Dr. R. Sam Niedbala of TB Biosciences

Keystone Edge — January 9, 2014

His company is close to a revolutionary tuberculosis test that could solve one of global medicine’s oldest riddles.

Every minute, someone in the world dies of tuberculosis (TB). Eradicating this killer disease is a major goal of the World Health Organization, but up until now, there has been no quick, accurate and affordable way to test for active TB.

But if all goes as planned, TB Biosciences — co-founded by Dr. Sam Niedbala of Lehigh University, Drs. Suman Laal and Susan Zolla-Pazner of the New York University School of Medicine, and Drs. Daniel Malamud and William Abrams of the NYU School of Dentistry — will be able to provide just such a test to populations in the most dire need.

Niedbala, a chemistry professor at Lehigh, is a co-founder and former CSO of OraSure Technologies, which manufactures oral fluid diagnostic and collection devices, including rapid tests for detection of the HIV virus.

Now he and his partners are working on a blood testing device that can identify biomarkers for TB, proteins discovered by examining the TB bacteria genome. These markers are only present when TB is active and communicable. They will conduct clinical trials in Kenya and India this year.

What inspired you to start TB Biosciences?

There are probably two infections in the world that are most prevalent. One is HIV, and the second, which is even more impactful in many ways, is tuberculosis. We took on the first (in founding OraSure), and now we’re taking on TB.

Unlike HIV, TB behaves differently in different parts of the body. When it’s latent, it doesn’t show itself very much, but when it becomes active it behaves differently. Researchers have never been able to find a set of markers that show that TB is active, so it’s been impossible to develop a very reliable and rapid test. It has plagued humanity for centuries.

About two-thirds of the world has TB, but it’s latent TB. When it progresses to active TB, you spread it by coughing. In countries where TB is widespread, they need to find out who has active TB, so they can stop the transmission. The treatment methods for TB are actually very inexpensive, so if you can find the people who are positive, you can cure many of them. But you can’t give those drugs to an entire country, because then they can develop drug-resistant strains of TB.

If you take a billion or more people with an infection that they can’t find, it could wreak havoc on a society. TB is endemic in Brazil, Russia, India and China — the world’s fastest-growing economies.

How does your product work?

It’s a small foil pack that contains a little plastic cassette; in that is a test strip. (The clinician) will use a lancet to prick the patient’s finger and get a drop of blood, put it on the test strip, and add a few drops of liquid. In 15 minutes, if there’s a line, it will be positive; if there’s no line, it’s negative.

Where are you in your commercialization process?

We have the technology and we’re developing the test. It will take a couple of years to go through clinical trials and approvals in the various countries. Our goal is to do all the developmental work here in Pennsylvania, and then we’ll decide where we’re going to do the manufacturing. We expect part of it to be done here in the Lehigh Valley, but we may have requirements to do it in other parts of the world. One of our goals is to create jobs in Pennsylvania.

We have hired our first several employees, who are working at the Firehouse and also on campus at Lehigh University. We also sponsor researchers at Lehigh and NYU, who are helping with some of the background work.

Have you taken advantage of any resources to help launch the company?

The Northeastern Pennsylvania Ben Franklin Technology Partners have provided funding to go to the next phase. (OraSure also started in the Ben Franklin incubator). We received grants from the National Institutes of Health, and we’re also partially funded by Originate Ventures and the NYU School of Medicine venture funding.

How will the clinical trials be conducted?

There are two main phases: The first is to collect samples, bring them back to the lab, test them with prototype devices, and show that you get accurate results. The second phase is demonstration studies, where you go to various sites, give the people who will actually perform the test your product, and have them read the instructions and use it. We’ll be testing thousands of people.

What is your biggest challenge in getting TB Biosciences off the ground?

There are few people who believed that we would have a technology capable of detecting active TB. This is like a ‘Holy Grail’ kind of project. For years, they would say in the textbooks that detecting TB this way doesn’t happen. This is something people have been searching for for a long time. We have a lot of work to do yet, but the biggest problem we have is skepticism. We’re either going to be really successful because we have an answer, or we will fail very quickly. If it works, it will impact a lot of people.

Will there be a market for your product in the United States?

