Progress in the fight against prostate cancer also is good news for Merix Bioscience.

The Durham company landed a huge $39.5 million in funding last year despite a tough financial climate because it was armed in part with positive test results from an early clinical trial for a prostate cancer vaccine. And other tests for new drugs are underway.

The prostate cancer study of 13 patients, conducted by researchers at Duke University, showed that a new way of making cancer vaccines from a patient’s own cells caused no adverse side effects and boosted the patients’ immune systems to fight cancer. Senior investigator Johannes Vieweg reports the results of the trial in the February Journal of Clinical Investigations. Results of clinical trials are often known long before the data is completely analyzed and reported in scientific journals.

Upon issuing the results, Vieweg said it was the first study with data on the safety and immunological effectiveness of the new type of vaccine. “And, while this work was done on prostate cancer patients, we believe this method may prove to work in most cancers,” he said.

Merix President and Chief Executive Officer Mark Weedon tells LocalTechWire the study involves “a key part of Merix technology. It’s key in proving its potential, and was key in helping us obtain that $40 million round of financing.”

Jeff Clark of Durham-based Aurora Funds, which, along with Intersouth Partners and Becton Dickinson’s BD Ventures, are local venture capital funds that supported the company in both its first $1.9 million funding and its most recent round, says, “We’re pleased with these initial results.”

Merix, Clark adds, “is a company with big aspirations and a management team working to pull it off.”

Weedon says the Duke study is one of five completed Phase I clinical trials designed to test the safety of various aspects of the Merix vaccine technology. “What has come through all the work to date is that we know there is a high level of safety,” he says.

The innovative experimental vaccines use a patient’s own (dentritic) white blood cells to activate anitgens, substances that the body’s killer cells recognize. Antigens trigger the immune system to attack a virus, bacteria or cancerous tumor cell.

Individually tailored vaccines

The researchers introduce RNA from the patient’s own prostrate cancer into his dentritic cells, which then create antigens specific to his tumor. When those dentritic cells are injected back into the patient, it triggers an immune response as the body’s killer cells attack the antigen-marked cancer cells.

One advantage: the method works with a tiny number of cancer cells. Cancer cells in a tumor mix with regular cells, making it difficult to obtain enough to create an immune response. In this method, RNA from a miniscule number of cancer cells can be amplified to produce the necessary amount of antigens.

On the other hand, Weedon points out that these are not mass-produced vaccines but rather each is tailored to a patient’s specific cancer.

Since receiving the hefty second round, Merix expanded its staff to 35 people and moved into state-of-the-art 20,000 square-foot laboratory facilities on Durham’s Technology Drive. When Weedon was hired last year, the company had eight employees and was housed in the small Benton Dickinson incubator in Durham.

Weedon says Merix is still doing selective recruitment for business development, marketing executives and scientific staff.

Merix is funding clinical trials at several research centers in the United States and Europe. Weedon says the company has enough cash to last through 2004, by which time it will have completed results from three to seven Phase II clinical trials.

“At that point, we’ll need another financing event to head into Phase III trials,” Weedon says.

The final Phase III trials could take several additional years, so that marketing vaccines based the technology is probably going to take until 2008 or so. “It could be earlier if the trials show remarkable effects and we’re fast-tracked. Some could be later,” Weedon says.

The U.S. Food and Drug Administration puts some experimental treatments for life-threatening diseases on a fast track to approval, reducing some of the red tape. Getting new drugs to market without fast tracking often takes 10 to 12 years.

Tests planned against many cancers

Merix recently submitted an Investigational New Drug application to the FDA to conduct a Phase I trial for a melanoma (the deadly skin cancer) vaccine. The company plans to test vaccines against a variety of cancers.

Weedon notes that Merix is on solid ground with its cancer vaccine research, but that the technology also shows promise in other areas.

Duke University Medical Center doctors Eli Gilboa, Kim Lyerly, Clay Smith and Bruce Sullenger created the technology. Merix has exclusive license from Duke University to develop vaccines based on it.

Merix also has collaboration agreements with Becton Dickinson and Silicon Valley-based Geron Corp.

Weedon notes that cancer-fighting vaccines are only the first step in finding out what the technology can do. “It also has considerable potential in treating autoimmune system diseases such as diabetes, lupus, arthritis and in helping the body not reject transplanted organs,” he says.

For more information:
www.merixbio.com