BrYet Files IND for Lead Oncology Therapeutic ML-016

New drug targets advanced solid tumors with lung and/or liver metastases

Published on Mar. 4, 2026

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BrYet US, Inc., a biotechnology company focused on developing curative therapies for advanced cancers, has filed an Investigational New Drug (IND) application with the FDA for its lead drug candidate ML-016. The IND will support the expansion of BrYet's clinical program for ML-016, which has shown strong therapeutic efficacy in preclinical models for treating cancers involving the lungs or liver.

Why it matters

The filing of this IND represents a major milestone for BrYet, bringing the company closer to delivering new treatment options for advanced cancer patients. ML-016 utilizes BrYet's proprietary platform for targeting cancer-associated transport phenotypes, which the company believes may provide advances against other presently incurable cancers as well.

The details

ML-016 is an amino acid-drug conjugate that includes BrYet's proprietary Si-Plateiod technology, designed to target the vascular endothelium of blood vessels in the tumor microenvironment. The drug is intended to be preferentially taken up by cancer cells, including those resistant to previous therapies, and released into the cell nucleus to exert its cytotoxic effects.

  • BrYet received Australian approval last year to begin a first-in-human clinical study of ML-016, with the first patient dose expected in Q2 2026.
  • The U.S. IND filing will now allow BrYet to expand the ML-016 clinical program with a focus on specific indications.

The players

BrYet US, Inc.

A privately held biotechnology company developing potentially first-in-class therapies for patients suffering from cancers for which there is no current curative treatment.

Dr. Mauro Ferrari

President and CEO of BrYet, who stated that the IND filing is a major step forward for the company in delivering new therapeutic options for advanced cancer patients.

ML-016

BrYet's lead drug candidate, an amino acid-drug conjugate designed to target the vascular endothelium of blood vessels in the tumor microenvironment.

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What they’re saying

“Submitting our first IND application is a major step forward for BrYet, bringing us closer to delivering new therapeutic options for advanced cancer patients worldwide.”

— Dr. Mauro Ferrari, President and CEO of BrYet

What’s next

Upon FDA approval of the IND, BrYet will expand its ML-016 clinical program with additional trials in the United States, focusing on specific indications.

The takeaway

BrYet's innovative approach to targeting cancer-associated transport phenotypes holds promise for advancing treatments for advanced solid tumors, including those with lung and liver metastases, where current options are limited.