One day in the not so distant future, many of the 50,000 Americans destined to be diagnosed with head and neck cancer annually, as well as millions at risk, could learn with a simple gargle-and-spit test that they could develop the deadly disease long before the first lesion appears in their mouth. If so, the lifesaving breakthrough will have been made possible by the innovative clinical research of a Miller School otolaryngologist, the entrepreneurial passions and personal pain of a Georgia attorney, and the service-oriented invention clearinghouse that brought them together and enabled their success.

Formerly called the Office of Technology Transfer, the newly christened office for Intellectual Property Strategy & Licensing, or IPSL, navigated the diagnostic technology that Elizabeth Franzmann, M.D., associate professor of otolaryngology, developed in 2002 through the bewildering patent process and into the hands of Matthew H.J. Kim. An intellectual property attorney by training and an entrepreneur by passion, Kim is as determined as Franzmann to spare others the painful and disfiguring surgeries his mother endured while battling squamous cell carcinoma. He founded Vigilant Biosciences, Inc. (VigilantBIO), an award-winning start-up, to bring the low-cost test to dentists’ offices, primary care practices, and drug stores everywhere.

In the preliminary test Franzmann developed and has used in several clinical trials, patients simply rinse 5 CCs – a teaspoon – of saline into their mouth, swish for five seconds, gargle for five seconds, then spit into a collection tube. The saliva solution is then analyzed for the presence of at least two markers that Franzmann, under the original guidance of Vinata Lokeshwar, M.D., professor of urology, showed were early indicators of squamous cell carcinoma. The most common oral cancer, squamous cell carcinoma is often linked to tobacco and alcohol use, and increasingly, the human papillomavirus (HPV) that causes cervical cancer.

“Even though we can’t see the cancer with our eyes, we could detect it with the rinse,” Franzmann said. “The earlier we can detect it, the earlier we can intervene.”

Oral cancer has a higher death rate than many other cancers not because it is so difficult to diagnose, but because it is too often discovered late in its development, a fact that propelled Franzmann through 10 years of obstacles and setbacks, including a nearly disastrous disclosure of intellectual property, to develop an easy-to-administer test.

In what could serve as a cautionary lesson for other University researchers, Franzmann didn’t think twice when, early in the process, she mentioned an initial biomarker in a grant abstract, which became public when the grant was funded, negating her possible patent.

As Christine Neipert, Ph.D., a licensing manager for the University who is also a registered patent agent, explains, “U.S. patent law states that what is already in the public domain before an application is on file can’t be patented, because it’s no longer deemed ‘novel,’ and Dr. Franzmann’s abstract prior to our initial patent application filing put her original discovery in the public domain.”

Fortunately, Franzmann found additional biomarkers, which in combination with the first biomarker turned out to be a better indicator of cancer than the original one alone. In January of this year, with IPSL’s assistance every step of the way, she and Lokeshwar were awarded a patent for the use of the markers as a diagnostic tool.

By then, Kim’s efforts to bring their discovery to the marketplace were already underway, thanks to IPSL’s marketing. Led by Elizabeth Fenjves, Ph.D., professor of medicine, the office, which will soon move from Dominion Tower to the Life Science & Technology Park, reviews novel faculty inventions, applies for patents, and scouts for commercial partners by actively marketing the University’s available technologies.

Mining the Internet for possible bioscience technologies to nurture, Kim found the gargle-and-spit test on the office’s website in the fall of 2010 and was immediately interested for the most personal reasons. Both of his parents are oral cancer survivors, and his mother, who didn’t smoke, drink nor have HPV, suffered through three increasingly aggressive bouts. Now in her mid-70s, she is finally completing the last phases of jaw reconstruction after enduring intense surgery, radiation and chemotherapy.

“My mom has eaten mostly porridge and shakes for the past three years, and struggled to speak after doctors ultimately had to remove part of her tongue and jaw, replacing it with a steel plate and a bone and tissue graft from her leg,” Kim said, his voice cracking with emotion. “I saw a lot of different technologies for other types of cancer; when I saw this and realized how far Dr. Franzmann had advanced the research and moved the technology along, everything seemed right for me to move forward.”

Eight months later, Kim signed a licensing agreement with the University, which gives VigilantBIO exclusive rights to Franzmann’s patented technology. Today, the gargle-and-spit test, which still needs FDA approval, more investors and a number of refinements, is two to three years away from being commercially available. Yet VigilantBIO already is emerging as one of IPSL’s most successful spin-off companies.

In March, the company won the life science category of the Association of University Technology Managers’ prestigious international business plan competition for academic start-ups, which included a $10,000 prize in addition to the high-profile recognition.

And in late April, VigilantBIO received conditional approval from the Florida Institute for the Commercialization of Public Research for a repayable loan of up to $300,000 through its Seed Capital Accelerator Program. The loan is contingent upon VigilantBIO securing qualified matching funds from private investors.

Neipert says it’s not hard to understand why. As she notes, combining lifesaving technology with committed partners like Franzmann and Kim, and the experienced team of industry, management and product development executives he’s put together, is almost a sure bet.

“Academic start-ups need more than patents and money. They need the right people,” she said. “In fact, a lot of venture capitalists will say, ‘I’ll take a B technology with an A team over an A technology with a B team. Here we have an A technology and an A team.”

Noting that “the efforts, tenacity and stubborn belief in the potential of this technology by many people brought us to this point,” Fenjves added that “many other great ideas do not get here because the odds are so difficult to overcome.”

Source: University of Miami