Syndax Pharma Study Offers Clues that Lung Cancer Treatment Could Benefit Subset of Patients

12/10/10

Waltham, MA-based Syndax Pharmaceuticals is reporting data from a mid-stage clinical trial that indicate its lead compound might improve the effectiveness of an existing lung cancer drug, at least for a subpopulation of patients.

The company, co-founded by members of the Salk Institute for Biological Studies in La Jolla, CA, in 2005, conducted a double-blind, placebo-controlled Phase II clinical trial of its treatment in 132 patients with advanced non-small cell lung cancer. When the researchers looked at all patients in the study together, those treated with a combination treatment of its molecule, entinostat, and the blockbuster lung cancer drug erlotinib (Tarceva) did not have any longer progression-free survival those who received a combination of erlotinib and a placebo, according to the company. But in the 26 patients who had high levels of a protein called E-cadherin, the Syndax combo was associated with median survival of 9.4 months, versus 5.4 months in those patients who were on erlotinib and placebo.

Syndax’s strategy in clinical trials has been to test entinostat in combination with existing cancer drugs. The lead molecule is intended to block so-called epigenetic enzymes, essentially aiming to reprogram a patient’s tumor to be more receptive to other drugs to which the cancer might not otherwise respond. At least in the specific sub-group patients in its mid-stage clinical trial with erlotinib, the strategy appeared to work. Next year Syndax is expected to report data from a 125-patient mid-stage study of how well its drug improves treatment of advanced breast tumors in combination with the hormone therapy exemestane (Aromasin).

While the findings from the lung cancer study will need to be confirmed in further studies, they provide some hope that a fair number of lung cancer patients could benefit from Syndax’s lead compound. The company says that the E-cadherin biomarker is found in about 40 percent of patients with non-small cell lung cancer, the most common form of cancer among American adults, with more than 200,000 new cases diagnosed in the U.S. annually. Syndax plans to present the data from its lung cancer study (called ENCORE 401) today at the ASTRO 2010 Chicago Multidisciplinary Symposium in Thoracic Oncology.

It’s not uncommon nowadays for companies to develop cancer treatments for patients with specific genetic traits or whose tumors have specific characteristics. For example, New York-based drug giant Pfizer (NASDAQ:PFE) is has attracted attention in the drug-development and medical communities for its compound called crizotinib, which the company is studying as a treatment for the estimated 5 percent of lung cancer patients whose tumors express the EML4-ALK fusion gene.

Joanna Horobin, the chief executive of Syndax, said that the development of treatments targeted for specific types of tumors could benefit patients. “For the maybe 30 or 40 percent of patient with high E-cadherin, we can make Tarceva work better,” she said. “So I think that is great news for patients that there are a number of different opportunities that we can start to investigate.”

Syndax, which has raised $55 million from investors, has thus far sustained its operations primarily with funding from its venture backers and grant sources such as the National Cancer Institute. (The firm’s venture investors include the San Diego firms Avalon Ventures, Domain Associates, and Forward Ventures, as well as MPM Capital of Boston and South San Francisco, and Pappas Ventures of Durham, NC.) Horobin didn’t sound too concerned that her company has never garnered a major partnership deal with a large pharmaceutical firm to fund further development of its lead compound.

“If you put an interesting deal in front of us, we’ll be very happy to look at it,” Horobin said. “But I think we’re fortunate there is energy and excitement around the board table to move [entinostat] forward ourselves, which we’ll absolutely do.”

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