SBIR Phase I: Green Nanotechnology for Medicine: Scaling up the Synthesis of Novel Poly(ethylene glycol) based Dendrimers for Targeted Drug Delivery Applications

This Small Business Innovation Research Phase I project is aimed at the demonstration of the feasibility of pilot scale production of a novel multivalent theranostic (combination of therapeutic and diagnostic) agent, capable of controlled presentation of multiple targeting ligands by a single nanosized macromolecule for chemotherapeutic applications. The proposing company was founded in 2011 with the objective of developing and marketing a range of biomedical products, based on technologies developed at the University of Akron (UA). The key outcome of the proposed research will be a novel poly(ethylene glycol) (PEG)-based dendrimer, produced by a "green" process using enzyme catalysis under solventless conditions. Specifically, a PEG-based dendrimer with 8 functional groups in the outer corona, available for the conjugation of targeting, imaging/diagnostic and therapeutic agents, will be produced at the two-gallon pilot scale for full characterization by the proposing team. The initial targeted market segment consists of researchers, research chemical suppliers, and companies and organizations doing research to develop new products for targeted drug delivery. The broader impact/commercial potential of this project is significant. Based on data from the National Cancer Institute, the number of Americans who are diagnosed with cancer will grow to 18.2 million. One specific benefit of this technology relates to its potential effects on breast cancer treatment. Breast cancer is the most frequently diagnosed cancer in both white and African-American women. One in eight American women develops breast cancer, and every three minutes a woman in the United States is diagnosed with breast cancer. Systemic treatment of cancer by chemotherapy has many side effects, requiring extended patient care. Targeted cancer treatment and diagnosis will have a major impact by minimizing the devastating side effects on the patient and his/her family. In the near term (3-5 years) we estimate a market potential on the order of $1-1.5 million, based on sales to researchers. In the longer term, the market size can potentially be in the hundreds of millions as the technology becomes embedded in specific products. Finally, the solventless "green" technology will have a positive effect on the environment.