February 1, 2005 (Vol. 25, No. 3)
Universities and Cost Benefits Give Life Science Leg-up
The Atlanta metropolitan region ranks third nationally for the number of Fortune 500 companies headquartered there. Additionally, several medical organizations, such as the Centers for Disease Control and Prevention (CDC), the American Cancer Society, and the Arthritis Foundation are based in Atlanta.
Atlanta’s advantages are now attracting bioscience companies. These include a world-class airport, 45 colleges and universities, and low business and living costs. Commercial real estate space rents for about half the cost of Boston and San Francisco. Additionally, Atlanta ranks seventh in the country for training people with bioscience degrees, according to the Atlanta Regional Commission on Higher Education.
With 200 companies employing 13,000 workers, Georgia’s life sciences industry climbed to eighth place, according to a recent Ernst & Young report.
About three-quarters of the companies are located in Atlanta, Athens, or Augusta. Many are spin-offs of local universities, including Emory University, Georgia Institute of Technology, University of Georgia, Georgia State, Medical College of Georgia, and Morehouse Medical School.
Since 1990, the Georgia Research Alliance (www.gra.org) has worked with university researchers to find innovations with commercial potential. Under the VentureLab program funded by the Georgia Research Alliance, university incubators nurture novice companies.
At the Georgia Institute of Technology, VentureLab companies can move into wet laboratories in the Advanced Technology Development Center (ATDC). “VentureLab bridges the gap between university inventions and forming a company,” says Lee Herron, ATDC’s general manager of bioscience.
The Georgia Biomedical Partnership (www.gabio.org), the state affiliate of BIO, hosts annual Life Science Summits to promote biotechnology. About 450 people attended the first summit in 2001, and about twice as many attended the 2004 meeting.
In 2009, Atlanta is scheduled to host BIO’s Global Biotech Convention, and 25,000 people are expected. “It’s the Olympics of the biotech industry,” says Jack Spencer, former president of the Georgia Biomedical Partnership.
Overall, the Atlanta bioscience industry lags 10 to 15 years behind historical hotspots, like San Francisco, Boston, and San Diego. Although there are plenty of university incubators, facilities for growing companies are lacking, and there are no large biotechnology parks. “As companies grow, “they spread out on their own,” says Russell Allen, vp of biosciences for the Metro Atlanta Chamber of Commerce.
However, plans are under way to create a biotechnology park along Route 316, which connects Atlanta with Athens. If all goes well, Route 316 could become the “future biotech corridor,” says Allen.
Historic Company with Modern Products
Even before the biotech boom, bioscience companies headquartered in Atlanta. For instance, Serologicals dates back to 1971. The company initially isolated antibodies from plasma to counteract Rh incompatibility in newborns.
Today, Serologicals provides a broad range of specialty reagents, kits, and antibodies to researchers working in neuroscience, stem cells, and drug discovery. “We work with scientists at the benchtop and all the way up to the production of biotherapeutic products,” says David Dodd, president and CEO of Serologicals.
Through its three divisions (Chemicon International, Upstate, and Celliance), Serologicals employs 1,050 workers worldwide. The company sells 10,000 products to researchers in 50 countries. Serologicals is one of the leading suppliers of antibody kits for neuroscience researchers.
Serologicals also supplies 70% of the media used by researchers who propagate embryonic stem cells, and offers a panel of 200 kinases for drug discovery. Drug discovery customers can also contract with experts at Serologicals to screen and profile targets.
Drug Delivery and Production
Smaller and newer companies are launching innovative products. Altea Therapeutics (Tucker) is developing its PassPort system to deliver drugs and vaccines through a skin patch to eliminate painful needles.
The PassPort system “uses tiny bursts of focused thermal energy to create microchannels in the dead surface layer of skin,” explains Eric Tomlinson, Ph.D., the company’s CEO. Drugs flow easily through the microchannels, which take just two milliseconds to create.
Altea’s insulin patch is completing Phase I trials, and it will maintain constant nighttime levels of insulin in Type 2 diabetics. The company’s hydromorphone skin patch, which provides a rapid and sustained delivery of opiates to manage pain, is also in Phase I trials.
Under a CRADA with the CDC, Altea is evaluating its PassPort system for the delivery of influenza antigens to immune cells in the skin. “The skin has remarkable potential for vaccine inoculation,” says Dr. Tomlinson, and may prove better than muscle injections.
Researchers at Avigenics (Athens) are putting all their eggs into one basket. They produce interferon, human monoclonal antibodies, and other therapeutic proteins in transgenic chickens.
Genes for therapeutic proteins are introduced into chick embryos. As the birds mature, they secrete the therapeutic protein into their egg whites, where it’s easily purified with standard methods. Moreover, the proteins are glycosylated in the same patterns as they are in the human body.
