West Coast Editor
Wyeth juiced Inovio Biomedical Corp.'s bottom line with a potential $64.5 million, nonexclusive licensing deal that gives the pharma giant rights to use MedPulser electroporation delivery technology in DNA vaccines.
The arrangement - Inovio's second with a major vaccine player - brings $4.5 million up front from Wyeth Pharmaceuticals Inc., of Madison, N.J., plus annual license maintenance fees, research support, and as much as $60 million in possible milestone payments. In May 2004, Inovio (then known as Genetronics Biomedical Corp.) entered a deal with Merck & Co. Inc., of Whitehouse Station, N.J. Terms were not disclosed.
"People have been trying to develop DNA vaccines for the last 15 years," said Avtar Dhillon, president and CEO of San Diego-based Inovio. "They had terrific results in rats and rabbits," but monkeys failed to respond when scientists delivered the vaccines by conventional routes.
A quick zap provided by Inovio's MedPulser machine opens pores in cell membranes to let in therapeutic molecules, and the pores close within minutes without damage to cells.
DNA plasmid-based vaccines given this way spark higher levels of antibodies and T-cell responses, which means they could work well against such infectious diseases as HIV and hepatitis C virus.
In late October, Inovio and partner Tripep AB, of Huddinge, Sweden, reported that MedPulser-delivered ChronVac-C DNA vaccine activated a T-cell response in a mouse model that appears capable of clearing liver cells expressing HCV protein. A Phase I study of the product in healthy volunteers is set to start in the first half of 2007.
Also last month, Inovio said it had gained a $1.1 million appropriation from the U.S. Department of Defense to develop applications of electroporation-based gene delivery for vaccines against bioterrorism agents.
The firm's technology at higher voltage can attack cancer, too, and Inovio is commercializing Selective Electrochemical Tumor Ablation therapy for local treatment of solid tumors. MedPulser, the star of the show, is moving through premarketing studies for head and neck cancer and skin cancers in Europe, where the approach has won CE Mark accreditation, as well as a U.S. Phase III pivotal study for head and neck cancer, and a Phase I trial for breast tumors.
"It's really a replacement for the scalpel," Dhillon told BioWorld Today. "Instead of cutting out the tumors and the margins, you can ablate them." That's a key feature, when surgeons are cutting sections of the breast, vocal cords or tongue, for example.
The breast cancer trial started about a year ago, and is testing in up to 24 patients the safety profile of Inovio's electroporation-based SECTA therapy in conjunction (like the other trials) with the intralesionally injected anti-neoplastic agent bleomycin, which is highly toxic to cancer cells but has "relatively little activity" on healthy cells, Dhillon said.
Bleomycin cleaves DNA, sending an apoptotic signal to the tumor cells, while other cells repair themselves. Uptake of the drug is increased 2,000-fold to 3,000-fold by MedPulser. The breast-cancer study likely will have 12 patients by the end of the year - possibly enough to provide a sufficient sample - and the Phase III head and neck cancer trial is expected to reach its midpoint of 200 enrolled patients in the first quarter of next year.
Inovio took its new name in April 2005, at the same time starting a Phase I/II trial testing MedPulser against prostate cancer in the UK, as part of a collaboration with the University of Southampton. In July 2005, the firm and Vical Inc., also of San Diego, started a Phase I study of MedPulser with interleukin-2 for patients with recurrent metastatic melanoma.
Last year, Inovio started a Phase I pancreatic cancer study with SECTA, but the study was terminated to "maintain a focused and more manageable clinical program," the firm said in SEC paperwork. Tuesday, though, the spotlight fell on the Wyeth deal, likely to become the subject of buzz at the Rodman & Renshaw conference in New York, where Dhillon is presenting today.
"The wonderful things about these [DNA vaccine] deals is that we can potentially license the technology for the same targets to other partners," Dhillon said. Inovio also is seeking a partner for the MedPulser/bleomycin method against cancer.
"We're in active discussions with a number of different players," he said, adding that he expects to offer news on that front "in the next six to nine months."
As of June 30, Inovio had about $10.8 million in cash, cash equivalents and short-term investments.
Inovio's stock (AMEX:INO) closed Tuesday at $3.57, up 7 cents.