Keystone Nano, with Help from Ben Franklin Technology Partners, Sets Sights on Liver Cancer

Jeff Davidson, Keystone Nano Founder and CEO

Keystone Nano is targeting a killer that claims approximately 700,000 lives each year, with no effective treatment—liver cancer. With the company’s recently unveiled Ceramide NanoLiposome (CNL), they expect to be able to effectively kill cancer cells, while leaving normal cells unharmed, a process nearly unheard of in the world of cancer therapies. This means great things for cancer patients, including reduced negative side effects that result from most traditional cancer treatments, as well as a greater likelihood of treatment success.

Of course, Keystone Nano may have never gotten to where they are today without the assistance of one of our Innovation Park residents. “Ben Franklin Technology Partners has been extremely important to Keystone Nano, providing some of our earliest funding and supporting the growth of our company with a range of strategic service. Ben Franklin funding primed the pump, allowing Keystone to secure grants, pharma-sponsored research, and equity investments of $12 million, and is facilitating the development of a therapeutic which could have sales of many hundreds of millions of dollars,” says Jeff Davidson, Keystone Nano founder and CEO.

Davidson has an impressive resume under his belt, with years of vital experience preceding his venture into the world of cancer treatments. With degrees from Purdue and the University of Minnesota, he went on to establish more than 30 years of experience in the industry, including stints as the executive director of the Penn State Bioprocessing Resource Center; founder of the Pennsylvania Biotechnology Association; publisher of a biotechnology applications magazine; and founder of a national biotechnology education nonprofit.

Ceramide NanoLiposome is a
new approach to cancer therapy.

It was in 2005 that he turned his attention to Keystone Nano, a company which has spent the last 11 years or so working toward their goals of fighting cancer. It was Dr. Mark Kester, Keystone Nano’s chief medical officer and director of NanoSTAR at the University of Virginia, who first developed the Ceramide NanoLiposome. Now, Dr. Kester is publishing extensively on its existence, allowing others to study his findings around the world. Keystone Nano has taken his work, scaled up production, conducted 13 large-scale safety studies and submitted an Investigational New Drug application to the FDA.

While the substance has shown positive results in animal models of cancer, the next step is to conduct a Phase I trial of Ceramide NanoLiposome, to discover what would be the most appropriate human dosage. The FDA gave Keystone Nano approval to begin their human trials at three universities, and the trials are set to take place at the University of Maryland, University of Virginia, and Medical University of South Carolina.

The National Cancer Institute recognized Keystone Nano’s work, and granted them a $2 million small business investigational research grant.

“Patients will be recruited and a dose escalation trial will be conducted to find the appropriate dose. Somewhere between 18 and 48 patients will participate in this study, and we anticipate the number will be closer to the minimum than the maximum. The study is expected to take 18 months; however, we will learn a great deal in the first six months of clinical testing,” says Davidson.

After discovering the further effects that Ceramide NanoLiposome has on patients, it’ll be easier to format the product for an entirely new type of cancer treatment, specializing it for cancer types beyond liver. Already, the prior animal models have proven positive for breast cancer, pancreatic cancer, melanoma, and leukemia.

However, Ceramide NanoLiposome isn’t the only impressive project currently underway at the company. They’ve also developed what they call NanoJackets, which are created to improve the delivery of a wide array of anti-cancer compounds. Composed of materials that are generally well-tolerated by the human body, such as calcium and phosphate, the NanoJacket protects active, anti-cancer compounds during their delivery through circulation. In addition, the NanoJackets can target specific organs, or be actively guided to organs through precision therapy. This project is supported by grants from the National Cancer Institute for Oncology, and the National Institute of Allergy and Infectious Diseases; the company hopes it will be ready for pre-clinical development in the next year, with early testing showing high effectiveness in breast cancer models. Already, companies are sponsoring the use of NanoJacket technology for internal delivery of their active ingredients. Beyond this promising product, Keystone Nano is working on unique immune therapies, and a range of RNA therapies.

Most recently, the National Cancer Institute recognized Keystone Nano’s work, and granted them a $2 million small business investigational research grant. Davidson and the entire Keystone Nano team see this as a huge vote of confidence in the products, as well as in the team itself.

Davidson acknowledges his Centre County location as crucial to all of these accomplishments. “Keystone Nano is pleased to have a young and energetic team of researchers based near Penn State University creating and testing new anti-cancer therapies each day.”