# ML-016

Source: https://onco.cc/drugs/ml-016/  
OnCo record `ml-016` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-1
- Last checked: 2026-11-03
- Also known as: iNPG-pDox
- Tags: pipeline; ctgov-ingest
- 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.

## Sources

- BrYet: bryetpharma.com: https://bryetpharma.com/technology/
- BrYet: bryetpharma.com: https://bryetpharma.com/technology/
- BrYet: bryetpharma.com: https://bryetpharma.com/2026/09/bryet-announces-aifa-approval/
- BrYet: clinicaltrials.gov: https://clinicaltrials.gov/api/v2/studies/NCT07723482
- ClinicalTrials.gov: trials of ML-016: https://clinicaltrials.gov/search?intr=ML-016

## Connected records

- cancers: [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/)
- companies: [BrYet](https://onco.cc/companies/bryet/)
- trials: [ML-016 in Advanced Cancer With Lung and/or Liver Involvement](https://onco.cc/trials/nct07723482/)

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JSON: https://onco.cc/api/v1/entities/ml-016.json