Antigen Discovery is hoping to use a recently awarded $3 million Phase 2 Small Business Innovation Research grant to bring its protein microarrays to market.
The three-year award, announced last week, is from the National Institute of Allergy and Infectious Diseases and the National Center for Research Resources. ADI used a Phase 1 grant to optimize the microarrays, which are in a chip format and directed at both infectious diseases and biodefense targets including tuberculosis, smallpox, and Francisella tularensis, the bacteria that causes rabbit fever.
Xiaowu Liang, president, CEO, and co-founder of ADI, told ProteoMonitor that the company will use the new funding to further validate the technology, scale it up, and develop the manufacturing process.
“The grant is to commercialize what we’ve developed [during] the past few years, to set up a GMP facility here,” he said.
The company is collaborating on the grant with investigators from the Pacific Southwest Regional Center of Excellence at the University of California, Irvine.
In a statement, Huw Davies, manager of immunology at ADI and the principal investigator on the grant, said, “By using our novel protein array systems and statistical algorithms, we can rapidly discover antigen sets that will provide serological tests that discriminate between different infections, or even between different stages of the same infection.”
According to Liang, ADI’s protein microarray offering is different from others on the market because it doesn’t require protein purification and it includes services that cover the entire process from genomic DNA to microarray development.
Because the technology doesn’t require protein purification the microarrays can be manufactured much more quickly and easily, said Liang, adding that the process, because it is unbiased, can read the entire immune response across the entire proteome.
Meanwhile, ADI’s microarray business provides cloning, protein-expression, and microarray-generation and screening services. The company is able to take genes in either DNA or mRNA form and convert them into proteins on a chip in a high-throughput manner.
The approach involves a single-round PCR followed by in vivo recombination and in vitro expression and is described in a 2005 article available here.
Currently, more than 18,000 proteins from 25 different agents have been printed on chips and probed with “highly characterized” blood sera from nearly 9,000 patients, according to the company.
“The grant is to commercialize what we’ve developed [during] the past few years, to set up a GMP facility here.”
ADI has been focusing mainly on biodefense targets, Liang said, because its early funding has come from that arena, but “now we have technology ready set up … so we’re going to go after some real commercial targets, some diseases that threaten the quality of life,” including Lyme disease, autoimmune diseases, malaria, and certain sexually transmitted diseases.
The company expects to have its first prototype chip available to healthcare providers for testing within three to four months, he said.
In particular, ADI has been developing its technology for tuberculosis, a major cause of illness and death globally. According to a report released by the World Health Organization earlier this year, there were 9.2 million people worldwide newly diagnosed with tuberculosis in 2006. Around 1.7 million died from the disease during that year.
Two years ago, ADI negotiated its first R&D contract when it entered into a collaboration with the Swiss-based Foundation for Innovative New Diagnostics and New Jersey not-for-profit, the Public Health Research Institute, to identify antigens using ADI’s technology to diagnose tuberculosis.
According to Liang, the company has developed a protein chip covering 97 percent of the 4,000 genes in the tubercular proteome.
“What we’re doing is equivalent to … a puzzle with 4,000 pieces. The conventional approach is [to pick 10 or 20] pieces at a time, and then you try to guess at the whole picture,” Liang said. “Our approach is basically [putting] all 4,000 pieces together … and then you look at the whole picture, and you can see which antigens are suitable for diagnostic purposes and which antigens are potential candidates for vaccine development.”
Clearing the Way for Antigens
Founded in 2002, ADI, like many other biotech firms, sought both to capitalize on the Human Genome Project and to use information gleaned from the effort to address some long-standing issues.
“After the Human Genome Project, one of the by-products [were] many genomic sequences for microorganisms,” Liang said. “On the other hand, when you looked at diagnostics and vaccines, you still see people using 200-year-old vaccines. …We did see the discrepancy there, [the] disconnect between the vast genomic information and the actual applications or products in diagnostics, vaccines, and therapeutics.”
The bottleneck that he and company co-founder Philip Felgner saw was at the antigen stage. Depending on the disease, cloning each gene, purifying each protein, and then screening them could take a battery of scientists years to do.
Their goal was to develop technology and a workflow that could shorten the time length. Today, ADI is able to develop a protein microarray from genomic DNA in a few weeks, Liang said.
While Liang and Felgner, who now serves as company chairman, both contributed start-up financing for ADI, much of its initial funding came from government grants, in particular funding to develop technology for biodefense purposes.
ADI now generates revenues from service agreements and research and development contracts forged with industry partners — Liang declined to disclose any figures — but it still relies considerably on government grants as source of financing.
Since its inception, ADI has received more than $20 million in total government grants, Liang said.
However, the company has purposely stayed away from venture capital funding in order to retain control of the company. “When you have VC, then they have to have control of the company and its direction,” Liang said.
ADI was originally called Immport Therapeutics but was renamed Antigen Discovery earlier this year because people confused it with being an import/export business, Liang said. Based in Irvine, Calif., the privately held firm employs 12 people.
The company also does biomarker discovery work, though that is not covered by the SBIR Phase 2 grant, and is developing a hand-held microfluidic antigen detection devise, called VisiMatrix. ADI licensed the technology developed by engineers at the University of Irvine.
In order to get proper diagnosis of a disease, a set of proteins are necessary. “In that case, that really requires a test kit that accommodates that many analytes,” Liang said. “There’s a need for a simple, affordable, multiplex detection device.”
A prototype for the instrument is expected to be ready in a “few months,” Liang said.