Cancer vaccine gets Netherlands approval

Frederick company Vaccinogen wins approval for production in Europe; expects U.S. launch in three years

‘‘That license is a big accomplishment,” said COO Andrew Tussing. ‘‘It paves the way for us to start booking revenues this summer. We anticipate a great deal of activity.”

OncoVax, which is created from the patient’s own tumor, is designed to prevent recurrence of colon cancer. The individualized vaccine is administered with four injections given in the six months after surgery.

The treatment has gone through five clinical trials in 30 years and has one more to go to convince the U.S. Food and Drug Administration that it is safe and effective. In its latest trial, the number of patients whose disease progressed 18 months after OncoVax treatments decreased by 64 percent.

‘‘This makes OncoVax the world’s first commercially viable vaccine for colon cancer,” CEO Michael G. Hanna Jr. said in a statement. ‘‘It is the beginning of our worldwide strategy of profitable distribution.”

Colon cancer is classified into four stages as the disease progresses. OncoVax aims to treat Stage 2; 34 percent of colon cancer patients have Stage 2, according to the American Cancer Society.

Hanna began developing the vaccine in 1972 while working on a contract for the National Cancer Institute and then ushered it through several clinical trials. After establishing Vaccinogen and acquiring OncoVax, he began talks with the FDA. The company briefly merged with another company before spinning off on its own again recently. Vaccinogen re-acquired OncoVax in February.

The company’s manufacturing facility in the Netherlands, built in 2006, can produce up to 3,500 vaccines annually, which can generate $130 million in revenues, Tussing said.

The company plans to begin its final clinical trial this summer. Roughly 560 patients will be enrolled in 32 hospitals worldwide, with half in the United States and the other half in the U.K. and the Netherlands. The trial is expected to include at least one hospital in Maryland and last about two years.

‘‘It could very well happen sooner than that,” Tussing said.

When enrollment closes, Vaccinogen will submit an interim analysis report outlining how treated patients fared, compared with non-treated patients. Then, the FDA has six months to either approve or deny the company’s application. If approved, Vaccinogen may begin commercialization in the United States immediately. The entire process could last about three years.

Dutch regulators approved the treatment faster than the FDA because they classified it as ‘‘transplant therapy” instead of a drug, Tussing said. The Netherlands’ license permits Vaccinogen to commercialize the vaccine in Switzerland and then in seven other countries in Eastern Europe: Hungary, the Czech Republic, Slovakia, Poland, Romania, Bulgaria and Slovenia.

Vaccinogen partnered with Pro Concepta in November to distribute OncoVax in major hospitals throughout Switzerland and has already secured a second distributor, Pharmacenter Hungary, for its other European target areas in the next two years. The company has no immediate plans to commercialize in the Netherlands because of the planned clinical trial there.

Vaccinogen scientists are also researching using the body’s immune system to fight two other cancers, renal carcinoma and melanoma.

Through the years

Michael Hanna Jr.’s 36-year effort to develop an individualized cancer vaccine:

1972: Hanna develops patient-specific vaccines while working on a contract for the National Cancer Institute.

1983: Hanna becomes director of the Biotechnology Research Institute in Rockville and begins conducting clinical trials for OncoVax.

1996-99: Hanna acquires rights to OncoVax and the Biotechnology Research Institute facilities. The new company, PerImmune Inc., which then merges with Intracel Corp. of Seattle. The merged companies adopt Intracel name and Hanna remains chairman.

2000: Talks begin with the FDA regarding OncoVax.

2003-06: An additional $40 million is raised with equity and debt rounds, but the company’s capital plan is unattractive to many investors. A manufacturing facility is built in Emmen, Netherlands.

2006: The FDA grants a second and pivotal phase 3b clinical trial for OncoVax, then fast-tracks it. After 30 years and more than $300 million in research and development investment, the treatment is ready for final development.

2007: Intracel approves Hanna’s proposal to form Vaccinogen, a separate company that acquires OncoVax and the manufacturing facility.

February: After securing a distributor in the Netherlands, Vaccinogen hires nine employees at the manufacturing facility. A distributor is secured for Hungary, the Czech Republic, Slovakia, Poland, Romania, Bulgaria and Slovenia.

April 25: The Dutch Ministry of Health grants Vaccinogen a manufacturing license.

Source: Vaccinogen Inc.

Colon cancer

There will be about 108,070 new cases of colon cancer and 40,740 new cases of rectal cancer in the United States this year.

Colon and rectal cancer are expected to kill about 49,960 Americans this year.

The death rate from colorectal cancer has decreased for the past 15 years, as more pre-cancerous polyps are found during screening and removed.

Four main types of treatment are surgery, radiation therapy, chemotherapy and targeted therapies with monoclonal antibodies.

About 34 percent of colon cancer patients have Stage 2 cancer, which OncoVax targets.

Surgery can cure about 70 percent of patients with Stage 2 colon cancer, while the rest relapse.

Sources: American Cancer Society, National Cancer Institute