There will be a market in the U.S. and the Western world for a second-generation product that’s already on the drawing board. It’s a different kind of market, because we’re looking for much earlier detection of people who are transitioning from latent to active TB. The trials here will be designed differently, and if successful will save a lot of people here from taking unnecessary drugs. It would be at a much-reduced cost from current tests. TB for us here is something the CDC keeps its eye on, because if it gets a hold in the US population, it would wreak havoc. For people with compromised immune systems, like those with HIV, TB is what they most often die of.

David C. Oxley Joins TB Biosciences Board of Directors

Bethlehem, PA – August 1, 2013 – TB Biosciences, Inc., an early stage medical diagnostics company located in Bethlehem, PA, announced that David C. Oxley has been named to TB Biosciences’ Board of Directors.

Mr. Oxley currently serves as Vice President of Emerging Markets Sales for Cytori Therapeutics (NASDAQ: CYTX), a public company engaged in the development, manufacture, and sale of medical technologies to enable the practice of regenerative medicine. Mr. Oxley’s responsibilities include establishing Cytori subsidiaries and commercial sales and distribution activities across Latin America, Africa, India, Thailand, Malaysia, Australia and New Zealand.

Prior to Cytori, Mr. Oxley served as Executive Vice President of Worldwide Sales & Marketing for the Point-of-Care Division for Trinity Biotech plc (NASDAQ: TRIB), a public company specializing in the development, manufacture and marketing of clinical diagnostic products.

Prior to his service at Trinity Biotech, Mr. Oxley served as head of government affairs at OraSure Technologies (NASDAQ: OSUR). During his service at OraSure, Mr. Oxley secured multiple bulk purchase agreements from the U.S. Department of Health and Human Services, secured World Health Organization approval of OraQuick, and secured inclusion of OraQuick on the President’s Emergency Plan for AIDS Relief bulk procurement list. Prior still, Mr. Oxley had a combined twelve years in leadership positions, including healthcare investment banking, healthcare advocacy and lobbying for a Washington, D.C. law firm, and healthcare policy work for a member of the United States House of Representatives.

In concert with his corporate experiences, Mr. Oxley served in professional and not-for-profit entities including delegate of the Private Sector Delegation to the Board of the Global Fund to Fight HIV, TB & Malaria, and outside director on the Board of the Children’s AIDS Fund.

Mr. Oxley earned a BS in History from Portland State University in Oregon and an MS in Government from Johns Hopkins University in Maryland.

“We are extremely pleased to have David join the TB Biosciences’ board,” said Sam Niedbala, Ph.D., CEO and co-founder of TB Biosciences. “As the Company works to develop a rapid point-of-care tuberculosis test that meets performance standards around the world, we are confident that David’s expertise and experience in developing and commercializing point-of-care diagnostic tests will be a valuable addition to our board,”

In addition to Mr. Oxley, TB Biosciences’ board of directors consist of Dr. Niedbala and Mike Gausling, Managing Partner with Originate Ventures, a venture capital investment firm.

About TB Biosciences

TB Biosciences, Inc. is an early stage development medical diagnostics company founded in June 2013 to develop a rapid point-of-care tuberculosis test that meets performance standards around the world. The goal of TB Biosciences is to commercialize a simple to operate and use tuberculosis test that replaces the 125 year old sputum smear test. The Company is using an array of patented peptides developed and exclusively licensed from the NYU School of Medicine. To learn more, visit www.TBBiosciences.com.

# # #

Contact: 

Sam Niedbala, CEO

TB Biosciences, Inc.

T: 800-822-9923 Ext. 1

www.TBBiosciences.com

TB Biosciences, Inc. Closes $1.5 Million in Series A Financing

Proceeds to Develop a Novel Point-of-Care Diagnostic Test for Active Tuberculosis

 Bethlehem, Pa – July 18, 2013 – Tuberculosis has been all but eradicated in the United States, yet is a massive killer worldwide, especially in developing countries. Currently, over 90 million sputum tests are conducted annually. The sputum test is less than 50% accurate and unable to diagnose many with active tuberculosis. With results no better than a coin toss, the World Health Organization (WHO) in 2011 recommended the use of ALL existing serological tests be discontinued. “The goal of TB Biosciences is to develop an accurate, easy to use, affordable, rapid point-of-care test to detect active tuberculosis and replace the unreliable sputum smear,” said Sam Niedbala, Ph.D., CEO and co-founder of TB Biosciences.

