Genetic Engineering & Biotechnology News

NOV1 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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8 | NOVEMBER 1, 2018 | Genetic Engineering & Biotechnology News | GENengnews.com Gail Dutton "Scrappy." That's a one-word summation of GigaGen's approach to both the business and science of biotech. "When you're a new company, you have to be scrappy and clever. When I founded GigaGen in 2011, I didn't have a big war chest of money, so I had to find a way to be competitive. That's central for survival," says Dave Johnson, Ph.D., CEO of GigaGen. Surge Workflow Performs Complete Interrogation "Competitive" means "innovative" to Dr. Johnson. That drive to innovate resulted in a proprietary workflow called Surge, which he says not only interrogates every antibody in the immune system, but does it 10 times faster than other technologies. Surge technology, he says, is what differ- entiates GigaGen from the competition. The company has a new approach to studying the immune system, which is composed of millions of different cells displaying varied receptors. Such complexity makes it difficult for researchers to delve deeply into complex interactions, Dr. Johnson suggests. Combin- ing proprietary microfluidics and genomics technologies lets GigaGen's researchers delve deeply into the immune system to find rare, high-affinity antibodies that may lead to novel immune-based therapeutics. "Without Surge, I might choose targets from the literature and interrogate them us- ing hybridomas, but that would only identify about 0.1% of the antibodies in the immune system," Dr. Johnson points out. "A lot of companies were started that way, with one drug and one target. But without a deep understanding of the immune system, most don't go anywhere." "Because we have a genomics back- ground, we can go deep into the public data- sets and analyze them differently, to discover new gene targets and then make high-quality antibodies and test them," he adds. Consequently, GigaGen has built a pipe- line of thousands of candidates with which to explore novel delivery mechanisms and bispecific antibodies. "When you paste to- gether antibodies, you need a lot of candi- dates to find two that work well together," he says. "To move the needle on cancer, you need something surprising and novel." Using Surge for immuno-oncology, the company has generated a pipeline of thousands of antibody-drug combinations against 17 targets. For immuno-oncology, he says, "we take the T cells from tumors, and rather than just culture the primary cells and perform an analysis, we make them immortal. Then we make a library to study lymphocyte and tumor interactions. In a mouse model, you wouldn't get much information, but with Surge, we can do this for millions of cells," and thereby paint a more complete picture of what happens in the body. The use of Surge also has yielded what Dr. Johnson says is the world's first recom- binant polyclonal immunoglobulin G (IgG). The product, still in development, will reduce the risk of contamination from blood-borne pathogens. Details on additional projects are under wraps until sometime in 2019. He hints, however, that "there's a lot coming out." The genomics focus that forms the foun- dation of the company is both good and bad, he admits. "My [Ph.D.] advisor would say, 'Experiment first, ask questions later.' Al- though you do need to generate a lot of data, you also need a tight focus." Otherwise, he says, a company can lose direction by having too many opportunities. It has to prioritize. Remaining true to the mission requires a lot of discipline. A Lean Approach Notwithstanding its genomics roots, GigaGen takes a lean approach to devel- opment. "We've tended not to go forward without a partner," Dr. Johnson says. That's partly because of financial necessity and partly due to good business sense. Conversations in the quest to identify the right partners help GigaGen's researchers refine their approach and more completely understand the market's needs. He sees this as a form of market validation that indicates whether certain projects actually are worthy of going forward. When a partnership is formed and a project does advance, the milestones are already aligned tightly with market needs, so resources can be used more efficiently. "Think about this on a preclinical level," Dr. Johnson continues. A company develop- ing a drug in a particular area may do 20 different things and may spend $20 million before getting feedback. "It's not always clear what the key studies will be, so many of those endeavors will be wasted if they're not exactly what the potential partner needs. Therefore, talking with those potential part- ners helps you, as a company, identify the key parts of the data package needed to move the project forward," saving time and money. "We did that in 2017 with Grifols," he recalls, "performing the early, critical experi- ments that convinced executives that we had a viable path forward." Grifols then part- nered with GigaGen to scale the project. Too Young to Succeed? The need to run lean was particularly GigaGen Exhaustively Interrogates Antibodies to Find Drug Candidates Microfluidic Dragnet Catches Most-Wanted Antibodies On Your Radar Using its Surge technology, GigaGen conducts "ultra-fast, ultra-comprehensive antibody discovery," says David S. Johnson, Ph.D., the company's founder and CEO. In this image, Dr. Johnson presents scatterplot data, generated by Surge, showing antibody-antigen binding activity. Recently, Surge enabled GigaGen to rapidly discover checkpoint inhibitor candidates against 17 immuno-oncology targets. Combining microfluidics and genomics lets GigaGen's researchers delve deeply into the immune system to find rare, high-affinity antibodies that may lead to novel immune-based therapeutics. GigaGen's massively parallel single-cell platform combines microfluidics, multiplex PCR, yeast single-chain variable fragment display, and fluorescence-activated cell sorting. In this image, GigaGen scientists are using PCR to physically link complete protein-coding sequences for massively parallel protein expression. The procedure is an alternative to nucleic acid barcoding, which computationally pairs T-cell receptor or antibody subunits.

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