STTR Phase I: A Novel Tissue-Engineered Platform for Cancer Modeling and Drug Screening

The broader impact of this Small Business Technology Transfer Phase I project lies primarily in providing more effective drug screening models to eliminate ineffective drug candidates at an early stage. This may expedite the anti-cancer drug development process and reduce excessive expenses during clinical trials, which may increase the R&D returns for pharmaceutical companies and reduce healthcare costs for the customers.

Furthermore, the sooner that an efficacious anti-cancer drug can be brought to the market, the sooner that patients can directly experience improved health outcomes. Cancer has been one of the leading causes of death in the United States and worldwide. Development of safer and more effective anticancer drugs can provide patients the opportunity for both a longer and potentially better quality of life.

The proposed technology may also have immense value for pharmaceutical companies. In drug development, researchers screen numerous compounds to understand drug efficacy and discard ineffective ones. 90% of drug candidates in the pipeline will fail, in part due to poor clinical translation. The product aims to help companies eliminate inefficacious drugs earlier before millions of dollars are spent on their development.

The proposed project will develop a more physiologically relevant, consistent, and versatile high-throughput screening (HTS) model to improve the translation rate between preclinical and clinical testing. Current drug screening approaches, which rely on two-dimensional (2D) cell cultures and three-dimensional (3D) cell aggregates, fail to provide the necessary microenvironmental cues for accurately replicating human patient drug responses.

Therefore, the proposed technology has been developed, aiming to strike a balance between throughput, which includes scalability and uniformity, and physiological relevance, such as the ability to modulate key attributes of the tumor microenvironment. Utilizing a tissue engineering toolset, the 3D hydrogel scaffold offers a more physiologically pertinent microenvironment for cell growth and drug response.

Meanwhile, a patented microfluidic cell encapsulation platform allows for the rapid and consistent production of the products, which are essential for HTS applications. This project aims to 1) test additional cancer cell types to demonstrate the platform's broad applicability, 2) explore cryopreservation to reduce response time, and 3) transition to commercially available GMP-grade hydrogel precursors to improve reproducibility and scalability.

These R&D efforts are crucial for developing assay-ready kits and services for more efficient drug screening.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.