The Walter Reed Army Institute of Research has exclusively licensed an immortalized liver cell line to Thai biotech firm Siam Life Science for use in preclinical drug evaluation and safety studies, according to a federal technology-transfer service that brokered the deal.
SLS, which develops and sells human cell-based technologies for drug screening and other pre-clinical applications, said it intends to work with partners to make the cell line available to the global pharmaceutical industry for use in toxicological and pharmacological testing.
The company said it is also interested in developing the technology for use in bio-artificial liver devices — an application for which SLS also has a non-exclusive license from the DoD.
“There is a worldwide shortage of functional human liver cell test systems for preclinical drug-evaluation studies,” Walter Beerheide, CEO of SLS, told CBA News in an e-mail this week. “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. Our cell line addresses this, and provides a reliable, stable, and reproducible model for toxicology studies.”
The cell line, called HC-04, was developed by SLS and the Armed Forces Research Institute of the Medical Sciences, or AFRIMS, a Bangkok-based outpost of the Walter Reed Institute.
The immortalized cells 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.
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, according to the tech-transfer service, TechLink.
Beerheide said that HC-04 is the first cell line ever to be infected with P. falciparum or P. vivax.
AFRIMS developed the cell line with SLS under a cooperative research and development agreement. Terms of that deal gave Siam Life Science the right to negotiate a license for any new invention that might arise from the research, Dan Swanson, a licensing leader at TechLink, told CBA News sister publication Biotech Transfer Week this week.
“Once the cell line was developed, [it had] different potential applications, including using [the cells to test] new drugs, but also replicating the function of the liver for artificial livers and so on,” Swanson said.
“Siam Life Science 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.
The DoD retains the right to use the technology for 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.
Though SLS had first right to negotiate a license for the technology, TechLink and the DoD had decided to work with the company because of the high incidence of liver cancer in Thailand.
“There is a worldwide shortage of functional human liver cell test systems for preclinical drug-evaluation studies.”
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 Opisthorchis viverrini, a parasite often found in a popular local raw fish dish.
In 2004, SLS became the first human cell technology company registered in Thailand, and it has a partnership with the Thailand Center of Excellence for Life Sciences. The company currently employs eight staffers in management, business development, R&D, and laboratory operations.
SLS has an office in Silom, downtown Bangkok’s principle business district, and a 300-square-foot research and production laboratory at a science center located around 15 miles outside of Bangkok.
SLS has research collaborations with academic institutions in the US, including the University of Connecticut; in Europe, including centers in Germany and Finland; and in Asia, including Thailand and Singapore.
“We have a three-pronged business approach to generating revenue: selling our products, out-licensing our technologies, and [providing] outsourcing services for pharmaceutical companies in drug evaluation/ pharmacology/toxicology,” said Beerheide.
Another market that SLS wants to participate is the development and selling of cell lines suitable for ADME/Tox testing in drug development, he added. The company is currently developing cell products with potential applications in bioartificial liver devices and cell therapeutics, including stem-cell technologies, he said.