By Randall Osborne
With bombs falling on Afghanistan even as rubble is still being cleared from the terrorist attack on the World Trade Center, nobody wants to hear about agricultural biotechnology, its leaders or its investment potential.
The furor over genetically modified organisms in food looks like a silly fuss by comparison. It wasn't long ago that industry leaders were shaking their heads in chagrin over how easily and how far the GMO controversy, once limited to Europe, had spread.
But concerns lately, as everyone knows, have focused on the spread of another kind. Today, bioterrorism has made the covers of most weekly news magazines. Alarmist TV broadcasters earnestly warn viewers of home-cooked germ plagues that could wipe out the nation in no time at all scourges that apparently would be thrown together in basements by foreigners equipped with beakers, Bunsen burners and starter material ordered through the mail.
Inevitably, the coffee shop conversation is turning to biotechnology companies and their wizards, considered possible allies in the demonic plots of outsiders. Who knows? Some of these evildoers might even have infiltrated the lab-coated ranks.
Activist Jeremy Rifkin "has come out and said it's those same people who could create strains of anthrax," said D.J. Nordquist, director of communications for the Pew Initiative on Food and Biotechnology ¿ who dismissed the idea readily.
Anti-biotechnology factions "are trying to draw dotted lines between the technology behind GMO [products] and bioterrorism, but Mother Nature has done a perfectly good job" of providing deadly elements, Nordquist said.
"If you're trying to manufacture bacteria in the lab, it's pretty unstable," she added. "There are easier ways to kill people than to tamper with the corn supply."
Anyway, there's no money in bioterrorism ¿ unlike, possibly, drugs made from agricultural sources.
A think tank funded by the Pew Charitable Trusts in Washington, the initiative has issued a 105-page report titled "Harvest on the Horizon: Future Uses of Agricultural Biotechnology," which attempts to take a long view, Nordquist said, and examines prospects for those drugs along the way.
"There've been a lot of reports about insects and crops, but what we wanted to do was take a look at the whole spectrum, and really just get it all out there in the factual format," she said. "We don't advocate for or against the technology."
But investors might find something useful.
"Who knows? We did get a call from some kind of bank, but it's really intended for use in public policy," Nordquist said.
Rob Gustines, vice president of corporate development for Croptech Development Corp., which works with tobacco to develop human therapeutics, isn't so sure.
"I think their goal is to highlight the dangers of some of this technology," he said. "But if they want to push regulators to make sure the industry behaves safely, that's our goal. We probably have five to 10 years to make sure the proper [regulatory] systems are in place."
The report is expected to "enrich both the knowledge and dialogue" about agricultural biotechnology, Nordquist told BioWorld Financial Watch.
"We're trying to educate policymakers and the public, and raise questions about the regulatory system," Nordquist allowed.
Regulatory challenges are just the sort Croptech's tobacco technology are designed to meet, said Gustines, who had nothing to say about bioterrorism ¿ but plenty to say about such potential products as the firm's enzyme replacement treatment for Gaucher's disease.
Croptech has found a way to express in transgenic tobacco plants the human gene for glucocerebrosidase, which is used therapeutically to reverse the build-up of cerebroside lipids in Gaucher's disease. Genzyme Corp. already markets two products for Gaucher's: Ceredase and Cerezyme.
"We haven't reached preclinical yet," Gustines told BioWorld Financial Watch. "We're at the stage of scaling that up, but a lot is predicated on finding the right partner to move forward."
Is there a patent fight ahead?
"[Intellectual property-wise], we're pretty good, in the freedom to operate stance," Gustines said. "From the plant standpoint, it seems protected in mammalian cell culture and insect culture." Next will come in vitro modification of the Croptech product, he added, which is hoped to provide more shelter from lawsuits.
"At this point, I'm not sure [we are protected]," he said. "I believe we are."
Genzyme hasn't given any hints about its plans, if the tobacco-derived therapy moves threateningly ahead, although "we'd like to induce a response from them," Gustines said.
He noted that transgenic corn, soybeans and alfalfa are being used in transgenic work, but "tobacco has a couple of advantages."
First, it's a nonfood crop. "We're another step removed from co-mingling GMO plants that contain therapeutics in the food chain," he said.
"The other aspect is, no matter what kind of plant it is, we have a post-harvest system, so our target protein would not be present in the field," Gustines said. "We harvest it, and then produce the plant, which produces the protein. What's nice from the regulatory standpoint is that the protein is fresh, made in 24 to 48 hours. Corn would take probably twice as long."
Still, experiments with corn are being done and done to considerable effect ¿ most famously by Monsanto, Dow and DuPont. Another player is Prodigene Inc., which is "probably a drop in the bucket as far as people go, but our technology is as strong as theirs," said Elizabeth Hood, vice president of technology for Prodigene, which also works in the field of industrial enzymes but has programs in therapeutics.
"Someone finds a protein they think is important, and they contract with us to produce it in corn," Hood said. The company has a grant from the National Institutes of Health to work on an edible AIDS vaccine, and on its own also is investigating an edible hepatitis B vaccine.
"We're looking for a partner, but we've had [the hepatitis B] project going for a long time," she said.
About to enter what Hood called "human pre-Phase I clinical testing" is a product that "probably won't end up being a vaccine, but it's a protein we're using as a demonstration of the technology." The product protects against a toxin in Escherichia coli.
"We've expressed part of that in corn, and shown in an animal model that if you eat the attenuated toxin, you mount antibodies to protect against E. coli," she told BioWorld Financial Watch.
Whatever product ultimately results "would probably not be straight corn," Hood said. "It will be ground up and added to a candy bar, granola bar or a muffin."
The idea ought not to give consumers ¿ make that, patients ¿ the jitters they get about GMO foods, she added. "This is not spooky," Hood said. "You'd know about it, because you are eating it on purpose."
Nordquist insisted the report, available at the think tank's web site, www.pewagbiotech.com, is (like the organization itself), not agenda-laden.
"Our goal is not to build consumer confidence, and we're not an environmental group, either, trying to shake consumer confidence by talking about Frankenfoods," she said.
Agricultural biotechnology, Nordquist said, "is about a lot more than corn, soybeans and cotton. Those are part of the first wave, but there's a lot more in the pipeline. We're not predicting what's going to make it to market and what won't, but now is the time to look at what's on the horizon."