{"entity":{"id":"ml-016","kind":"drug","name":"ML-016","aka":["iNPG-pDox"],"tldr":"ML-016 is an experimental injectable nanoparticle generator: polymer-doxorubicin conjugate formulated in nanoporous silicon microparticles from BrYet, in phase 1 trials for advanced solid tumours with lung and/or liver involvement.","summary":"ML-016 (iNPG-pDox) is an injectable nanoparticle generator: polymer-doxorubicin conjugate formulated in nanoporous silicon microparticles from BrYet. ML-016 comprises an amino acid polymer conjugated to doxorubicin, formulated with platelet-like bio-erodible mesoporous silicon elements that target the vascular endothelium of tumour blood vessels. The conjugate is released into the tumour, where it forms exosome-like vesicles designed to be taken up by cancer cells. Its furthest stage is phase 1, for advanced solid tumours with lung and/or liver involvement (primary or metastatic). ClinicalTrials.gov registers it in one study linked below. Phase 1/2 NCT07723482 is recruiting per the v2 API (start 2026-09-25); the company says its AIFA-approved manufacturing line will supply the Australian trial. Whether it works in people has not been established unless a trial below reports it.","status":"phase-1","asOf":"2026-11-03","links":[{"label":"BrYet: bryetpharma.com","url":"https://bryetpharma.com/technology/"},{"label":"BrYet: bryetpharma.com","url":"https://bryetpharma.com/technology/"},{"label":"BrYet: bryetpharma.com","url":"https://bryetpharma.com/2026/09/bryet-announces-aifa-approval/"},{"label":"BrYet: clinicaltrials.gov","url":"https://clinicaltrials.gov/api/v2/studies/NCT07723482"},{"label":"ClinicalTrials.gov: trials of ML-016","url":"https://clinicaltrials.gov/search?intr=ML-016"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["bryet"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07723482"],"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":"ML-016","modality":"Injectable nanoparticle generator: polymer-doxorubicin conjugate formulated in nanoporous silicon microparticles","mechanism":"ML-016 comprises an amino acid polymer conjugated to doxorubicin, formulated with platelet-like bio-erodible mesoporous silicon elements that target the vascular endothelium of tumour blood vessels. The conjugate is released into the tumour, where it forms exosome-like vesicles designed to be taken up by cancer cells.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ml-016/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"}],"company":[{"id":"bryet","kind":"company","name":"BrYet","route":"/companies/bryet/"}],"trial":[{"id":"nct07723482","kind":"trial","name":"ML-016 in Advanced Cancer With Lung and/or Liver Involvement","route":"/trials/nct07723482/"}]}}