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BIO Innovation Zone Company Snapshots: Giner, GigaGen, and Synthonics

June 11, 2015
Later this month in Philadelphia at the BIO International Convention, BIO will be partnering with the National Institutes of Health (NIH) and the National Science Foundation (NSF) to host the 2nd annual, newly-expanded BIO Innovation Zone. The Zone will feature Small Business Innovation Research (SBIR) funded early-stage biotech companies.

The SBIR/STTR program provides U.S. federal funding to small businesses engaged in research with the potential for commercialization. Each of the companies has been rigorously vetted through the SBIR/STTR review process prior to receiving the non-dilutive funding to engage in R&D that has the potential for commercialization. The NIH and NSF invest a combined $940 million annually in the programs.

Today, we spoke with Badawi Dweik, Program Manager at Giner, Inc. based in Newton, Massachusetts, David Johnson, CEO of GigaGen, Inc. in San Francisco, California, and Thomas Piccariello, President and Director of Synthonics, Inc. in Blacksburg, Virginia. These three biotechnology companies have been supported by the NIH’s SBIR program.

What is your company’s lead product or technology?

Badawi Dweik, Giner Inc.: We provide electrochemical solutions for sensors, hydrogen generators, life support oxygen generators, and a wide variety of other electrochemical devices. Electrochemical sensors for environmental, biomedical, and industrial applications have been an important segment of our business for over 15 years, with a growing record of commercial success. Electrochemical sensor systems that are under study are heavy metal sensors, carbon dioxide sensors, residual wastewater sensors, and microbial biosensors.

David Johnson, GigaGen Inc.: GigaGen’s technology platform combines microfluidics, bioinformatics, and next generation sequencing to mine B-cell repertoires for natural antibodies, revolutionizing the traditional drug discovery process. Our platform creates libraries of antibodies to express or sequence at a rate of millions per hour, eclipsing even the most efficient efforts in use today. The implication of being able to capture and analyze the complete antibody repertoire means that we can understand the immune response to disease with incredible fidelity and use its power to create lifesaving therapies.

GigaGen is conducting early research for development of the first recombinant pure IgG therapy to treat primary immune deficiencies. Primary immune deficiencies (PID) are a group of more than 200 disorders characterized by the body’s inability to properly make antibodies. Since antibodies are required to fight infection, patients with PID are susceptible to recurrent and severe infections caused by viruses and bacteria that healthy people are able to fight off naturally.

Patients with PID are currently treated with a plasma-based drug product created by collecting and pooling plasma samples from thousands of human donors. The IgG antibodies are isolated from the plasma pool and processed to remove impurities and protect against contamination. This drug is called Intravenous Immunoglobulin (IVIG) or Subcutaneous Immunoglobulin (SCIG), depending on the mode of delivery. GigaGen’s natural antibody technology enables capture and replication of the human immune system. By generating genetic immune repertoire maps from over a thousand human donors, we are working to isolate and manufacture the IgG sequences to produce the first recombinant form of IV/SCIG.

Thomas Piccariello, Synthonics Inc.: We are a biopharmaceutical company focused on the development and discovery of small molecule drugs that incorporate our novel metal coordination chemistry. Metal coordination is a molecular-level formulation technology that can control the delivery and absorption of active pharmaceutical agents.  We target approved drugs, drug candidates, and nutraceuticals whose safety, tolerability or efficacy is limited by delivery or pharmacokinetic issues.

Our lead drug candidates are a bismuth-levodopa complex (BSD) for the treatment of the symptoms of Parkinson’s disease and metal coordinated-T3 for the treatment of hypothyroidism and related metabolic disorders. It has proven very difficult to control the release of orally administered levodopa products using conventional drug delivery techniques. Even with frequent dosing, advanced Parkinson’s patients often have too much or too little of the drug in their bloodstream, resulting in significant motor complications. Similarly, the “metabolic spiking” associated with T3’s rapid absorption limits its use. We control the delivery of these drugs by binding bismuth or another metal that adheres to the gastro-intestinal lining to create a “drug depot” from which the drugs gradually release into the bloodstream.

How has the NIH SBIR program helped your company grow?

Badawi Dweik, Giner Inc.: We received funds and grants from NIH to develop these technologies.

David Johnson, GigaGen Inc.: Venture capital and big therapeutics companies require more and more data before investing or partnering with young companies. Projects that are high risk but high reward need to be "de-risked" before an investment or partnership is possible. With several SBIR grants, GigaGen has been able to build a technology platform that has led directly to venture capital investments and several revenue-generating partnerships. We are now using the platform to build our first internal drug program. Also, we participated in the I-Corps commercialization program, which helped us to focus our product development efforts by interviewing hundreds of potential customers. NIH's commitment to commercialization through SBIR is critical to the innovation pipeline, which leads to improved therapeutics, devices, and diagnostics for millions of Americans.

Thomas Piccariello, Synthonics Inc.: The NIH SBIR Grants have been instrumental in allowing us to advance one of our lead drug candidates, BSD. The data generated from the Phase I SBIR Grant helped us win additional funding through the Therapeutics Development Initiative of the Michael J. Fox Foundation. We then used that data in our application for a Phase II SBIR NIH grant. That grant helped fund the IND-enabling studies that we are now completing. In this way, Synthonics has leveraged public and private merit-based competitive funding for both the discovery and development portions of this project. The SBIR program helped our company grow by funding studies critical to our advancement and by giving credibility for our new technology.

The NIH SBIR Grant also allowed us to hire a much needed Formulation Chemist and another Research Chemist. These two new hires have allowed the company to explore the unique properties polymeric materials confer onto metal coordinated compounds. Through these efforts the company is now well positioned to develop our drug products with a higher degree of flexibility.

