The drugs have already been patented and gone through the required animal tests. If all goes as planned, the first test on humans for the Crohn’s disease drug will take place in 2013. The first human test for the breast cancer drug will follow in 2013-2014.
Peter Kiener, president, CEO, and co-founder of Zyngenia, a biotherapeutics company in Gaithersburg, is already talking to hospitals and medical centers in the United States about conducting the clinical trials, a six- to eight-year, multi-stage process before U.S. Food and Drug Administration approval can be obtained.
If they prove successful—a big “if” in the costly and competitive world of drug development—the potential payoff is immense. The market for the breast cancer drug runs into the billions of dollars; for the Crohn’s drug, in the hundreds of millions.
In 2009, Kiener, 60, who lives in Potomac, founded Zyngenia with investors David Mott, a venture capitalist with New Enterprise Associates, and Dr. Carlos Barbas III, of the Scripps Institute, whose two previous biotech ventures were bought by pharmaceutical companies.
Up till then, Kiener had worked for pharmaceutical companies, almost 20 years at Bristol-Myers Squibb, then seven years at MedImmune.
“If you want to influence disease, pharmaceutical companies are good places to be,” he says. But when the opportunity arose to head his own company, he took it and hasn’t looked back since.
“The ability to build a company from scratch is very appealing,” says Kiener, who left MedImmune as head of research and development.
That doesn’t mean it was easy, though.
At MedImmune, over 1,000 people reported to Kiener, but he wasn’t responsible for their paychecks.
“My sleepless nights,” he says of Zyngenia’s early days, “were when I started hiring people, and their livelihoods depended on me.”
Kiener is a native of Surrey, England, who came to the U.S. for his career. Tall and silver-haired, with a patient manner and the hint of a British accent still, the husband and father earned undergraduate and graduate degrees in chemistry and biochemistry, respectively. At Oxford, where he received his doctorate, he did a post-doctoral fellowship at a time when DNA sequencing was just beginning.
Fascinating as it was, its potential wasn’t yet understood.
“Scientists asked, ‘Why do we need to do this?’” he recalls. Today, DNA sequencing underlies genetic disease research.
Zyngenia is headquartered in a low-rise building called the Gaithersburg Accelerator Partnership, part of Montgomery County’s effort to grow the life-science industry. The company, with a staff of 34, occupies two spaces: a 14,000-square-foot office and, across the hall, a 9,000-square-foot lab.
At Zyngenia, the focus is on biological drugs (such as vaccines) versus chemical drugs like aspirin. Previously, most biological drugs targeted one pathway for a disease. The drugs worked, but not as well as they could, Kiener contends.
So Zyngenia combines multiple pathways in a single drug and, by doing so, makes the drug better than the different pathways might individually.
“You get additional activity,” he says. “There’s a synergy.”
Kiener gives an example: Tumor cells can be more effectively killed with a single, targeted drug than by three or four separate drugs.
“But you have to have a whole new drug. You can’t take the [same] three to four drugs and mix them all together. That’s what the whole science is about. What are the components that go into the one drug?” says Kiener, who uses zybodies—biological molecules—to develop next-generation drugs.
Zyngenia has chosen to focus on cancer and autoimmune/inflammation diseases first for several reasons: to meet medical needs, to create drugs that address those diseases and, not least, to create value for the privately held company’s investors.