AggieFab and BrYet US, Inc. Propel Cancer Therapy Forward

The AggieFab Nanofabrication Facility at Texas A&M University is making significant strides in cancer research through its collaboration with BrYet US, Inc. Together, they are advancing a promising silicon-based cancer therapy, known as ML-016, which targets aggressive lung and liver cancers. This partnership merges advanced semiconductor technology with biomedicine, aiming to improve treatment outcomes for patients facing these challenging diseases.

AggieFab’s cleanrooms provide a specialized environment essential for developing therapeutics. These cleanrooms maintain controlled air temperatures, humidity levels, and minimal vibrations, which are crucial for the precision needed in nanofabrication. BrYet’s innovative therapy utilizes nanoporous silicon microparticles (NSMPs), engineered to deliver chemotherapy directly to tumors while degrading harmlessly into silicic acid. According to BrYet Chief Technology Officer Brian Sapp, “These bio-erodible particles are designed to navigate biological barriers, delivering drugs directly to tumors.”

ML-016 combines NSMPs with a polymer-doxorubicin conjugate, which is a chemotherapy agent. In preclinical models, this therapy has achieved “functional cures” in 50% of treated mice, indicating long-term tumor-free survival. This outcome presents a hopeful prospect for patients suffering from treatment-resistant metastatic cancer.

To facilitate the transition of ML-016 towards human trials, BrYet required a semiconductor-grade cleanroom able to support specialized NSMP nanofabrication processing. After evaluating various facilities across the United States, they selected AggieFab for its advanced infrastructure and collaborative research environment. Sapp stated, “Collaborating with AggieFab provided the specialized environment, infrastructure access, and partnership mindset required to advance our program efficiently and on schedule.”

AggieFab boasts over 6,500 square feet of Class 100/1000 cleanroom space, equipped with cutting-edge micro- and nanofabrication tools developed over two decades. This facility receives support from the Texas A&M College of Engineering and the Texas A&M Engineering Experiment Station. Dr. Arum Han, director of AggieFab, expressed gratitude for the recent investment in equipment and infrastructure through the Texas CHIPS Act, emphasizing its role in bolstering local industry and advancing product development in biotechnology.

BrYet established its operations at AggieFab in October 2023, integrating its commercial nanofabrication workflow into the academic cleanroom. The company installed specialized equipment, including electrochemical etching systems and characterization tools, which enhanced AggieFab’s existing capabilities. This collaboration has allowed BrYet to conduct vital studies, crucial for paving the way to clinical trials.

Recently, BrYet received approval from Australia’s Human Research Ethics Committee to commence a Phase 1/2 trial of ML-016 for patients with advanced lung and liver cancers. Enrollment for this trial is expected to begin in 2026, marking a significant step forward for the therapy and its potential impact on patient care.

Sapp concluded, “We are proud to partner with AggieFab in our mission to deliver functional cures for advanced cancers,” thanking the Texas A&M team for their support. This collaboration not only advances cancer research but also provides Texas A&M students with invaluable hands-on experience in semiconductor processing for biomedical applications through an internship program with BrYet.