This is the second part of a two-part series on Inovio Biomedical. Click here for the first part. SAN DIEGO ( TheStreet) -- Inovio Biomedical ( INO), a little-known biotech company, has been developing and studying an influenza vaccine that it says can protect against swine-flu -- or any flu for that matter. But the firm's history to date -- and the propensity of drug-development companies far and wide for pumping their various H1N1-related cures and tinctures -- raises doubts. In an interview with TheStreet, Inovio chief executive J. Joseph Kim attempted to allay the skepticism. For one thing, he said, the company's work on flu vaccines long predates the swine flu scare: "We didn't just jump on the bandwagon." Kim came to Inovio only in June, when the firm acquired a private vaccine-development startup called VGX Pharmaceuticals. Along with microbiologist David Weiner, Kim helped found VGX in 2000 based on a DNA vaccine formula licensed from the labs at the University of Pennsylvania, where Weiner teaches at the medical school. With that technology, VGX had been working on a flu vaccine since 2007. The big idea behind the SynCon treatment is that it would be universal. Unlike traditional vaccines that must be re-built from scratch each year to deal with new influenza strains and mutations, universal vaccines could simply be tweaked as new viruses emerge in the populace.
That's all well and good -- and, indeed, using antibodies and antigens and DNA to produce such universal vaccines has marked the cutting edge of flu research for a number of years, with one groundbreaking study released back in February (also pre-swine-flu scare). But for the time being, the U.S. government has given its blessing only to those companies most capable of providing an H1N1 vaccine the soonest, which means the traditional vaccine formulations of Big Pharma. As such, Novartis ( NVS), GlaxoSmithKline ( GSK), Sanofi-Aventis ( SNY), AztraZenica ( AZN) will help stock the nation's hospitals against the coming flu season, when H1N1 is expected to make its Northern Hemisphere comeback. "But we're not competing with the GlaxoSmithKlines and the Novartises," Kim said, arguing that Inovio's technology is poised to win big over the long term. "We're not going to have a product on the shelf this fall," he said. "But the power of our approach -- we're going to be there when these other traditional approaches fail." Nothing if not confident, Kim said Inovio will, by next summer, have obtained results from human clinical studies of SynCon used for the treatment of avian flu, followed "within a few months" by tests on human patients suffering from H1N1. Kim said Inovio has already filed an Investigational New Drug application with the FDA for the avian flu version of the vaccine. The goal, Kim said, is to bring SynCon to market under the U.S. government's emergency pandemic preparedness plan, which fast-tracks promising treatments through the clinical testing process in the event of a serious outbreak.
The company would appear to have the funding to pay for all this lab work, what with its repeated equity sales. Kim also plugged Inovio's overall vaccine expertise: Weiner with his work at Penn, Kim with his experience developing hepatitis vaccines for Merck ( MRK). Still, flu research is a relatively new pursuit for Inovio's people, whether they worked at the original company or at VGX. Before the purchase of the Kim-Weiner start-up, Inovio had no vaccines per se in its wheelhouse, only a kind of vaccine or medicine "delivery system" marketed under the brand name MedPulser, for which success has proved elusive. In 2007, before the VGX combination, the company abandoned, partly for safety concerns, a clinical trial of MedPulser as used to deliver medicine to cancer patients. Inovio had struck a deal to license the delivery technology to Wyeth ( WYE), an agreement that Inovio once claimed could yield up to $60 million in payments based on clinical study milestones. (A week after it made this deal public, Inovio announced the sale of $5.4 million worth of stock in, curiously, a subsidiary based in Singapore.) Needless to say, those milestones were not reached and Wyeth pulled out of the contract in July this year. As for VGX, the firm has largely been known as an HIV- and hepatitis-vaccine shop. Just last October, Kim said, before the sale to Inovio, VGX received a $23 million grant from the National Institute of Allergies and Infectious Diseases (part of the National Institutes of Health) to help in the development of Pennvax, the company's core HIV vaccine.
The Inovio-VGX link-up was mostly meant as a way to pair VGX's vaccine treatments with the MedPulser delivery system, a kind of injection tool designed to enhance the uptake of medicine into cells by using electricity. The company has placed its bets squarely on this combination. "We think DNA vaccines are ready for prime time," Kim enthused. "And electroporation," the term the company uses to describe the MedPulser technology, "is the key to making this happen ... It will allow us to dominate." For now, though, there's the need for more studies, more fundraising, more time, more patience, more hope. According to Kim, the combined HIV vaccine-MedPulser treatment has advanced to the first phases of human clinical trials after a batch of tests in monkeys. As for the company's flu vaccine, the next step, Kim said, is ferrets. This is the second part of a two-part series on Inovio Biomedical. Click here for the first part. -- Reported by Scott Eden in New York