TB Biosciences, Inc., a development-stage company, announced today that it secured $1.5 million in Series A financing. The funding was led by Originate Ventures and included Ben Franklin Technology Partners of Northeastern Pennsylvania and the NYU Innovation Venture Fund. Together with recent funding from the National Institute of Health, (NIH), total new funds available for the project are in excess of $2.5 million. The funding will be used to support product development and clinical trials.

Dr. Niedbala continues, “TB Biosciences uses key peptides to detect antibodies in patients with active tuberculosis derived from the genome of the tuberculosis organism, thus offering a completely new approach to testing. Careful screening of expressed proteins has unlocked a powerful library of critical peptides, which will enable the Company to target those with active tuberculosis in children, adults and those co-infected with HIV. Preliminary performance data using samples from endemic countries has resulted in sensitivity greater than 90%. This novel approach was developed over the past 20 years at New York University School of Medicine under the scientific leadership of Suman Laal, Ph.D.”

“Sam Niedbala was a co-founder and the Chief Science Officer at OraSure Technologies (NASDAQ:OSUR) during the time that OraSure commercialized the first FDA-approved rapid, oral fluid and blood HIV test. He has extensive experience developing rapid infectious disease tests, and I believe that we have a unique opportunity under his leadership to revolutionize the way tuberculosis testing is done in the future,” stated Mike Gausling, Managing Partner at Originate Ventures. “Sam is assembling a world-class team to commercialize the technology, and Originate Ventures is excited to help TB Biosciences deliver that promise.”

“The early sensitivity and specificity data in the lab has demonstrated that TB Biosciences’ tuberculosis test is expected to meet or exceed consensus targets for sensitivity and specificity once the test is optimized. This would be a major breakthrough in tuberculosis testing and could go a long way to saving many lives each year,” says Frank Rimalovski, Executive Director of the NYU Innovation Venture Fund.

“The product development efforts for the tuberculosis test will occur in Bethlehem, Pa, and we are excited to be investors in TB Biosciences under Sam’s leadership,” stated Chad Paul, President and Chief Executive Officer of the Ben Franklin Technology Partners of Northeastern Pennsylvania. “Over the past 20 years, Sam Niedbala and Mike Gausling have created a proven track record of building a Russell 2000 company from scratch starting in our business incubator in 1988. The opportunity to invest in TB Biosciences is a terrific opportunity for us and for our global community.”

About TB Biosciences

TB Biosciences, Inc. is an early stage development medical diagnostics company founded in June 2013 to develop a rapid point-of-care tuberculosis test that meets performance standards around the world. The goal of TB Biosciences is to commercialize a simple to operate and use tuberculosis test that replaces the 125 year old sputum smear test. The Company is using an array of patented peptides developed and exclusively licensed from the NYU School of Medicine. To learn more, visit www.TBBiosciences.com.

About Originate Ventures

Originate Ventures is a venture capital investment firm, targeting early stage product and services companies located in Pennsylvania and the Mid-Atlantic region. The firm focuses on opportunities with medical devices, healthcare, consumer, information technology, Web-based and commercial products. Operating with an entrepreneurial spirit and vision, Originate’s investments range in size from $500,000 to $4,000,000. For more information, visit www.originateventures.com.

About NYU Innovation Venture Fund

The NYU Innovation Venture Fund is a $20 million seed stage venture capital fund created in 2010 to invest in startups founded by, and/or commercializing technologies developed by NYU students, faculty and researchers. For more information, visit nyu.edu/venturefund.

About the Ben Franklin Technology Partners of Northeastern Pennsylvania

The Ben Franklin Technology Partners of Northeastern Pennsylvania creates and retains highly paid, sustainable jobs by linking early-stage technology-based firms and established manufacturers with experts, universities, funding, and other resources to help them prosper through innovation. The Ben Franklin Technology Partners has returned $3.60 to the Pennsylvania treasury for every $1.00 invested in the program. It is part of an award-winning, four-center economic development initiative of the Pennsylvania Department of Community and Economic Development, and is funded by the Ben Franklin Technology Development Authority. For more information, visit www.nep.benfranklin.org.

 # # #

Contact:
R. Sam Niedbala, Ph.D.
Chief Executive Officer
TB Biosciences, Inc.
T: 800-822-9923  Ext. 1
www.TBBiosciences.com