growth driver [in breast cancer],” Horobin said, “which then allows the normal tumor suppressor activity [in cells] to work again.”
Syndax reported results over the weekend at ASCO from a Phase II, 26-patient study, in which all the women with breast cancer where given the firm’s drug entinostat in combination with an approved drug that blocks estrogen production. One patient’s breast tumor shrunk during the study and, in nine other patients, the tumors stopped growing for at least four months, according to the company.
A bigger test of the drug will be the biotech’s ongoing Phase II trial of 114 patients with breast cancer. One group in the study will take the firm’s drug in combination with a hormone therapy, Pfizer’s (NYSE:[[ticker:PFE]]) exemestane (Aromasin). Another group will take that hormone therapy and placebo, and the trial will compare how much of a difference the company’s drug makes in treating patient’s breast tumors. With results early next year, Horobin said, the firm hopes to find a drug company to partner with in order to pay for further development of the drug.
While Syndax has its headquarters in the Boston area, Horobin said, the firm’s director of scientific affairs, Peter Ordentlich, coordinates its largely virtual R&D organization from his office in San Diego. Ordentlich, a former scientist at the Salk Institute, is one of the founders of the startup. The firm was initially formed to commercialize the research of Salk biology professor Ron Evans, who has made seminal discoveries about how epigenetics plays a role in various types of cancer. Evans, who is a consultant to Syndax, is also an advisor to the Cambridge, MA-based epigenetics startup Epizyme.
Syndax’s main drug, entinostat, doesn’t actually come from Salk, but rather was licensed from Germany’s Bayer Schering Pharma in 2007. The drug is from a class of well-known drugs called histone deacetylase (HDAC) inhibitors, which take aim at the HDAC enzymes that play a role in expression of certain genes in cells. Due to their function, HDACs are called epigenetic enzymes.
The company believes that its lead drug could be used to treat other types of cancer in which the epigenetic enzymes are a factor, and the treatment has been tested so far in patients with Hodgkin’s lymphoma, a cancer of the white blood cells, a type of lung cancer, and a precursor to leukemia known as myelodysplastic syndrome.
But breast tumors, and specifically those driven by estrogen, are Syndax’s prime focus for the drug. Horobin said that a challenge in this market is to identify which patients have breast tumors that have stopped responding to hormone therapy, since that information would let her company know which patients would be most likely to benefit from the new treatment.
Keep an eye out for how Syndax’s drug performs in its latest breast cancer study. The trial could provide evidence that patients might gain a new weapon against breast tumors while helping otherwise ineffective hormone therapies to do their jobs.
