Biovest's custom vaccine for two types of cancer could have a sizable target market, and a sizable price tag.
Just north of Minneapolis, Biovest International is developing what it hopes is a revolutionary cancer vaccine that could extend and improve the lives of patients.
The vaccine is for people with certain types of non-Hodgkin's lymphoma, a blood cancer that affects the immune system. What makes Biovest's treatment different from others is that it customizes the vaccine for each patient so the cancer has a lower risk of returning.
"We think there is going to be tremendous demand," said company spokesman Doug Calder. "We think this represents an unmet need."
Tampa, Fla.-based Biovest plans to create hundreds of these potential cures every year inside small machines at its Coon Rapids facility. The vaccine -- called BiovaxID -- is for patients with follicular lymphoma or mantle cell lymphoma, both of which affect B-cells. About 20,000 new patients are diagnosed with these diseases each year in the United States.
While the market for the vaccine is sizable, finding a road to success could prove difficult for Biovest.
Since the vaccine is custom-made, it may cost tens of thousands of dollars if it is priced comparatively with other personalized cancer vaccines on the market.
A cautionary tale can be found in Dendreon Corp., a Seattle-based company that pioneered a personalized vaccine for prostate cancer. Because the series of vaccinations costs $93,000, the firm struggled to get enough doctors to pay such an enormous sum upfront and then wait to be reimbursed by medical insurance. The sales pace was weaker than expected, and as a result, Dendreon was forced to eliminate 500 employees. The company didn't return phone calls seeking comment.
Samuel Duffey, Biovest's president, wouldn't discuss pricing details for BiovaxID, but said he has certainly paid attention to what happened to Dendreon.
"It confirms our view that it's so important that you price your drug with full recognition of the benefit that is provided in patients," Duffey said.
Biovest is seeking approval from the U.S. Food and Drug Administration, as well as Canadian and European approval. It plans to submit its applications next year.
"We're convinced that we have a very compelling package of data," Calder said.
Patients with non-Hodgkin's lymphoma would still need chemotherapy to eliminate the cancer. But after the chemo is done, the vaccine would help prevent the cancer cells from returning.
Here's how the treatment works: Each patient's lymphoma cells have an identifying protein not present in healthy cells. This protein is unique to each patient, just like a fingerprint. Biovest receives a small sample of the patient's cancer cells through a biopsy. Then it extracts the identifying protein and multiplies it through a special machine. Biovest links the protein with a foreign shellfish protein to make the vaccine.
The body recognizes the vaccine as an invader and begins to attack and kill not only the injected vaccine, but also all lymphoma cells in the body. The body is then prepared to kill any future lymphoma cells. The treatment is given through a series of five vaccinations over a six-month period.
So far, there are only two other U.S. companies that produce personalized cancer vaccines, Dendreon and Bristol-Myers Squibb, which sells its advanced malignant melanoma vaccine for $120,000, Biovest said. The drug went on the U.S. market earlier this year.
"Typically, for personalized cancer vaccines, these are not inexpensive products," spokesman Calder said. "But what you have to look at is the quality of life, the extension of survival, and the lack of deleterious side effects."
The vaccine could be an improvement for follicular and mantle cell lymphoma patients. Fewer than 50 percent of those patients get cured through traditional chemotherapy, said Dr. Michaela Tsai of the Park Nicollet Frauenshuh Cancer Center.
Biovest said its eight-year clinical trial showed that follicular lymphoma patients who received the vaccine were disease-free for a year longer on average than those who didn't get the treatment. About five years after receiving the vaccine, patients had a 38 percent lower risk of having the cancer return.
Mantle cell lymphoma is an aggressive form of cancer; fewer than 50 percent of patients are alive five years after diagnosis. Follicular lymphoma is a slow-growing cancer, but it is usually fatal. Patients live, on average, eight to 10 years after diagnosis.
Steve Parente, a professor of health finance and insurance at the University of Minnesota's Carlson School of Management, said insurance companies might not balk at the vaccine's price because it could save money down the road.
While personalized treatments like BiovaxID could be costly, it is more expensive for insurers to continue treating recurring bouts of cancer.
"I think it's plausible the insurance companies would reimburse this," Parente said.
The state of Minnesota made great efforts to persuade Biovest to manufacture its vaccine in Coon Rapids. The company received a $1.5 million financing package.
Biovest thinks the demand for the product will exceed what its Coon Rapids facility can produce. The company creates the vaccines in machines that manufacture one patient's vaccine at one time. Each series of five vaccines can take about 2 to 3 months to create.
The company would like to build at least a 100,000-square-foot manufacturing operation and increase its workforce. The company now employs 37 in Coon Rapids.
Kathi Di Nicola, spokeswoman for the American Cancer Society, said personalized cancer vaccines are a new frontier for treatment.
"If science proves these vaccines to be effective, they represent an important step forward in cancer treatment and yet another tool in the fight for the disease," she said.
Wendy Lee • 612-673-1712