{"entity":{"id":"amx-818","kind":"drug","name":"VIR-5818","aka":["AMX-818","SAR446309"],"tldr":"VIR-5818 is an experimental masked T-cell engager from Amunix Pharmaceuticals, in phase 1 trials for HER2-expressing locally advanced or metastatic solid tumours.","summary":"VIR-5818 (AMX-818, SAR446309) is a masked T-cell engager (PRO-XTEN dual-masked TCE) from Amunix Pharmaceuticals, with Sanofi as acquirer, Vir Biotechnology as licensee and Merck Sharp & Dohme as partner. A HER2-targeted T-cell engager with PRO-XTEN masks that are removed by proteases in tumours. Its furthest stage is phase 1, for HER2-expressing locally advanced or metastatic solid tumours. ClinicalTrials.gov registers it in one study linked below. Phase 1/2 NCT05356741 recruiting under Vir; updated dose-escalation data expected 2H 2026 (Vir Q2 2026 release). Whether it works in people has not been established unless a trial below reports it.","status":"phase-1","asOf":"2026-11-03","links":[{"label":"Amunix Pharmaceuticals: clinicaltrials.gov","url":"https://clinicaltrials.gov/api/v2/studies/NCT05356741"},{"label":"Amunix Pharmaceuticals: sec.gov","url":"https://www.sec.gov/Archives/edgar/data/1706431/000162828024039948/vir-20240906.htm"},{"label":"Amunix Pharmaceuticals: sec.gov","url":"https://www.sec.gov/Archives/edgar/data/1706431/000162828026053351/a20260805-q2ex991earningsr.htm"},{"label":"ClinicalTrials.gov: trials of AMX-818","url":"https://clinicaltrials.gov/search?intr=AMX-818"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":["amunix-pharmaceuticals","sanofi","merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05356741"],"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":"AMX-818","modality":"Masked T-cell engager (PRO-XTEN dual-masked TCE)","mechanism":"A HER2-targeted T-cell engager with PRO-XTEN masks that are removed by proteases in tumours.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/amx-818/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"amunix-pharmaceuticals","kind":"company","name":"Amunix Pharmaceuticals","route":"/companies/amunix-pharmaceuticals/"},{"id":"merck-kgaa","kind":"company","name":"Merck KGaA (EMD Serono)","route":"/companies/merck-kgaa/"},{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}],"trial":[{"id":"nct05356741","kind":"trial","name":"To Access the Safety and Effects of Intravenous Administration of VIR-5818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers","route":"/trials/nct05356741/"}]}}