Symphogen, a 70-person biotech based in Denmark, discovers and develops biologics, in particular antibodies, that mimic the human immune system in order to treat serious illness like infectious disease and cancer.

The company recently opened an office at Princeton Forrestal Village to develop relationships and establish partnerships with key stakeholders in the United States. “The U.S. is the largest commercial market, and we thought it was important to increase the awareness of the company in the U.S.,” says Adriann Sax, chief business officer, who joined the company in August 2009.

Princeton is a “pharma Mecca” that provides easy access to cities on the Eastern seaboard and the West Coast where most biotechs and pharmaceuticals reside, says Sax. It also provides easy access to Europe and Japan, where the company has existing partnerships and relationships. “We wanted to make sure that all of the key stakeholders had a much better understanding of our technology and that we could collaborate with them as we advance our pipeline to ensure that our products will be successful when they hit the market.”

Not only does Symphogen’s new Princeton office enable the company to connect with the scientific and investor communities but also with two other important constituencies: the regulators at the Food and Drug Administration and the insurance companies that pay for drugs. “It is important to be close to the opinion leaders who are influencing the selection and choice of key treatments,” says Sax.

The normal immune response when something foreign — like a bacteria, virus, or cancer cell — enters the body is to create antibodies that find and either neutralize or destroy the invader, which has antigens on its surface. In response to antigens, the human body launches a full-scale attack, producing many kinds of antibodies that attach to specific antigens to stop the invader. Because more than one type of antibody is involved in the human immune response, it is called a “polyclonal” response.

Drugs based on antibodies provide a degree of selectivity that is not achievable with conventional small-molecule chemical drugs, but is particularly important in complex diseases like cancer. Traditional cancer drugs, for example, are called cytotoxic therapies because they use poisons to kill cancer cells. Antibodies and other biologics, however, are produced by living organisms that target active sites on the cancer cells and do not have the side effects of using poisons. The term “biologics” refers to a range of medicinal products, such as vaccines or allergenics, that are created by biological processes.

As yet, most antibodies used as drugs are monoclonal. That is, they address only one particular protein. When these monoclonal antibodies are used to treat cancer, they can shrink a tumor, says Sax, but other types of cells within the tumor may be resistant to the antibody and cause the tumor to grow again.

What distinguishes Symphogen’s products from monoclonal antibodies is that they are antibody compositions that more closely mimic the human immune system by combining several different antibodies. “By administering a composition of more than one antibody, the drug can more completely address all the different potentially resistant cells in a tumor,” says Sax. These drugs may provide more effective and safer treatments for complex diseases.

To make use of these naturally produced antibodies as drugs, they have to be genetically engineered so that the body will not reject them. In the 1970s modern biotechnological processes were developed to produce antibodies for use as therapeutics on an industrial scale. “It revolutionized medicine because it allowed us to create a virtually unlimited supply of antibodies very specific to certain diseases — in sufficient quantity for commercial use,” says Sax. “Although biologics are more expensive, they can prolong life, have been shown to improve the quality of life, and could be a cure for some patients.”

According to Datamonitor, an international business information website, in 2009 25 marketed antibodies were used to treat disease, with an additional 34 new products expected to enter the market by 2014; many more are in development. Datamonitor estimates that global sales of monoclonal antibodies, which represent the fastest growing segment of the pharmaceutical industry, will be $37 billion in 2009.

Further, the compound annual growth rate for monoclonal antibodies between 2008 and 2014 is projected to be 10.3 percent. In 2007, says Sax, Medicare alone spent $13 billion on biologics, of which antibodies are the largest category. One widely used antibody, she says, is Genentech’s Herceptin, which treats breast cancer.

The Symphogen website suggests that at present the only available treatments that resemble a polyclonal immune response are immunoglobulins, which are used, for example, in shots for rabies and hepatitis B. These are generally isolated from the blood of healthy or vaccinated donors, and in certain cases animals or donors who have recovered from a specific disease.

But because only a fraction of the antibodies are attacking a specific antigen, immunoglobulins may not be very effective, and they may also have safety issues due to the risk of disease transmission and supply shortages due to dependence on the availability of donor blood.

In Symphogen’s pipeline are 11 products in various stages of development. The lead product is in Phase II, a medicine being developed to treat idiopathic thrombocytopenic purpura, an autoimmune disease with several hundred thousand patients worldwide, and to prevent hemolytic disease in newborns.

Two drugs are being developed to treat infections, one to treat smallpox and the other, respiratory syncytial virus, a common virus that can be serious for young babies, especially to those in certain high-risk groups. Symphogen also has partnerships with Genentech and the Japanese company, Meiji Seika Kaisha, and is collaborating with them in research on infectious diseases around undisclosed targets. It also has three products in various stages of development to treat a variety of cancers.

Sax grew up in Delaware, where her mother was a second-grade schoolteacher and her father was a salesman. “My parents were both big animal lovers and really into science,” recalls Sax. “At a young age I became obsessed with animals and wanted to be a veterinarian.”

From ages 11 to 21 Sax worked for a veterinarian who encouraged her to think about a career in pharmaceuticals. Although she earned a bachelor of science in veterinary medicine from the University of Delaware in 1984, she immediately went to work in the pharmaceutical industry at Sterling Drugs, where for 11 years she was involved in sales, marketing, and marketing research. She also has an MBA from DeVry.

In 1996 Sax, left, moved to Roche Laboratories, where she launched the first antibody genetically engineered to be similar to the human immune system — for acute rejection in transplant patients. In 2000 she joined Bristol-Myers Squibb in business development for biologics in immunology and oncology. She ran the global launch of Erbitux, an antibody treatment for colorectal cancer.

In 2004 she moved to Merck for six months, but by early 2005 was head of business development and strategic planning at King Pharmaceuticals. Sax has been a big supporter of women in science and is a director on the national advisory board of the Healthcare Businesswomen’s Association.

“It is a large organization that started in New Jersey and New York because we recognized that women in our industry needed additional support, education, and development to achieve their career goals,” she says.

Sax notes that Symphogen’s CEO, Kirsten Drejer, is a woman who started as a scientist at Novo Nordisk and has been building Symphogen over the last nine years. “We see a lot of successful women, particularly in biotechs,” says Sax.

“Women are more entrepreneurial, ask more questions, and are more open and honest in their dialogues with others.” Although she admits there are still difficulties and challenges for women, Sax is surprised she has done so well. “Looking back, as a young person I never imagined I could have been able to achieve the success I have,” she says.

As for the next step for Symphogen, Sax says, “We will continue to advance our products in infectious disease and cancer through the pipeline and get them to market as soon as possible, and engage the scientific community and partners to assist us in developing products.”

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