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Encouraged by Early Work on Anti-Cancer Drug, Intellikine Hires New Head for Clinical Trials

Xconomy San Diego — 

San Diego’s Intellikine will be four years old in another month, and CEO Troy Wilson tells me he’s feeling very excited about the venture-backed biotech’s progress so far in developing its pipeline of anti-cancer drugs, including its lead candidate designated INK128.

As Luke has reported previously, Intellikine’s research is focused on PI3K, shorthand for a group of kinase enzymes that help control an important cellular signaling pathway. The PI3K group is made up of four variations, or isoforms, that play slightly different roles in sending signals that help control protein synthesis, blood vessel growth, proliferation, and other cell processes.

Because PI3K enzymes are implicated in a wide variety of solid tumors and blood cancers, the PI3K pathway has become a hot target for cancer research. More than a dozen companies, including Big Pharmas like Novartis, Pfizer, and Bayer, have drug development programs targeting PI3K, as do rival biotechs like Exelixis of South San Francisco and Seattle’s Calistoga Pharmaceuticals, which was recently acquired by Gilead.

But Wilson says he likes the work Intellikine has done so far with INK128, a lead molecule designed to inhibit a key target, mTOR kinase, in a specific part of the PI3K signal pathway known as the TORC1/2 complex. The 30-employee company is planning to begin mid-stage trials of INK128 early next year, says Wilson, who calls INK128 “an exceptional drug candidate.”

Intellikine has raised a total of $62.5 million from investors, and Wilson says the company still has about $22.5 million available to move ahead to the next stage of drug development. Nevertheless, he says Intellikine also is generating strong interest among new investors. “Those discussions are ongoing,” he says, “and it’s likely the company will raise another venture round before the end of the year”.

Last year, Intellikine signed a global drug development and commercialization deal with Cambridge, MA-based Infinity Pharmaceuticals to develop small molecule drugs targeting two of the PI3K enzymes (PI3Kdelta and PI3Kgamma), a deal that eventually could generate close to $490 million for Intellikine. The company retained all rights to its programs focused on the other two P13K enzymes (PI3Kalpha and PI3Kbeta) and their related target, TORC1/2.

Yet Wilson says one reason why he likes INK128 so much is because it represents an important target in the PI3K/mTOR signaling pathway that appears to be broadly involved in a number of different cancers, including breast cancer, prostate cancer, and multiple myeloma. In addition, INK128, the company’s most advanced drug candidate, is expected to be an ideal ingredient in combination with other anti-cancer drugs.

“It’s pretty clear that cancer treatment is headed in the same direction as HIV drugs, which comprise cocktails of drugs that work in different ways,” Wilson says. “Our focus has been to develop potent and selective drug candidates that can be combined with other drugs. We’ve now done that, and we are excited to soon have three different programs targeting various points on the PI3K/mTOR pathway in human clinical trials.”

After conducting early stage testing to evaluate the safety, tolerability, and pharmacokinetics of INK128 in patients with advanced solid tumors, Wilson says Intellikine is planning to move to mid-stage trials early next year. The shift also prompted the company to hire Greg Berk, who joined Intellikine last week as chief medical officer. He was previously at Celgene, where he was senior vice president of global clinical development.

“You need to have someone on board who has clinical credentials,” Wilson says. “Greg’s been on board about 24 hours already, and he’s coming in at almost a perfect time for where we’re going.”