BrYet US, Inc. (“BrYet”) — a biotechnology innovator focused on developing curative therapies for advanced cancers — announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its lead drug, ML-016. Upon approval, the IND will support the expansion of BrYet's ML-016 clinical program with additional trials in the United States.
“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,” said Dr. Mauro Ferrari, president and CEO of BrYet. “This milestone reflects decades of scientific research behind our unique approach to treating cancer, based on our proprietary platform for targeting phenotypes.”
Last year, BrYet received Australian approval to begin its first-in-human clinical study of ML-016. The broadly scoped Phase I/II trial will enroll patients with any primary or metastatic cancer involving the lungs or liver, with the first patient dose expected to be administered in the second quarter of 2026. The U.S. IND will expand the clinical program with a focus on specific indications.
ML-016 has shown strong therapeutic efficacy in preclinical models, achieving long-term survival in about 50% of test animalsin multiple metastatic tumor models. GLP preclinical data reconfirmed the strong safety profile of ML-016 and BrYet's platform for targeting phenotypes.
About ML-016
ML-016 is comprised of an amino acid polymer conjugated to doxorubicin with a formulation that includes BrYet's proprietary Si-PlateloidTM technology, designed to target the vascular endothelium of blood vessels in the tumor microenvironment. The amino acid-drug conjugate is released into the tumor, where it forms exosome-like vesicles.
These “exosomoids” are designed to be preferentially taken up by cancer cells including those that have previously been resistant to therapy. Through the mechanisms of cellular trafficking, the exosomoid vesicles are intended to be transported to late-stage endosomes and lysosomes, where the increased acidity releases the cytotoxic agent into the cell nucleus.
About BrYet
BrYet is a privately held biotechnology company developing potentially first-in-class therapies for patients suffering from cancers for which there is no current curative treatment. BrYet’s lead asset, ML-016, is being developed for cancers of the lungs and liver, including advanced primary malignancies and metastatic spread from primary cancer that originates in other organs or tissue of the body. The company’s fundamental belief is that upon localization in the lungs and liver, these cancers acquire molecular transport phenotypes that are conserved regardless of site of origin and are largely independent of molecular mutations and their continued evolution. BrYet designs multi-component new chemical entities and formulations, which are directed against the fundamental aspects of these cancer-associated, organ-specific transport phenotypes. The company’s proprietary platforms include the Si-PlateloidTM and the mathematical formalism for designing the multi-component drugs, termed Transport Oncophysics. BrYet believes that similar approaches may provide advances against other forms of presently incurable cancers, as well as other pathologies of the lungs and liver. For more information visit bryetpharma.com.
Safe-Harbor Statement
This press release contains forward-looking statements concerning BrYet and its business. These statements are based on the beliefs of, assumptions made by, and information currently available to the company’s management. When used in this document, the words “expects,” “anticipates,” “estimates,” “intends,” “believes,” “plans,” “predicts,” “should,” “could,” “will,” and similar expressions are intended to identify forward-looking statements.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ from expectations. Factors that could contribute to these differences include the results of studies and clinical trials, regulatory approvals, challenges in clinical trials, the ability to retain employees, research and development expenses, reliance on third parties, intellectual property issues, competition, future funding needs, economic conditions, and other industry-specific risks. You should not place undue reliance on these statements, which are current as of the date of this press release. BrYet does not plan to update these statements unless legally required.
Media and Investor Contact
BrYet US, Inc.
2450 Holcombe Blvd., Suite 1520, Houston, TX 77021, USA
info@bryetpharma.com
