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Cancer drug trial result a surprise for Syndax

September 12, 2011

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Two months after reporting positive data from a clinical trial of its lead drug candidate for lung cancer treatment, Waltham-based Syndax Pharmaceuticals Inc. said last week that the same drug performed well in a Phase 2 breast cancer trial.

The drug, entinostat, was tested in 130 postmenopausal women with a type of the disease known as estrogen receptor-positive breast cancer.

The women received either entinostat plus exemestane (Aromasin, made by Pfizer Inc.) or exemestane plus placebo.

The combination containing Syndax’s drug nearly doubled the amount of time women survived without their disease progressing, from 2.3 months to 4.3 months. Although such “progression-free survival’’ was the primary goal, the study also found overall survival increased by nearly seven months, to 26.9 months.

Syndax is pursuing drugs designed around epigenetics - the molecular changes in cells that can activate or deactivate genes without affecting the underlying DNA. Entinostat inhibits certain enzymes that influence specific epigenetic alterations. Those epigenetic alterations are believed to drive cancer growth and drug tolerance, so blocking them should enhance cancer treatment, Syndax’s researchers believe.

The results were a pleasant surprise for Syndax’s chief executive, Joanna Horobin, who was trained as a physician before joining the drug industry 25 years ago.

“The study was not powered around overall survival, but it is still significant to see a seven-month benefit there,’’ she said.

Based on the positive results from the trial, Syndax plans to start a pivotal Phase 3 trial in early 2012.

Syndax also identified a biomarker that seems to indicate whether patients with breast cancer are responding to entinostat. The trial demonstrated that median progression-free survival rates in women with that biomarker increased to over six months.

“Rather than waiting eight weeks to take a scan to see if it’s working, we can take a blood sample before the treatment, then at day one, day eight, and day 15,’’ Horobin said. “Then we can see if the drug is impacting the target.’’

Syndax will incorporate biomarker testing into the Phase 3 trials.

If all goes well with the Phase 3 program, Horobin said, entinostat could become the first epigenetic therapy approved for patients with solid tumors.

“There hasn’t been much to improve the therapies available to breast cancer patients,’’ Horobin said. “I, as a physician, find this opportunity really exciting.’’

Arlene Weintraub

iPierian Inc., the South San Francisco, Calif., developer of stem cell technology cofounded by scientists at Harvard University, has hired a new chief executive.

Nancy Stagliano, cofounder and former chief executive of CytomX Therapeutics Inc., also in South San Francisco, has taken the top job at iPierian, while interim chief executive Peter Van Vlasselaer has moved aside to become the executive chairman.

The company has been quiet since May, when Xconomy broke the news that iPierian’s board had terminated chief executive Mike Venuti and most of the senior management team. A few weeks later, board chairman Corey Goodman resigned.

A statement from iPierian said that Van Vlasselaer has prioritized the company’s efforts over the past several months toward using its stem cell technology to help discover drugs for neurodegenerative disorders like Alzheimer’s, amyotrophic lateral sclerosis (commonly called ALS), and spinal muscular atrophy.

The company’s technology is used to coax ordinary adult cells into a stem-cell-like state in which they have the potential to differentiate into some other desired cell, like a human neuron. The cells are known as induced pluripotent stem cells.

iPierian has raised more than $50 million from some big names, including Kleiner Perkins Caufield & Byers, Highland Capital Partners, MPM Capital, Google Ventures, GlaxoSmithKline’s SR One, and Biogen Idec New Ventures.

The company was formed in 2009 by the merger of South San Francisco-based iZumi Bio with Pierian, a company cofounded by scientists at the Harvard Stem Cell Institute.

Luke Timmerman

Aura Biosciences Inc. has raised $4.5 million, bringing the Cambridge company’s total funding to $10 million in two years of operating. It develops protein cells for delivering cancer drugs directly to tumors. Aura did not name the investors in the round, but noted they are pharmaceutical industry chief executives or entrepreneurs.

This report was compiled by the editors of Xconomy, an online news website focused on the business of technology and innovation. For more New England coverage, visit