MetasTx, LLC announced it has received a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to advance development of a diagnostic tool designed to predict metastatic potential in early-stage prostate cancer. The Pittsburgh-based biotechnology company focuses on preventing metastasis of solid tumor cancers including prostate, breast and skin cancers.
The federal award supports MetasTx's multichannel strategy to detect and interrupt cancer metastasis through combined pharmacologic and diagnostic innovation. "This federal grant affirms our approach to addressing one of oncology's most complex challenges," said Harvey D. Homan, CEO of MetasTx. "Our companion diagnostic program has the potential to deliver earlier, more precise insights to clinicians and ultimately improve patient outcomes."
Machine Learning-Based Biomarker Discovery
The NCI-funded project, titled "Epithelial-Mesenchymal Transition Signature Markers (EMTsm) with Machine Learning-Based Analysis as a Predictor of Metastatic Prostate Cancer," aims to identify relevant signature biomarkers and develop methods for their early detection. This proof-of-principle project is expected to be completed by Q2 2026.
Success with the diagnostic program would lead to development of a companion diagnostic to identify prostate cancer patients who are likely to need aggressive treatment to prevent metastasis. The tool could also streamline enrollment into future clinical trials, potentially reducing costs and accelerating the path to FDA approval for the company's novel drug candidates.
Parallel Drug Development Program
MetasTx is simultaneously advancing a pharmacologic development program focused on novel molecules designed and synthesized in the laboratory of Dr. David Crich, PhD. Patent applications have been filed by the University of Georgia Research Foundation, from whom MetasTx plans to license the intellectual property for these compounds.
The company's two lead compounds are currently being tested through biochemical and cellular assays for efficacy and safety under MetasTx's direction. Plans are in place for studies that will support a New Drug Application and likely progression to First-In-Human (Phase 1/2a) clinical studies by late 2027. The company plans to employ generative AI to discover improved next-generation compounds.
Market Opportunity and Clinical Impact
The integrated diagnostic-therapeutic approach positions MetasTx to address a significant clinical need. The company's initial focus targets more than 3 million men in the U.S. with prostate cancer, of which approximately 2 million are under active surveillance for early-stage disease. This patient population represents a potential $11.5 billion market opportunity.
MetasTx's business model emphasizes capital efficiency and strategic outsourcing with a clear path to acquisition. The company is currently seeking to raise $500,000 in a pre-seed convertible note financing round to support ongoing operations and continuation of the drug development program, with a $2 million seed equity financing round planned to follow.
