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The OncAlert oral cancer product line from Vigilant Biosciences Inc, Fort Lauderdale, Fla, is now available in select markets. The company’s OncAlert oral cancer product line includes the OncAlert oral cancer rapid test and the OncAlert oral cancer lab test, available in countries accepting the CE mark. The tests are based on technology that accurately measures CD44, a tumor-initiating and stem cell-associated biomarker, and total protein levels—markers clinically validated to be associated specifically with oral cancer. The tests are optimized for easy use by collecting samples via an oral saline rinse, and are performed via either a point-of-care lateral-flow assay or a laboratory kit. The test results, along with other clinical factors, can aid in the early diagnosis of oral cancer, potentially even before visual or physical indicators. According to a company spokesperson, Vigilant Biosciences has plans to pursue FDA approval on the OncAlert oral cancer product line in the near future. For more information, visit Vigilant Biosciences.

For Matthew Kim, the idea for his company came when he was taking his mother to doctor visits for her cancer treatments.

She was on her third battle with oral cancer, while Kim had a consulting firm and the fortunate flexibility to take her to her chemotherapy, radiation and rehabilitation.

 

 

 

 

 

When Matthew Kim, founder and CEO of Vigilant Biosciences in Fort Lauderdale started his company in 2011, he quickly found funding to be a serious challenge. Ultimately, he persuaded an out-of-state investor to help, but in his most recent financing round, he received support from venVelo, an early-stage angel fund in Orlando, the Florida Institute for Commercialization of Public Research, and some wealthy individuals in South Florida.

The Mistake:

I fell in love with a technology before understanding the impact or value the technology can have in the real world.

In my prior medical startup, I created a drug delivery platform which had a very novel way of delivering medication to the lungs systemically. I licensed and started the company and raised money, really just to promote the technology without looking at why the technology had an impact or value. After spending a lot of time and money developing the product, we simply weren’t finding a niche that it could be leveraged for. By the time we did, it was very difficult to continue to maintain the momentum, and unfortunately, I was unable to take that product to the full potential it could have had.

When I came across the technology we are creating at Vigilant, it didn’t really start with the technology itself, but rather it started off with the need for it. Both my parents are oral cancer survivors: My mom is a stage 4 survivor and my dad is a stage 2 survivor, so their struggle is very personal to me. Watching my mom’s battle, in particular, was very emotional and very heartbreaking, not only in her battle with the disease but in overcoming the new normal she had to live with.

When she was going through it, I was wondering why she had to go through this ordeal, and why so many people were finding out they had cancer far too late. So I started looking at the technologies and the products on the market, and they had great applications and science behind it, but they weren’t addressing the unmet need for early accurate attention.

So instead of trying out technologies and seeing what fits, because the unmet needs were very personal to me, I started looking at what was being researched and what was being developed in various centers of excellence. Once we developed our Vigilant technology, then we were looking at the ways we can leverage the technology across different platforms to really address the needs of front-line screeners, who are at the forefront of detecting whether someone has cancer.

The Lesson:

I tell fellow entrepreneurs, don’t fall in love with a technology and then see where it fits. Instead, find what breaks your heart, what angers you or makes you passionate, understand why that is and see if it translates to an unmet need, and then find the right solution for that. Oftentimes, if you focus on that unmet need instead of the technology itself, it gives you the flexibility to find complementary technologies, gives you the opportunity to pivot, rather than trying to find this one technology or trying to make it fit everything.

If I had learned that in my prior startup, I would have positioned the business plan around that, as opposed to trying to get people excited about the technology itself without really pointing out the unmet need that it was addressing.

After learning this lesson, we’ve been able to move forward with Vigilant. The company has been so much more successful, and my experience has been much more successful because we were moving with a product that meets an unmet need first and foremost.

According to the World Health Organization, there are more than 529,000 new cases of oral (lip, oral cavity, and pharynx) cancer each year worldwide, with mortality rates reaching up to 292,000 deaths each year.1 In the United States, more than 48,000 individuals will be diagnosed with oral cancer this year with more than 9,500 deaths resulting from this disease, killing roughly one person per hour, 24 hours per day.2

Historically the death rate associated with this cancer is particularly high due to late-stage diagnosis and intervention. Currently, the vast majority of patients with oral cancer 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%.3

While all adults should be screened for oral cancer annually, those who smoke or use smokeless tobacco and/or consume alcohol excessively are at a higher risk for the disease. Another risk factor is exposure to certain types of human papillomavirus (HPV), a common sexually transmitted virus that is contributing to a rise in oral cancer among young adults.

