Prostate cancer has been one of the hot fields for new biotech drug development this year, and now Cambridge, MA-based Tokai Pharmaceuticals is getting into the game with a drug that it hopes will someday help men live longer and push the boundaries of science even further.
Tokai, which raised $22 million in May from Novartis Venture Funds and Apple Tree Partners, has been pretty quiet about what it is up to until today. The company is starting its first clinical trial in 50 patients to test the safety of—and look for some early signs of anti-tumor activity in— a once-daily oral pill it calls TOK-001. I heard about the concept of the drug and the company from R. Bruce Montgomery, a clinical investigator at the University of Washington, and Seth Harrison, the managing partner at Apple Tree, who’s serving as acting CEO of Tokai.
Tokai is getting into the prostate cancer field with a drug that it says is the only one of its kind to fight cancer cells simultaneously with three modes of action. The Tokai drug is building on some of the science that San Francisco-based Medivation has used to secure a partnership with Japan-based Astellas Pharma worth up to $655 million, and which prompted Johnson & Johnson to acquire Los Angeles-based Cougar Biotechnology for $894 million earlier this year. Using a completely different way of fighting tumors, by stimulating the immune system to fight cancer cells like a virus, Seattle-based Dendreon (NASDAQ: [[ticker:DNDN]]) showed it could extend lives of terminal prostate cancer patients by a median of four months time with minimal side effects, and its stock boomed nearly 10-fold this year. All of the companies have their sights set on treating a disease that kills about 30,000 men each year in the U.S.
“For the sake of people with prostate cancer, we really hope we have something,” says Tokai’s Harrison.
Scientists have known for decades that prostate cancer cells thrive on testosterone and one of its byproducts in the body, so standard treatment has long been focused on shutting down the production of tumor-fueling testosterone, Montgomery says. This treatment, known as chemical castration, usually works for about five to 10 years. But all men eventually develop resistance to the hormone-blocking therapy, Montgomery says.
Researchers have been trying to sleuth out how this can be, and it now appears that the cancer cells are clever at finding new ways to grow. Tokai is zeroing in on blocking three of the ways tumors use to grow, even when they are deprived of most of the usual testosterone they need.
One way is by blocking a receptor prostate cancer cells have for efficiently picking up