The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is developing a novel Bacterial Intracellular Delivery (BacID) platform to deliver therapeutic drugs specifically and directly into solid tumor cells, focusing first on the treatment of advanced liver cancer. Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related deaths worldwide. HCC incidence has tripled since 1975 and increased incidence in Western countries is expected due to its link with obesity and diabetes. Almost 75% of HCC patients are diagnosed at intermediate or late stages, and no curative treatment exists. The current clinical therapies extend overall survival by several months before the onset of recurrence or multi-drug resistance, with a cost to the US healthcare system of $1.5 B per year. The platform is based on the inherent feature of bacteria to colonize solid tumors throughout the body in ratios of 100,000 to 1 compared to healthy tissue. This specificity allows the use of proteins with a broad toxicity, reducing off-target side effects. The BacID platform can target intracellular pathways that are currently undruggable and create new clinical therapies for patients that have exhausted all options.

This Small Business Innovation Research Phase II project will further the development of the BacID platform for the delivery of protein drugs to solid tumors. Current delivery vehicles for intracellular targets have several obstacles to overcome, such as stability in the blood and traversing the cell membrane. The BacID platform has the potential to overcome these challenges. This project will create new bacterial strains that can be activated for drug delivery. These strains are designed to modulate efficacy and drug production for optimal drug delivery. Optimization of growth conditions will maximize bacterial fitness and delivery and set the conditions for the development of production according to GMP standards. Combined, these advances will result in the creation of a stable and safe delivery platform for clinical treatment of HCC.

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.

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Ernest Pharmaceuticals
United States
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