The Walter Reed Army Institute of Research, the largest biomedical research laboratory in the US Department of Defense, has exclusively licensed an immortalized liver cell line to Thai biotech firm Siam Life Science for use in preclinical drug-evaluation and -safety studies.
Siam said it intends to make the cell line available to the global pharmaceutical industry for use in toxicological and pharmacological testing, and is interested in developing the technology for use in bio-artificial liver devices, an application for which the company also has a non-exclusive license from the DoD.
The deal was announced this week by TechLink, a federally funded technology-transfer service provider that brings together the DoD and private industry for licensing and R&D partnerships.
The cell line, called HC-04, was developed at the Bangkok-based Armed Forces Research Institute of the Medical Sciences, a foreign activity of the Walter Reed Institute whose mission is to conduct basic and applied research to develop diagnostic tests, drugs, and vaccines for infectious diseases of military importance.
The immortalized line can continue to grow and divide indefinitely in vitro, but, unlike other immortalized liver cell lines, HC-04 was developed from normal human liver tissue without genetic manipulation.
In addition, the HC-04 line has been shown to retain most of its normal liver cell functions and is therefore ideal for preclinical drug evaluation and safety studies, TechLink said.
The cell line is particularly attractive as a research tool for developing drugs to treat malaria and hepatitis, and has been shown to support the in vitro development of two major malarial parasites, Plasmodium falciparum and Plasmodium vivax, TechLink said.
AFRIMS developed the cell line under a cooperative research and development agreement with Bangok-based Siam Life Sciences. Under the terms of that agreement, Siam retained the right to negotiate a license for any new invention that might arise from the research, Dan Swanson, a licensing leader at TechLink, told BTW this week.
“Once the cell line was developed, there were different potential applications including using the cells for testing new drugs, but also replicating the function of the liver for artificial livers and so on,” Swanson said.
“Siam Life Sciences was most interested and vested in the application of the technology for pharmacology and toxicology testing,” Swanson added. Financial terms of that agreement were not disclosed.
Besides the fact that Siam Life Sciences had first right to negotiate a license for the technology, TechLink and the DoD worked with the Thai company because of the high incidence of liver cancer in the country and the potential for the discovery tool to provide insights in this area.
“Most human liver cell lines currently on the market are not suitable for [pre-clinical drug-evaluation] studies because they lose much of their normal liver cell characteristics.”
According to a US Centers for Disease Control Global Health Activities Report, liver cancer is one of the leading causes of cancer deaths in Thailand, primarily because of the high rates of hepatitis B infection and infection by the liver parasite Opisthorchis viverrini, which is often transmitted through the consumption of a popular local raw fish dish.
Siam Life Sciences develops and commercializes human cell-based technologies and products primarily for screening and pre-clinical drug testing applications, but it is also developing bio-artificial liver devices, an application for which it has also taken a non-exclusive license.
A representative for Siam Life Sciences was unavailable for comment in time for this publication. However, in a statement, the company said that it intended to make the cell line widely available for drug testing.
“There is a worldwide shortage of functional human liver cell test systems for preclinical drug-evaluation studies,” Walter Beerheide, CEO of SLS, said in a statement.
“Most human liver cell lines currently on the market are not suitable for such studies because they lose much of their normal liver cell characteristics,” Beerheide added. “Our cell line addresses this and provides a reliable, stable, and reproducible model for toxicology studies.”
The DoD retains a use right for the technology in the event that it can be used in military or other applications of interest. Under the CRADA, the DoD also forfeits the right to outlicense the technology to other companies as a drug-discovery tool, but can license the cell line for other applications.
For instance, Swanson said that the cell line has also been licensed to an undisclosed US-based company for use in the development of a vaccine, likely against malaria, hepatitis, or both. Swanson also said that the cell line is still available for non-exclusive licensing outside the field of pre-clinical drug testing.
Established in 1996 at the Montana State University-Bozeman campus, TechLink was initially chartered to increase tech-transfer activities for National Aeronautics and Space Administration sites in Montana and neighboring states.
According to the federally funded entity, the DoD joined NASA in funding TechLink in 1999, and in 2003 TechLink gained permanent program status as a tech-transfer facilitator for the DoD.
“We’re a partnership intermediary,” Swanson said. “We have the lead on helping the DoD market and license its IP portfolio, which consists of between 500 and 700 patents a year. Those patents are coming out of many DoD labs and engineering centers, so it’s a pretty far-flung enterprise.”
Although the DoD has its own tech-transfer offices, which ultimately are responsible for negotiating research and license agreements, TechLink assists the department with various marketing activities and specialized assistance.
”We participated in about half of all the DoD licenses last year,” Swanson said. “So we’re generally pretty involved in the whole process of trying to use and spread best practices with the DoD laboratories.”
In fact, TechLink is one of four partnership intermediaries around the US, which also include Wexford, Penn.-based FirstLink, which helps commercialize US First Responders technology; TechMatch, based in the West Virginia High Technology Consortium Foundation in Fairmont, WV; and T2Bridge, which is based in Greenville, NC, and covers the Southeast US for the DoD.
Of these partnership intermediaries, TechLink has the lead on facilitating DoD licensing agreements, Swanson said.
TechLink has helped secure more than $64 million in R&D funding for companies in the Northwest US region from DoD and other federal agencies, and has brokered more than 480 tech-transfer partnerships between companies and federal labs including all 10 NASA centers and 67 DoD labs, according to the organization’s website.
Furthermore, TechLink was responsible for more than 30 percent of all DoD licensing nationwide since 2002, and has provided a nearly four-to-one return on investment to DoD from tech-transfer activities, the organization said.