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Synergy Technology Promises Vaccine Booster

BT Catalyst, Sept, 1999

Imagine a biotechnology company with a platform technology, a generous corporate partnership and a one-man staff that so far receives no pay for his skills.

Is this a dream, or could such a company exist in North Carolina?

Tucked away in a small office on Davis Drive in Research Triangle Park is the startup, Synergy Vaccines Inc., founded in 1998 by a group of medical researchers and a pharmaceutical executive to commercialize a promising vaccine adjuvant.

Synergy's [SynerVax.sup.TM] technology, which uses a naturally-occurring plasma protein, is expected to boost the effectiveness of vaccines, resulting in reduced dosage requirements, side effects and vaccine treatment costs for diseases such as hepatitis, malaria and HIV. The technology may prove especially useful in developing countries, where multi-dose vaccines are hard to administer in remote areas.

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Synergy was able to skip the initial research and discovery phase of a typical biotechnology startup because this work was already completed at Duke University Medical Center by Synergy cofounders Drs. Salvatore Pizzo and George Cianciolo. The trademarked and proprietary technology was licensed to Synergy by Duke University.

"We are not looking for a product; we already have it," said Richard M. Mueller, Synergy's chairman and CEO.

The plasma protein, called alpha-2-macroglobulin, enhances the work of antigens, the vaccine component that stimulates the immune system to produce disease-fighting white blood cells. At Duke, the researchers found they could fuse the protein and the vaccine antigen by first stimulating the protein with small soluble chemicals called amines.

In federally funded research, Synergy's booster has been shown to work in vitro in both human and rodent studies, and in vivo in immunization studies involving mice and rabbits. Most recently, the technology has been demonstrated to boost by more than 100-fold the immune response of an HIV peptide vaccine candidate given to mice. In this particular study, the SynerVax booster outperformed the potent Freund's vaccine adjuvant -- the only vaccine booster that worked in prior monkey studies.

"Dr. Pizzo has been a pioneer in the field of research with alpha-2," Cianciolo said. "He has always believed that alpha-2 had additional roles other than protease control, its known function. I, as a late corner to this field, was more skeptical, but as an immunologist, I've seen responses to antigens using a totally natural adjuvant that I would have never imagined could be obtained."

The exciting potential of the booster technology spurred Mueller to convince Pizzo and Cianciolo to found Synergy. Mueller, the former CEO of Macronex Inc., saw the promise of the technology and believed that a nearly virtual company could be formed to develop it. Through development alliances, Mueller believed the company could be propelled forward without the need for venture capital -- a need that consumed Macronex and led to its eventual closure.

"There was really a lot of thought behind this [company]," he said.

In May of this year, Mueller got his wish for a development alliance. Synergy struck a deal with Becton Dickinson Technologies of Research Triangle Park to finance development of a hepatitis B vaccine using Synergy's technology. Becton Dickinson also has an option to license the resulting vaccine in Asia and Africa.

In addition to development financing, Synergy was one of the first companies to secure space in Becton Dickinson's new incubator, created from unused office and laboratory space. Synergy has access to equipment, a scientific library, conference rooms and other amenities.

Mueller works out of a modest office in the incubator and is essentially the sole employee of the company. He focuses his efforts on finding corporate-partner customers for other vaccines that would use the Synergy booster. Drs. Pizzo and Cianciolo are employed by Duke, but serve as consultants to the company. Cianciolo's role as consultant is to design and lead the development efforts to bring SynerVax's technology into clinical trials.

The market for human vaccines is substantial, totaling more than $3 billion in 1995, according to Synergy. The World Health Organization and UNICEF estimate that over the next 15 years a new generation of emerging vaccines could save the lives of eight million children annually who would otherwise die of infectious diseases.

More companies are trying to meet the demand for vaccines. In addition to the major multi-national pharmaceutical companies that dominate the market for traditional vaccines, more than 50 companies in the biotechnology sector are developing dozens of cancer vaccines alone.

On top of the human vaccines market is the potential for veterinary vaccines. Synergy estimates that the bovine mastitis vaccine alone could generate sales of $2 billion to $5 billion per year.

Mueller thinks Synergy is ready to makes its presence known in these dynamic vaccine markets.

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Synergy Technology Promises Vaccine Booster

BT Catalyst, Sept, 1999

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