HOUSTON, Texas — March 4, 2026
BrYet US, Inc., a biotechnology company focused on developing innovative cancer therapies, announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for its lead oncology candidate ML-016, a potential first-in-class therapeutic designed to treat advanced solid tumors involving the lungs and liver. The IND filing marks a critical regulatory milestone that could enable the company to expand its clinical development program in the United States, accelerating research into a novel cancer treatment platform aimed at targeting metastatic tumor environments. If the IND is cleared by regulators, the therapy will advance into additional clinical trials designed to evaluate its safety and effectiveness in patients with aggressive cancers that have spread to the lungs or liver.
IND Filing Advances ML-016 Toward U.S. Clinical Trials
The IND submission represents BrYet’s first regulatory filing with the FDA, signaling a major step forward in the development of its oncology pipeline. ML-016 has already received regulatory clearance in Australia to begin first-in-human clinical studies, and the newly filed U.S. IND would allow the company to expand the program internationally.
According to the company, the Phase I/II clinical trial will enroll patients with advanced cancers that originate in or metastasize to the lungs or liver, including tumors that have spread from other organs. The study is designed to assess safety, tolerability, pharmacokinetics, and early indications of therapeutic effectiveness. The first patient dose in the trial is expected to occur in the second quarter of 2026, pending regulatory authorization.
BrYet’s leadership emphasized that the IND filing reflects decades of scientific research focused on understanding how cancer cells interact with the vascular environment of metastatic tumors. By targeting biological characteristics shared by tumors that localize in the lungs and liver, researchers hope to create a new treatment strategy that is less dependent on individual genetic mutations and more focused on tumor transport mechanisms.
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Novel Drug Design Targets Tumor Microenvironment
ML-016 represents a new class of investigational oncology therapies based on BrYet’s proprietary Si-Plateloid™ technology, which is designed to target the vascular endothelium within the tumor microenvironment. The therapy is composed of an amino-acid polymer conjugated with the widely used chemotherapy agent doxorubicin, engineered to deliver the cytotoxic drug directly to cancer cells.
Once delivered into the tumor environment, the therapy forms exosome-like vesicles known as “exosomoids.” These structures are designed to be selectively absorbed by cancer cells, including those that have developed resistance to conventional treatments. Through natural cellular transport processes, the vesicles move toward late-stage endosomes and lysosomes, where the acidic environment triggers the release of the cytotoxic compound into the cancer cell nucleus, leading to tumor cell death.
This targeted delivery approach aims to increase therapeutic effectiveness while minimizing systemic toxicity, a major challenge in conventional chemotherapy treatments. Scientists believe that precision drug delivery technologies like ML-016 may help overcome treatment resistance and improve outcomes for patients with metastatic cancers.
Preclinical Data Demonstrates Promising Survival Results
Preclinical studies conducted by BrYet have produced encouraging results, suggesting that the therapy could offer significant clinical benefits. In multiple metastatic tumor models, ML-016 achieved long-term survival in approximately 50% of treated test animals, indicating strong anti-tumor activity in aggressive cancer settings.
In addition, Good Laboratory Practice (GLP) preclinical studies confirmed a favorable safety profile, reinforcing confidence in the therapy’s potential to advance into human clinical trials. The company noted that these findings support the broader scientific foundation of its Transport Oncophysics platform, which uses mathematical modeling and biological insights to design multi-component drugs capable of targeting complex cancer transport mechanisms.
BrYet researchers believe that cancers metastasizing to the lungs and liver often develop shared molecular transport characteristics, regardless of their tissue of origin. By focusing on these shared biological features, the company aims to create treatments that could potentially be effective across multiple cancer types rather than targeting a single genetic mutation.
Potential New Strategy for Treating Advanced Metastatic Cancer
Metastatic cancer remains one of the leading causes of cancer-related mortality worldwide, particularly when tumors spread to vital organs such as the lungs or liver. Existing therapies often struggle to control these advanced disease stages due to tumor heterogeneity and resistance to conventional treatments.
BrYet’s approach seeks to address this challenge by targeting fundamental transport phenotypes that allow cancer cells to survive and proliferate within specific organs. If successful, the ML-016 platform could represent a new therapeutic strategy capable of treating multiple metastatic cancers simultaneously, potentially expanding the scope of precision oncology.
With regulatory review now underway, the company is preparing for the next phase of development that could bring innovative targeted therapies closer to patients with advanced cancers and limited treatment options. As oncology research increasingly focuses on tumor microenvironment targeting and advanced drug delivery technologies, therapies such as ML-016 may play a key role in shaping the future of cancer treatment.
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Source: BrYet press release
