ML-016

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.