Matthew H.J. Kim, a patent attorney by training, was heart-broken by the suffering and aggressive treatment his mother went through with oral cancer. He also saw first-hand the results of what he calls an inadequate standard of care resulting in most cancers of the mouth not being detected until stage three or four. A high mortality rate as high as 50 percent could be cut way back with early detection, he believed.

“I felt helpless and wanted to do more … You are fighting great odds by the time you get to that stage,” said Kim.

Then, more than four years ago, with a self-described passion for entrepreneurship, he began researching technologies in development and found one at the University of Miami. After more research and talking to the scientists, he began negotiating the license. “In homage to my mother I executed the license on Mother’s Day of 2011,” he said, and Miami-based Vigilant Biosciences was born.

Since then Vigilant’s products – a point-of-care saliva test and a more quantitative lab test that can aid in the early detection of risk for oral cancer – have been in development, and have passed one of the regulatory hurdles toward commercialization in Europe. On Tuesday, the company announced it has completed its Series B round of funding to fund commercialization in Europe as well as begin the regulatory process in the U.S. this year.

The company’s $5.5 million round of funding brings the total amount of funding raised to date to $7.8 million. The financing includes investments by White Owl Capital Partners, venVelo, the Florida Institute for the Commercialization of Public Research and several existing investors, as well as a group of private and angel investors committed to the life sciences.

Specifically, Vigilant will use the funds to drive toward CE Mark approval in Europe and U.S. regulatory approval for its OncAlert Oral Cancer Risk Assessment System. The funds raised will support the international product launch and commercialization of the OncAlert System as well as other products in Vigilant’s pipeline. “As hundreds of thousands continue to be diagnosed with oral cancer every year, we are committed to providing an accurate, effective and affordable way to aid in the early detection of risk for the disease. This funding will enable us to address this critical market need that has gone unmet for far too long,” said Kim

Vigilant’s initial product, the OncAlert Oral Cancer Risk Assessment System, is based on patented technology that detects specific protein markers known to indicate an elevated risk for oral cancer, even prior to the observation of visual or physical symptoms. The simple, oral rinse procedure is easy to administer and non-invasive for the patient. The test can be applied to every adult, with particular emphasis on high-risk populations, such as current and former tobacco smokers. Both the rapid point-of-care test and the lab assay that comprise the OncAlert Oral Cancer Risk Assessment System are currently under the CE Mark registration approval process in Europe and expected to be released in the second quarter of this year.

“Together, it will be a very effective early detention system for the risk of oral cancer. Our test is a very simple and elegant solution that can be easily integrated into the standard of care,” said Kim. While fortunately his mother is now five years cancer free, others aren’t so lucky. “We are now focused on oral cancer but we believe the technology has promise for other cancers,” said Kim.

According to the World Health Organization, there are over 600,000 new cases of head and neck cancer and 300,000 deaths each year worldwide. Currently, the vast majority of patients are detected through a visual exam and/or are symptomatic, at which point they are likely late stage. As a result, oral cancer often goes undetected to the point of metastasizing. Early diagnosis of oral cancer results in a cure rate of up to 90 percent, the company said.

Dr. Elizabeth Franzmann, an associate professor of otolaryngology at the University of Miami’s Sylvester Comprehensive Cancer Center, is scientific founder and chief scientific officer of Vigilant. Her clinical research on selective salivary biomarkers for head and neck squamous cell carcinoma serves as the foundation for the company’s initial product. The company last week added a vice president of Global Sales and Marketing to the team, bringing executive experience from OPKO Health, Abbott Labs, Novartis and other healthcare companies.

Vigilant, now a team of 10, received support and mentorship from the UInnovation team, led by Norma Kenyon, chief innovation officer at the UM Miller School of Medicine. UInnovation also connected Vigilant with the Florida Institute for the Commercialization of Public Research, which provided the company’s initial seed funding of $300,000 that served as a catalyst to attract more seed capital.

The Institute invested another $200,000 in the Series B round, and like UInnovation, it helped with introductions and access to resources, Kim said.

“Matthew started the company to address the lack of good diagnostics for oral cancer, a disease that both of his parents suffered from,” said Jane Teague, chief operating officer of the Institute. “Vigilant exemplifies what programs like ours are all about, providing seed funding to early-stage companies to bridge the gap until they qualify for and can attract later-stage financing.”

Source: Miami Herald