A recent consumer survey on oral cancer showed that while only about a third of those surveyed recall being screened for oral cancer at their last dental checkup, a large majority would like to be screened at every checkup and would like their dental professional to use simple screening tools to assess their risk.

Current Screening Approach 

The current standard for screening for oral cancer is a visual/manual oral examination given by the dental or medical professional as part of the annual checkup. This head and neck examination entails bimanual palpation of various external areas of:

  • The head and neck including the lower jaw, neck, glands, and lymph nodes of this area;
  • The oral cavity including the tongue, cheeks, floor and roof of the mouth, lips, and back of the throat.

During this examination, screeners look for clinical features of oral lesions that might raise suspicion of potential malignancy, including sharp or distinct margins, a red component (color variation), a non-homogenous white component (surface irregularity), persistent ulceration, and size larger than 1 centimeter. The clinician also should view with suspicion any persistent or progressive lesion of the ventrolateral tongue or the floor of the mouth. If any of these types of areas are present, the exam is followed up with a biopsy for any suspicious lesions.

Although the oral cavity is easily accessible for examination and evaluation, the ability to identify this disease in its earliest stages can be very difficult, as early-stage lesions may often be asymptomatic or mimic other conditions, whereas other lesions may not be readily evident in routine examination. Finding the disease in its earliest stages with this screening method therefore is not easy and has often eluded the medical and dental professions.

While there are several types of adjunctive tools that have attempted to address earlier intervention, to date they have all fallen short of making a significant dent in oral cancer mortality rates.

Light-based system options include spectroscopic and chemiluminescent (light-based aid requiring the use of acid or dye). This type of evaluation requires extensive training; it is labor intensive and time consuming for the dentist or dental professional. There is also an available saliva-based test for use when a lesion has already been detected. However, that test misses the opportunity to test prior to a lesion appearing and does not test for specific tumor-initiating stem cell-associated biomarkers.

Today, there are some innovative new tools being introduced that show promise for earlier detection for oral cancer.

One of these is a new test based on technology that measures an unprecedented combination of CD44 and total protein levels, markers clinically validated to be associated specifically with oral cancer, to aid clinicians in the early detection and intervention of oral cancer by assisting in clinical decision-making. This new, promising technology, which uses a combination of CD44 and total protein, makes it easy for dental professionals to incorporate stem cell-associated biomarker information into clinical practice.

This oral rinse-based test is simple for the dentist or dental professional to administer, as well as for the patient to use. Patients swish and gargle an oral solution in their mouth for 10 seconds, the sample is collected in the specimen cup, and then a test cassette is inserted into the specimen cup. Results can be read on the test cassette at 20 minutes.

Conclusion 

It is of the utmost importance for dentists and dental professionals to become educated on the proper methods for oral cancer screening. To help save lives, they should also be encouraging their patients to get screened regularly, especially if they are at higher risk. In addition, new technology based on a stem cell-associated biomarker may assist clinical decision-making, thus aiding in the early detection and intervention of oral cancer.

References 
1 Oral Cancer Foundation – August 2016 and American Cancer Society Facts and Figures 2016

2 WHO 2014 – 2015 World Cancer Report

3 Pereira LH, Reis IM, Reategui EP, Gordon C, Saint-Victor S, Duncan R, Gomez C, Bayers S, Fisher P, Perez A, Goodwin WJ, Hu JJ, Franzmann EJ. Risk Stratification System for Oral Cancer Screening. Cancer Prev Res(Phila). 2016 Jun;9(6):445-55.

Elizabeth Franzmann, MD, serves as the scientific founder and chief scientific officer of Vigilant Biosciences. In addition to her clinical research activities, she is the director of head and neck research at the Sylvester Comprehensive Cancer Center, part of UHealth – the University of Miami Health System. Also, she is certified by the American Board of Otolaryngology specializing in otolaryngology and head and neck surgery as an associate professor of otolaryngology at the University of Miami Miller School of Medicine. She received her bachelor of science and doctorate of medicine at the University of California, Los Angeles. The University of Miami and Dr. Franzmann hold intellectual property (IP) used in the study and have the potential for financial benefit from its future commercialization. Dr. Franzmann also is an equity holder in Vigilant Biosciences, licensee of the IP used in the study.

Florida’s startup and expanding companies so far this year have raised $1 billion in venture capital and angel investments, more than double 2015’s total of $459.89 million, according to a MoneyTree Report released Friday.

