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they had a delivery problem, Kirn says. They were essentially injected straight into bulky tumors that show up on an X-ray, like those in the liver, lungs, or breast. But since most people get treatment when their cancer has spread throughout the body, there was only marginal benefit in shrinking the localized tumor, as the cancer was usually destined to return.
“With something that requires local or regional injection, you’ve got a niche product, not a blockbuster,” Kirn says. “To have a blockbuster, you need to be able to use it against widely metastatic cancers. It makes it really hard to finance, and hard to do partnerships.”
What Jennerex has done, with its lead candidate JX-594, is attempt to solve that delivery problem. The oncolytic virus treatment is designed to be given as an intravenous infusion, that circulates throughout the bloodstream, and can be given once every couple weeks on a visit to the doctor, Kirn says. Plus, Jennerex has designed the treatment so it can be given as a “boost” through a localized injection into the patient’s most conspicuous tumors. It’s given through a 3-D array syringe that’s supposed to make sure the virus can “de-bulk” that big tumor, while simultaneously circulating throughout the body and mopping up any cancer cells that were missed by the local injection.
The Jennerex treatment has been given to about 90 patients to date, Kirn says. The data from those small studies suggests, like with most oncolytic viruses, that it’s well-tolerated with patients usually getting flu-like symptoms in the first 24 hours after an injection but little else. That’s pretty mild by cancer drug standards. But the real proof, which Kirn acknowledges, will come when Jennerex can show its treatment helps patients actually live longer with that kind of mild side effect profile. Jennerex reported on some preliminary findings, from a study of 24 patients with liver cancer, in which three-fourths of patients on a high dose of its drug were still alive after six and 12 months, which was a higher survival rate than researchers have seen in past studies. While that finding, presented at the European Association for the Study of the Liver (EASL) is intriguing, Jennerex will have to clear a higher bar in which patients are randomly assigned to get its treatment or something else, to prove it can help people live longer.
That trial, naturally, will take a lot of time and money. Jennerex is working with its new partner, Transgene, on the design of a couple of such randomized studies that could be good enough to win approval from U.S. and European regulators. The program should start enrolling patients in the second half of 2011, Kirn says.
In the meantime, Jennerex still has plenty of work to do. It will continue working on building up its pipeline of drug candidates behind JX-594, so it doesn’t become a “one-trick pony,” Kirn says. And he will be rooting for his rivals at BioVex to score a breakthrough in their pivotal trial, which has potential to spark renewed interest in the field. If that happens, the dealmakers and Big Pharma will certainly look around for another drug like that to scarf up for their own pipelines. And then Kirn says, he’ll be bargaining from a position of strength.
“We really wanted to retain a lot more ownership and control to build the company the right way,” Kirn says. “The promise of this platform is huge, and we wanted to build it methodically and have multiple products and not become a one trick pony like VCs sometimes put pressure on companies to do.”
While you might not know it from reading the latest news in cancer drug development, Kirn insists that oncolytic viruses could someday be bigger than the targeted antibody drugs that created a $30 billion a year industry and made Roche/Genentech into the world’s biggest maker of cancer drugs.
“When this hits,” Kirn says. “It will be bigger than monoclonal antibodies.”