What are the upcoming milestones and long-term priorities for your company?

Badawi Dweik, Giner Inc.: Our commercial electrochemical devices include oxygen generators for breathable oxygen in U.S. Navy submarines, fuel cell membrane electrode assemblies (MEAs), and regenerative fuel cells for manned and unmanned vehicles in aerospace and underwater. We have licensed sensor technologies to major industrial partners, for example incorporating tens of thousands of transdermal alcohol sensors into a successful product for the law enforcement, alcohol treatment, and consumer markets. Our priority is to commercialize other electrochemical sensor systems that are under study, such as heavy metal sensors, carbon dioxide sensors, residual wastewater sensors, and microbial biosensors.

David Johnson, GigaGen Inc.: GigaGen is now conducting preclinical validation studies of the recombinant IVIG product. We are using financing from SBIR and revenue-generating partnerships to grow several batches of recombinant IVIG product, and then test the batches in mouse and in vitro models. These studies will eventually enable us to move the recombinant IVIG product into clinical studies. If the clinical studies are successful and approved by FDA, we will market the recombinant IVIG product to improve the lives of tens of thousands of PID patients worldwide. Beyond IVIG, we have several internal programs that build further upon the technology, addressing unmet clinical needs in autoimmunity and cancer.

Thomas Piccariello, Synthonics Inc.: Synthonics studies the role that metals have on the pharmacokinetics of drugs. Toward that end, we have discovered some very interesting properties that metals may confer on medicinal agents. It is Synthonics’ overarching mission to explore the importance of metal coordinated pharmaceuticals while discovering new commercially viable products and repurposing existing drugs. Out of the R&D program, several lead drug products have emerged. The company is actively pursuing acquiring proof-of-principle data in humans for the first time with both BSD and our metallo-T3 compound. The data generated from these studies will demonstrate the powerful impact metal coordination can have on pharmaceuticals and provide the needed support to further execute our business plan of licensing our drug products to pharmaceutical companies.

What do you hope to gain out of your participation at the 2015 BIO International Convention?

Badawi Dweik, Giner Inc.: Meet and connect with companies who are interested in our product, and update with other industries and products.

David Johnson, GigaGen Inc.: We are currently scheduling more than 40 meetings with various stakeholders in our innovation ecosystem. First, we have reached out to several big and small biopharmaceutical companies that may benefit from incorporating our technology into their R&D pipelines. BIO is an excellent place for such meetings, because most companies send several stakeholders from various departments. Second, we have reached out to several contract manufacturing companies (CMOs) who may be able to help us with our recombinant IVIG manufacturing. Because we do not plan to build our own manufacturing plants, careful selection of a CMO partner is absolutely critical to our organization. Third, we have scheduled meetings with the biggest IVIG producers in the world. We would like to hear what they think about our recombinant IVIG pipeline and see whether they would like to be involved somehow.

Thomas Piccariello, Synthonics Inc.: It is an honor to be included in the 2015 Innovation Zone. Our presence at BIO as partners with NIH provides us with increased exposure and legitimacy. With potentially hundreds of companies attending BIO, our mission at BIO is to inform interested parties on how MCP technology can help them with their pharmacokinetic issues or reformulation of existing drugs.

Through this increased exposure in the pharmaceutical/biotechnology industry we hope to make more companies aware of what MCP is all about while learning more about the trends in drug product development and enhancing our relationship with the NIH.

Tell us something about your company that investors might not know.

Badawi Dweik, Giner Inc.: Giner Inc. is an electrochemistry powerhouse, founded in 1973. Our mission is to bring to market innovative electrochemical components, subsystems, and systems. We provide electrochemical solutions for sensors, hydrogen generators, life support oxygen generators, and a wide variety of other electrochemical devices. Giner is a leader in the design and supply of hydrogen generation systems for applications such as: grid-level energy storage; providing fuel for fuel cell electric vehicles; and on-demand analytical gas for laboratory equipment.

David Johnson, GigaGen Inc.: We have an incredibly talented team with wide expertise, including drug commercialization, molecular genomics, and big data informatics. Our co-founder and CEO, David Johnson, has a Ph.D. in genetics from Stanford and an MBA from U.C. Berkeley. He was COO and on the founding team of the genomic diagnostics firm, Natera, which recently filed for an IPO and achieved more than $150 million in revenue in 2014. Our COO, Carter Keller, has an MBA from U.C. Berkeley and has spent over a decade running drug market planning and commercialization groups at Genentech, Achaogen, and Exelixis. Dr. Johnson and Mr. Keller met at a Berkeley alumni event. GigaGen's other co-founder is Dr. Everett Meyer, a physician-scientist and professor at Stanford University Medical Center, who specializes in immunogenetics and transplant therapies. Dr. Meyer and Dr. Johnson met in graduate school at taekwondo class, and are due a re-match!

Thomas Piccariello, Synthonics Inc.: We believe that the combination of MCP and formulation chemistry provides the kind of flexibility to solve many of the pharmacokinetic challenges that currently exist in drug product development including targeting, toxicity, efficacy, and bioavailability issues. We are currently developing this technology to expand our understanding of the power of this technology. Synthonics’ technology started as a very nascent concept and has advanced to the identification of several lead compounds with a very efficient use of resources.

Synthonics is also well positioned to help with nutraceutical products. For example, we will be soon applying and testing our MCP chemistry on the cannabinoids, cannabidiolic acid (CBDA) and tetrahydrocannabinolic acid (THCA), with the potential of significantly improving the solubility of these lipophilic compounds.