The Fort Worth Press - BrYet US, Inc. Receives Approval to Initiate in Australia a First-in-Human Phase 1/2 Trial of ML-016 in Advanced Cancers with Lung and/or Liver Involvement

The open-label, dose-escalation and expansion study, titled "A Phase 1/2 Study of ML-016 in Participants with Advanced Cancer with Lung and/or Liver Involvement," is authorized to commence in Australia with the University of the Sunshine Coast (UniSC) Clinical Trials as the lead site. BrYet expects the trial enrollment to begin in early 2026. The drug, ML-016 is manufactured and formulated at NerPharMa in Nerviano, Italy.

"Securing HREC approval is a critical milestone that brings us closer to providing hope of improved health to patients suffering from cancers of the lungs and liver, including metastatic lesions originating from other organs or tissue in the body," said Dr. Mauro Ferrari, the President and CEO of BrYet. "Furthermore, it supports our innovative approach to oncology, based upon targeting the molecular transport phenotype of cancer lesions in the lungs and liver."

ML-016 comprises an amino acid polymer conjugated to doxorubicin, with a formulation that includes platelet-like bio-erodible mesoporous silicon elements, which 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. In preclinical studies, BrYet demonstrated that by way of these combined mechanisms of action and transport, 50% of laboratory animals with otherwise uniformly lethal metastatic burden achieved long-term survival.

The Phase 1 portion of the trial will evaluate the safety, tolerability, and pharmacokinetics of ML-016 and identify two doses recommended for expansion into Phase 2. The Phase 2 expansion portion of the trial will include disease specific cohorts planned to explore preliminary antitumor activity in advanced solid tumors involving the lungs and/or liver. The trial will be led by UniSC Principal Investigator Dr. Brenton Seidl who believes metastatic cancer involving the lungs or liver remains one of the most complex challenges in oncology.

"This trial offers hope for those who have exhausted standard treatment options and allows us to investigate a potential new approach that may improve outcomes for patients with advanced solid cancers," Dr Seidl said.

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About BrYet US, Inc.

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 mesoporous silicon components, 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 about BrYet, please visit the company's website: https://bryetpharma.com/

About UniSC Clinical Trials

UniSC Clinical Trials operates a growing clinical trial site network across the Sunshine Coast and surrounding regions, including specialist oncology trial capabilities. UniSC Clinical Trials works with local and global medical experts and industry to bring advanced treatments and therapies to life, and make cutting-edge medical research accessible to everyone.​ For more information, visit https://www.usc.edu.au/community/unisc-clinical-trials-clinical-trial-site-network

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 & Investor Contact
BrYet US, Inc.
[email protected] | bryetpharma.com
2450 Holcombe Blvd., Suite 1520, Houston, Texas 77021, USA

SOURCE: BrYet US Inc.

View the original press release on ACCESS Newswire

T.Harrison--TFWP