By Keith Lawrence, Messenger-Inquirer, Owensboro, Ky.
Jul. 24–Owensboro’s Kentucky BioProcessing LLC has signed a deal that could have a huge impact on the region’s economy — if a new human papillomavirus vaccine is successful.
Louisville-based Advanced Cancer Therapeutics has signed a deal with the University of Louisville’s James Graham Brown Cancer Center to license its technology for a second-generation HPV vaccine.
And a second deal with Kentucky BioProcessing will allow ACT to use the Owensboro company’s patented GENEWARE technology to grow the vaccine inside tobacco plants and to use the Owensboro facilities for commercial production if the new product is approved for the U.S. and world markets.
If that happens, “a very, very significant capital investment would be needed” to Kentucky BioProcessing’s facilities, Hugh Haydon, KBP chairman, said Wednesday. “But the business would be there to support it.”
“This is very exciting news for KPB and the community as a whole,” said Jody Wassmer, president of the Greater Owensboro Chamber of Commerce. “It’s real proof that Owensboro-Daviess County can be a real player and job producer in the pharmaceutical world.”
HPV is a leading cause of cervical, anal and vaginal cancer, and about 20 million people are infected with the sexually transmitted disease, according to the Centers for Disease Control and Prevention.
The agency says “at least 80 percent of women will have acquired a genital HPV infection by age 50, with about 6.2 million Americans contracting a new genital HPV infection each year.”
Randall B. Riggs, ACT’s president and CEO, said 500,000 new cases of cervical cancer are reported each year. And, he said, scientists are also beginning to implicate HPV in various head, neck and lung cancers in both men and women.
“That effectively doubles the market for the vaccine, once you add men,” Haydon said.
The Food and Drug Administration estimates that it takes an average of eight years of testing to win approval for a new drug.
Riggs said it could take less time for the new vaccine because of the work already done on Gardasil, a vaccine against certain types of HPV that was created by Dr. Albert Bennet Jenson and Dr. Shin-je Ghim at the University of Louisville in 2006.
Gardasil costs about $350 for a three-dose series.
But 80 percent of the cervical cancer cases are in developing countries, Riggs said.
The new vaccine, he said, may provide broader immune protection against a greater number of the more than 200 strains of HPV at a lower cost than current vaccines.
Growing the vaccine in plants can help cut costs, Riggs said.
“Our goal is to provide a cost-effective vaccine,” he said. “We hope to open up markets in China and India.”
Those two countries have a combined population of 2.6 billion.
Haydon said some countries have a shorter window for testing new drugs than the United States. It’s possible that ACT could begin production in Owensboro for the world market before it receives FDA approval to sell the product in this country, he said.
KBP, which describes itself as “a world leader in the expression, extraction, purification and commercial scale production of proteins and other products from plants,” operates a 30,000-square-foot biomanufacturing facility with an adjacent 22,000-square-foot greenhouse at 3700 Airpark Drive.
It’s not large enough for the type of production that would be required for worldwide sales of a vaccine. “It wouldn’t happen all at once,” Haydon said. “We would have time to ramp up for production if we get there. And we hope we get there.”
ACT isn’t the company’s only customer.
Last year, two start-up companies — Mapp Biopharmaceuticals and Intrucept Biomedicine — established a local presence at KBP.
Haydon said earlier this summer that KBP is working with a dozen biotech companies on products at its bioprocessing facility. “And we’re in discussions with upwards of 20 others,” he said.
On Wednesday, Haydon said he expects at least one and maybe two more announcements this summer.
Pharmaceutical production, he said, isn’t subject to boom-and-bust cycles. The demand for medicine never slacks, Haydon said.
The intellectual property to develop the HPV vaccine, licensed to ACT through University of Louisville’s Office of Technology Transfer, is based on research by Jenson, Kenneth Palmer and their colleagues.
Palmer conducts research at the Owensboro Cancer Research Program, a joint venture between Owensboro Medical Health System and U of L at the Mitchell Memorial Cancer Center.
“We hope that the technology we are using to manufacture this vaccine will yield a product at a cost that will facilitate its use in resource-poor areas of the world where vaccines against HPV are most needed,” he said in a news release.
“Our research to date indicates that the technology we are using to produce the vaccine protein in plants will be very cost-effective.”
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