While on track for the best year since 2000, Florida companies’ venture capital during the third quarter is less than 1 percent of the total. During the quarter ending Sept. 30, 18 companies raised $92.76 million, compared with 13 companies raising $182 million for the third quarter in 2015.

From January to September, 57 companies have raised $1.05 billion compared with 61 companies raising $459.9 million during last year. The MoneyTree Report by PricewaterhouseCoopers is based on data from Thomson Reuters.

“Florida is going in a good direction,” said Darach Chapman, partner in the deals practice of PricewaterhouseCoopers in Miami. “We’re seeing an increase in number of deals and investments in early stage opportunities. That says to me we’re generating more quality opportunities and ideas in the state.”

While investment dollars are up, Chapman said the average in quarterly deals also is at the “highest run rate in the last 15 years.”

In South Florida, the largest amount of venture capital, $40 million, was raised by PodiCare Services, a provider of wound management services in Hollywood that is also known as Woundtech. The investment was from Aldrich Capital Partners in Bethesda, Md.

 

Other big venture capital deals in the region included:

Biopharmaceutical company Altor BioScience in Miramar raised $14.2 million from an undisclosed investor.

Hosting service Nymbus in Miami Beach raised $12 million from an undisclosed investor.

Cybersecurity company Zenedge raised $6.2 million from Pilot Growth Equity Partners, TELUS Ventures and other undisclosed firms.

Financial services company Iatai Enterprises in Boca Raton raised $5 million from Lafise Investment Management.

Fort Lauderdale-based Vigilant Biosciences, which has developed products for early detection of oral cancer, raised $1.76 million during the quarter. Vigilant, founded in 2012, has raised a total of $12.5 million in financing, including a $5 million round in the second quarter.

Statewide, 10 of the third-quarter investments were in early-stage companies, while two were in the expansion stage and one in a later stage of development.

Nationwide, venture capitalists invested $10.6 billion in 891 deals in the third quarter of 2016. Dollars and deals were down 36 percent and 25 percent, respectively, during the third quarter compared with a year ago, according to the report.

San Francisco-based, short-term lodging business Airbnb was the top deal in the quarter, raising $556 million from an undisclosed firm. Including Airbnb, there were 10 “mega-deals” of $100 million or more.

This is the 11th consecutive quarter of more than $10 billion in venture capital invested in a single quarter, and the second time the deal count has dropped below 1,000 since the first quarter of 2013.

“The decline in venture capital activity this quarter is part of the normalization process that is expected after a quarter in which record-breaking investments dominated headlines,” said Tom Ciccolella, U.S. venture capital market leader at PricewaterhouseCoopers.

Vigilant Biosciences, a developer of solutions that aid in the early detection and intervention of cancer, has received a Phase I Small Business Innovation Research grant of $219,454 from the National Institute of Dental and Craniofacial Research.

The 15-month grant will fund research by Vigilant Biosciences to develop a diagnostic test that utilizes optical imaging and an oral rinse to detect CD44, a tumor-initiating and stem cell-associated biomarker for oral cancer.

Vigilant Biosciences’ current product line is based on patented technology that measures a combination of CD44 and total protein levels—markers clinically validated to be associated specifically with oral cancer when measured in an oral rinse—to aid clinicians in the early detection and intervention of oral cancer.

The Phase I preclinical study will include in vitro work as well as human tissues from cancer patients and patients with benign disease of the throat.

Head and neck cancer is a growing challenge with more than 650,000 new cases and more than 360,000 deaths worldwide each year.

Historically, the death rate associated with this cancer is particularly high due to late-stage diagnosis and intervention. More than 40 percent of those diagnosed with oral cancer die within five years.

Vigilant Biosciences, an oral cancer testing company, announced that it has raised a total of $10.5 million in Series B financing.

The second phase of the Series B round brought in $5 million and investors in this phase included White Owl Capital Partners, venVelo and others. Investment in this round also came from a group of private and angels, according to a news release from the company.

Fort Lauderdale startup Vigilant Biosciences has raised $5 million from investors, bringing its total amount raised to $12.5 million to date, the company said Monday.

The money will be used for commercial development of the company’s OncAlert oral cancer detection product line.

Vigilant Biosciences is developing products for the early detection and intervention of cancer. On Monday, the Fort Lauderdale life sciences company announced it closed a $5 million round of financing, bringing its total amount of funding raised to date to $12.5 million.

When technologies have matured to the point of market readiness, it can be hard to keep track of the many new products that suddenly become available to the marketplace. This spring, after many months of anticipation, early FDA approvals hint that the floodgates for so-called “liquid biopsy” technologies are about to be thrown wide open.