BY TIM BONFIELD
The Cincinnati Enquirer
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Clint "Skip" Dederick, president of Allergenics Inc., hopes to take the sting out of allergy shots.
(Glenn Hartong photo)
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From the fourth floor of a mirror-windowed office building in Blue Ash, a tiny, little-known company called Allergenics Inc. may soon make a big splash in the world of vaccines.
Imagine toddlers taking pills for immunizations, instead of getting shots and crying. Imagine ragweed sufferers taking a pill to replace twice-a-month doctor visits for allergy shots. Bigger yet, imagine an easy-to-swallow vaccine for cancer.
Until recently, many kinds of medications could not be made in capsule form because the manufacturing process itself damages the medication. Allergenics, however, has developed a process that overcomes these barriers and opens the door to a new generation of oral medications. And it's all based on research done at the University of Cincinnati Medical Center.
"A lot of applications of this technology are possible," said Clint "Skip" Dederick, president of Allergenics Inc.
Now, after six quiet years of development just across the street from the Blue Ash airport, Allergenics is taking off.
This month, the company announced that it had received the first $2.5 million of an expected $7.5 million in venture capital funding. This fall, clinical trials begin at Children's Hospital Medical Center to test a pill that might replace tetanus booster shots. In December, human testing of a grass allergy pill is to begin in California. Next summer, a ragweed pill trial is expected to involve four medical centers.
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The new technology is part of an experimental cancer vaccine going through animal testing at the National Cancer Institute, Mr. Dederick said. Other potential applications include treatments for diabetes and multiple sclerosis, anti-rejection drugs for transplant patients, even a better pill for preventing "traveler's diarrhea."
Success in any one of these areas could propel Allergenics into the major leagues of the pharmaceutical industry. In allergy-prone Cincinnati, a ragweed pill would be welcome to thousands. Oral childhood vaccines would make life easier for millions of kids. But some of the most far-reaching benefits of Allergenics' technology may be felt outside the United States, said Dr. Lindsey Wood, a former Procter & Gamble Co. executive who now serves as vice president of research and development at Allergenics.
The beauty of an oral vaccine -- as opposed to injections -- would be that the pills require no refrigeration, no sterile needles and no personnel trained in giving injections.
"Even though newborn infants cannot take pills, we could vaccinate the mothers orally and they would pass some of the immunity to their babies," Dr. Wood said.
Meanwhile in Italy, Allergenics is working with researchers testing an H. pylori vaccine, a bacteria recently discovered to be the leading cause of stomach ulcers and that has been linked with gastritis and stomach cancer.
Allergenics traces its roots to research done in 1990 by UC researcher Dr. J. Gabriel Michael and local allergy specialist Dr. Allen Litwin. They developed an "oral immunotherapy for allergy" that figured to be a better treatment for ragweed allergies than the symptom-relieving medications so many people take.
But the technology they developed has far wider uses than just ragweed, Mr. Dederick said.
Vaccines are based on "large" molecules of protein called antigens that are designed to trigger the body's immune defense system. The problem with making vaccines in pill form has been figuring how to prevent stomach acids from breaking down the protein molecules before the drug can reach the large intestine, where it can be properly absorbed.
This problem was solved years ago for "small-molecule" medications -- such as the pain reliever Contac -- by covering the tiny pills inside the capsule with an acid-resistant coating.
However, the solvent-based coatings used in those medications damage the antigens used in vaccines. So does the heat involved in applying the coating during the manufacturing process.
The UC researchers figured out a water-based coating that could resist stomach acids yet dissolve easily in the small intestine. They also figured out the right temperature and other adaptations for the capsule-making process.
Sounds simple enough. But it wasn't.
"People have been trying to do this for years," Mr. Dederick said. "They figured out how to adapt the process so it could be used for biologics (drugs synthesized from living organisms)."
With the concept part solved, the next big hurdle was finding the money for development. Actually making a pill that could help people required making deals to gain access to the vaccines to put in the new pills. Then, somebody would need to arrange for producing batches of pills and then to test those pills in the lab, in animals and finally people.
Enter Senmed Medical Ventures. Formed in 1987, Senmed is one of a handful of venture capital companies in Cincinnati and the only one focusing exclusively on biotech start-ups.
In 1992, Senmed formed Allergenics to buy the licensing rights from UC for this new "oral delivery system." Mr. Dederick is not just president of Allergenics, he's also group director of venture products for Senmed.
While Senmed's investment supported the early start-up, Mr. Dederick and his partners also worked to recruit other, even bigger investors including Venrock Associates, the venture-capital arm of the Rockefeller family; Indianapolis-based CID; and U.S. Venture Partners. Executives from those groups now sit on Allergenics' board of directors.
Despite its potentially large impact, Allergenics is a tiny company -- just four full-time employees. "We're a "virtual company,' " Mr. Dederick said.
That means the company contracts out virtually everything that involves larger numbers of employees -- such as making the pills and managing the clinical trials.
Big decisions will be made quickly should one or more of its test vaccines prove successful during clinical trials. Allergenics might sell the production rights to a big, existing pharmaceutical company. It might try to develop its own production facilities. One "home run" would provide the capital to rapidly develop other applications of the new pill-making technology -- and likely make millionaires out of the early founders and investors.
But so far, any big payoff remains pure speculation. If all goes well, Mr. Dederick said the first drug based on Allergenics' technology would be ready for market in 2001.
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