GM-CSF, releasing the antibody locally in the tumour.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/bt-001/","neighbours":{"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"merkel-cell-carcinoma","kind":"cancer","name":"Merkel cell carcinoma","route":"/cancers/merkel-cell-carcinoma/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"ctla4","kind":"target","name":"CTLA-4","route":"/targets/ctla4/"}],"company":[{"id":"bioinvent-international","kind":"company","name":"BioInvent International","route":"/companies/bioinvent-international/"},{"id":"transgene","kind":"company","name":"Transgene","route":"/companies/transgene/"}],"trial":[{"id":"nct04725331","kind":"trial","name":"A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors","route":"/trials/nct04725331/"}]}}