Intellikine has only been cooking up new drugs in the laboratory for a little more than two years, and now its first candidate is being tested in human beings.
The San Diego-based biotech dosed the first patient in a clinical trial of INK128 just before Christmas Day, says Intellikine CEO Troy Wilson. The experimental drug, a once-daily pill, will be tested at a series of doses among cancer patients with a variety of solid tumors.
The Intellikine study is one to watch, because the company raised $28.5 million last July from a prominent group of investors who are betting it will become a strong competitor among companies seeking to block a hot target for cancer, the PI3 kinase. Intellikine is developing a vast portfolio of drug candidates that can block various types (known as isoforms) of this particular kinase. But Intellikine’s lead drug is actually aiming for target that operates a little further downstream, called TORC1 and TORC2. These are enzymes that are involved in sending signals vital to cell growth, proliferation, metabolism, and energy use, Wilson says.
There are already drugs on the market—Pfizer’s temsirolimus (Torisel) and Novartis’ everolimus (Affinitor)—that work by blocking the first enzyme, TORC1, but not the second, Wilson says. While those drugs have proven themselves and won FDA approval, Intellikine and other competitors like OSI Pharmaceuticals and AstraZeneca hope that if they can also shut down TORC2, they will block one of the escape valves that enables tumors to develop resistance to the anti-cancer drug, Wilson says. OSI and AstraZeneca are already in early-phase clinical trials, racing ahead of Intellikine’s drug, Wilson says.
“We’re not first. I wish we were. But sometimes it’s a good place to be when you’re a fast follower and you can learn things,” Wilson says.
Intellikine isn’t saying much about the clinical trial protocol for INK128, and I didn’t find a listing on clinicaltrials.gov. The trial will be conducted at Sarah Cannon Research Institute in Nashville, TN; Premiere Oncology in Scottsdale, AZ; and Vall d’Hebron University Hospital in Barcelona, Spain, Wilson says. The main goal will be to evaluate safety, and researchers hope to identify a maximum tolerated dose, Wilson says.
The field of PI3 kinases is still relatively young, so I spent some time with Wilson just trying to iron out some of the confusing nomenclature people use to figure out what’s really different here.
Wilson offered his view on three different classes he sees within the field. The first is composed of drugs like one from Novartis that are “pan PI3kinase” blockers that also inhibit mTOR enzymes that operate downstream; another class of rapamycin compounds and modified analogues that specifically shut down TORC1, but not TORC2; and a third class of drugs like Intellikine’s that specifically block both TORC1 and TORC2.
Intellikine is excited about moving ahead with INK128 because it showed impressive anti-tumor activity in cell-based lab tests and animal tests, and because of its specificity, it should be better tolerated than a less-specific drug, Wilson says. That opens the possibility that INK128 could be combined more easily with other treatments in future clinical trials, he says.
“You should really only inhibit what you have to in order to kill the tumor, no more,” Wilson says.
Intellikine will have plenty of hard work ahead on steering the right course for clinical trials with INK128, answering important questions like which tumor type it is most likely to succeed against. But even to be at this stage of the game is unusual for a company of Intellikine’s vintage. The company was only founded in September 2007, and the compound was introduced into clinical trials just 18 months after it was discovered, Wilson says. That kind of efficiency is certainly a big reason why Intellikine was able to raise the capital it did last summer.
“It’s been a very rapid time for us,” Wilson says.