Emerging Drug Developer: Tokai Pharmaceuticals

Tokai Pharmaceuticals

Seth Harrison knows a thing or two about jump-starting a biotech company without busting the bank.

As managing general partner at Apple Tree Partners, he's had the opportunity to temporarily helm a string of start-ups he's helped finance. And he's now taken his sixth interim CEO job at Tokai Pharmaceuticals.

"Excluding myself and any consultants, there are five flesh-and-blood professionals" at Tokai, he says. Harrison plans to add about three more professionals to the team, but he's none too keen about big workforces and hefty payrolls at this stage of the game.

"With the right core management and outsourced relationships, it can be done quite nicely," says Harrison. "We hire really strong people to manage various efforts. In my start-up career, I've learned that the success or likelihood of success depends on the quality of the team. And I am very, very pleased with the quality of this team."

Among the pros at Tokai is Scott Chappel, PhD, the chief scientific officer. Chappel had earlier worked at Dyax and Serono. Taylor Burtis, the regulatory expert, has more than 25 years experience in the field, which includes a three-year stint at Wyeth.

That team has helped lure in fresh venture capital support for the Cambridge, MA-based start-up. Novartis Venture Fund joined with Apple Tree on a $22 million round in mid-May.

Tokai in-licensed its lead program from Angela Brodie's lab at the University of Maryland. Brodie won the Dorothy P. Landon-AACR Prize for Translational Cancer Research for her work developing aromatase inhibitors, a new class of breast cancer drugs.

"She's a very highly regarded medicinal chemist who works with steroid-type molecules," says Harrison. "And she's had success in the past. One drug is an anti-breast cancer drug marketed by Novartis, designed around a steroid."

Tokai has already wrapped the preclinical work on TOK-001--their androgen receptor modulator/lyase inhibitor--and laid the foundation for a Phase I/II trial. About 50 patients with castration resistant prostate cancer (CRPC) will be recruited for the early-stage study, which should get underway later this year.

"Our therapy has three independent mechanisms," says Harrison. "That's what the excitement is about. These men have no other option except toxic chemotherapy that gives them an average of 2.5 months."

Prostate cancer cells are fueled by androgens, sex hormones produced in the testes. CRPC cells become resistant to currently used therapies by finding alternative means of spurring the development of androgens. Tokai's program is aimed at shutting down the three mechanisms involved in CRPC cases: preventing the body from synthesizing new androgens, preventing the use of low-level androgens and preventing an increase in androgen receptors in CRPC cells.   

"In preclinical studies it's shown little toxicity in animals," says Harrison. "We're hoping that translates into man. And it's an oral drug, with high natural oral bioavailability. If it works, the combination is pretty powerful.

"This asset is very attractive to people interested in prostate cancer," adds Harrison. "We've been told repeatedly that this is the most interesting thing out there in the preclinical phase. The enthusiasm from the prostate cancer community combined with a clear path and the efficiency of developing this molecule, it all looked very right to focus on TOK-001.

Harrison plans to use the bulk of the $22 million to get through Phase I/II. Tokai also in-licensed a Phase II compound from Roche in osteoporosis and a preclinical program (progesterone receptor modulators for uterine fibroids) from Meiji Seika Kaisha.

But in this financing environment, Harrison is also keenly aware that an early-stage developer like Tokai has to be very selective about which programs it pursues.

"We plan to move the fibroids compound to the R&D stage and look at the financing horizon," says the CEO. "It is possibly partnerable."

Emerging Drug Developer: Tokai Pharmaceuticals
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