Avigenics is testing its chicken-generated interferon alpha-2b in clinical trials, and it manufactures proteins for other companies. “There are no proteins that we cannot express in eggs,” says Yashwant Deo, Ph.D., president and CEO of Avigenics. These proteins include monoclonal antibodies, cytokines, and fusion proteins.
Manufacturing therapeutic proteins in eggs costs about one-tenth as much as in mammalian or bacterial cell cultures. Not only do transgenic chickens produce the therapeutic protein throughout their lifetimes, but they also pass the gene on to future generations. Moreover, the technology requires little investment in infrastructure. “Our production plant is a chicken house,” says Dr. Deo.
Improved Anti-Microbial Agents
The FDA granted Fast Track designation to two new anti-microbial treatments being developed by Inhibitex (Alpharetta). The company’s lead candidate, Veronate, is being investigated in Phase III trials to prevent hospital-acquired infections in low birth weight infants.
The other, Aurexis, is a monoclonal antibody that targets ClfA, a protein located on the surface of Staphylococcus aureus. An increasing number of drug-resistant infections are caused by S. aureus, and Aurexis is being evaluated in combination with standard antibiotics as a treatment.
Inhibitex has five drug development programs based on its proprietary MSCRAMM protein platform, which identifies surface adhesion proteins on different pathogens. “Bacteria use ClfA to attach themselves to human tissues and implanted devices,” says Russell Plumb, CFO at Inhibitex.
The company’s monoclonal antibodies bind to surface adhesion proteins to prevent pathogens from sticking and starting infections. In addition, the monoclonal antibodies recruit the immune system to destroy the microbes. Drug-resistant microbes create a growing therapeutic gap, and “we want to close that gap,” says Plumb.
Researchers at Pharmasset (Tucker) are seeking better treatments for viral infections, including HIV, hepatitis B, and hepatitis C. Founded in 1998, Pharmasset has two cytosine analogs that block reverse transcriptase in Phase II clinical trials.
The company’s Reverset is undergoing a Phase IIb trial as a treatment for AZT-resistant strains of HIV. Another analog, Racivir, is being assessed against other drug-resistant HIV strains.
In October 2004, Pharmasset partnered with Roche (Basel, Switzerland) to evaluate its PSI-6130 for treating hepatitis C. This Pharmasset compound is active against the hepatitis C virus in combination with Roche’s Pegasys (peginterferon) and Copegus (ribavirin) and could benefit patients who do not respond to current therapies.
Pharmasset’s first compounds were in-licensed from Emory University. Now newer drugs filling its pipeline are discovered in-house, illustrating “our internal expertise of nucleoside chemistry,” says Alan Roemer, vp of business development at Pharmasset.
Healthier Hearts
Atlanta-based Corautus Genetics specializes in gene transfer therapies to treat cardiovascular disease. The firm’s technology involves transferring the gene for vascular endothelial growth factor-2 (VEGF-2) to promote oxygenation and improve the growth of new blood vessels in diseased tissue.
A Phase IIb trial known as Genasis is enrolling 400 patients at 20 cardiac centers in the U.S. Defined doses of VEGF-2 will be delivered to diseased heart muscle using special catheters designed by Boston Scientific (Natick, MA). Genasis is “the largest gene therapy trial for cardiovascular disease in the U.S.,” according to Jack Callicutt, vp of finance at Corautus.
Earlier preclinical trials demonstrated that VEGF-2 gene transfer improved oxygenation and increased the growth of blood vessels in animal models.
Although Corautus is a small company with just 18 workers, they “have some of the leading cardiologists in the country as our advisors,” states Callicutt, such as Douglas Losordo, M.D., chief of cardiovascular research at St. Elizabeth’s Medical Center in Boston, who is coordinating the Genasis trial.
Healthy hearts are also the focus at AtheroGenics (Alpharetta) where researchers are targeting the underlying inflammation of atherosclerosis. A Phase III trial of the company’s lead compound, AGI-1067, has enrolled 4,000 recent heart attack patients.
The goal is “to test if AGI-1067, when added to our best medicines, can reduce the risk of future complications like another heart attack, stroke, or bypass surgery,” says Russ Medford, M.D., Ph.D., president, CEO, and co-founder of AtheroGenics in 1993.
Many risk factors for heart disease, such as smoking and high cholesterol, induce a common inflammatory response in blood vessels. AGI-1067 blocks VCAM-1, a surface adhesion molecule expressed on endothelial cells that line blood vessels.
VCAM-1 binds proteins made by white blood cells that trigger inflammation. The company’s compound AGI-1096 is in Phase I trials for the prevention of inflammation associated with organ transplant rejection.
