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.
Arbomatix© LLC (A-LLC) was formed in July 2011 with the objective of developing and marketing a range of biomedical products. This Phase I SBIR was aimed at scaling up a "green" chemical process to produce compounds for the synthesis of molecules capable of finding and destroying cancer cells while leaving healthy cells alone. The graying of America will swell the number of cancer patients and survivors by 55% by 2020, according to a study that suggests doctors may not be able to cope with the additional burden. Studies show that the number of Americans who are diagnosed with cancer — both those in treatment and those who have finished therapy — will grow to 18.2 million, up from 11.7 million in 2005. Today, about one in 26 Americans has had cancer. By 2020, one in 19 will have been diagnosed with the disease. Special interest to Arbomatrix LLC has been breast cancer, the most frequently diagnosed cancer in both white and African-American women. One in eight American women develops breast cancer, and every 3 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. Cancer treatment and diagnosis using the "magic bullets" to be developed from the products made and characterized in this Phase I project will have a major impact by minimizing the devastating side effects on the patient and his/her family. The impact on health care is expected to be very significant. Tetraethylene-glycol (TEG)-based molecules with 4 and 8 functional groups in the outer corona were successfully made and characterized in the phase I project. These functional groups will be used to produce the "magic bullet" that will find and destroy cancer cells. The scalability of the "green" enzyme-catalyzed reactions was demonstrated in a 5 L reactor – 4 kg of the molecule with 4 functional groups was produced without the use of solvents. The Phase II proposal will be built on this new molecule. In addition, the versatility of the technology was demonstrated by producing several potential molecules on a smaller scale. All steps produced very pure products with high efficiency (> 90%). We also partnered with Quanta BioDesign Inc. who has long-term experience in drug development, and PolyInsight LLC who will lead the Phase II effort.
