Navigation Links
Syndax Pharmaceuticals Announces Entinostat Data from Two Lung Cancer Clinical Trials at Upcoming World Lung Conference

WALTHAM, Mass., June 27, 2011 /PRNewswire/ -- Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, today announced that data from two entinostat clinical trials both based on tumor reprogramming will be presented at the International Association for the Study of Lung Cancer's (IASLC) 14th World Conference on Lung Cancer meeting ( July 3 to 7 in Amsterdam, The Netherlands.  

"The data presentations from both lung cancer programs at the World Conference on Lung Cancer demonstrate the clinical progress we are making with entinostat as we advance toward phase three,"  said Joanna Horobin, president and chief executive officer of Syndax.  "The results add to the growing body of evidence that entinostat can maintain and restore sensitivity to standard of care treatments in distinct subpopulations of patients.  Having completed placebo-controlled phase 2 clinical trials in both lung and breast cancer, we are actively planning the final stage of development."

Entinostat and Erlotinib (Tarceva®)Targeted therapies such as epidermal growth factor receptor inhibitors (EGFRi) have greatly improved the treatment of those non small cell lung cancer (NSCLC) patients that harbor the appropriate targets. However, other patients experience less benefit due in part to epigenetic changes in the tumor which reduce the sensitivity to EGFRi such as erlotinib.  Entinostat has been shown to delay the emergence of erlotinib resistance by maintaining a sensitive tumor phenotype.(1)  In other preclinical studies entinostat was shown to synergize with certain EGFRi's to enhance gene re-expression and inhibit cancer cell growth.(2)  ENCORE-401, a double-blind, placebo-controlled phase 2 trial of erlotinib with and without entinostat in patients with advanced  NSCLC was conducted to confirm the preclinical findings.

"The patients with advanced NSCLC and elevated levels of tumor e-cadherin at the time of initial diagnosis seemed to do better when treated with erlotinib and entinostat than those treated with erlotinib alone," said Fred R. Hirsch, M.D., Ph.D., Professor of Medicine and Pathology, University of Colorado Health Sciences Center.  "Increasingly we are seeing the importance of biomarkers in predicting patient outcomes in lung cancer.  Patients with tumors with elevated e-cadherin levels represent about 40 percent of the population, demonstrating e-cadherin is a potentially relevant clinical biomarker to select patients for treatment with erlotinib plus entinostat."The following poster and oral presentation on the entinostat and erlotinib combination will be presented Wednesday, July 6 at the World Conference on Lung Cancer:Title:

Analysis of cross-over portion of ENCORE-401, a randomized, double-blind, placebo-controlled phase 2 study of erlotinib with and without entinostat, a class 1 isoform selective histone deacetylase inhibitor (HDAC) in patients with advanced non-small cell lung cancerTime:

12:15 PM – 2:15 PMSession info:

P3.220 Room:

Exhibition HallTitle:

Biomarker analysis of a randomized, double-blind, placebo-controlled phase 2 study of erlotinib with and without entinostat, a class 1 isoform selective histone deacetylase inhibitor (HDAC) in patients with advanced non-small cell lung cancer (NSCLC; ENCORE-401)Time:

2:30 PM - 4:00 PM*Session info:

Mini Oral Session, MO15.04 Room:

G104* This presentation also will be the subject of an e-poster on the same day from 12:15 to 2:15.  Entinostat and 5-Azacitidine (Vidaza®) Syndax and the National Cancer Institute (NCI) are using a dual epigenetic therapy approach to treating advanced lung cancer.   It has been shown that epigenetic gene silencing mediated by DNA methylation and histone deaceylation is a key contributor to lung carcinogenesis.  In a phase 2 clinical trial patients with recurrent, metastatic NSCLC having received at least one prior chemotherapy regimen were given 5-azacitidine (5AC) and entinostat. The trial showed that the combination of 5AC and entinostat is generally well tolerated and demonstrated major objective responses. Through biomarker analyses investigators identified a subset of patients where a greater clinical benefit was observed.  This subset consisted of patients with more methylated alleles and who experienced decreasing methylation during the first cycle of entinostat and 5AC.  This study is being sponsored by the NCI under a Cooperative Research and Development Agreement with Syndax.

"These exciting biomarker data provide new insight and a path forward to selecting patients with NSCLC for whom the entinostat and 5AC combination may be particularly beneficial," added  Dr. Horobin.  

The data from the entinostat and 5AC combination will be presented at the World Conference on Lung Cancer: Date:

Tuesday, July 5:Time:

12:15 PM - 2:00 PMSession info:


Biomarker Development for a Phase II Study of Combination Epigenetic Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC)Room:

Exhibition Hall About EntinostatSyndax's lead product entinostat has been studied in more than 600 cancer patients where objective tumor responses have been observed in both solid and hematologic malignancies. Entinostat's established safety profile as both a single agent and in combination with a number of commercially available targeted therapies differentiates it from other histone deacetylase (HDAC) inhibitors. Having shown potential in breast and lung cancer, entinostat is moving toward pivotal clinical testing. It is a novel inhibitor of class I histone deacetylases, key enzymes that alter the structure of chromatin to control gene expression. This aberrant gene expression can result in reversible, epigenetically-based drug tolerance. Designed to selectively target the HDAC isoforms most relevant to the biology of tumors, entinostat can normalize dysregulated gene expression in cancer cells.

About SyndaxSyndax Pharmaceuticals, Inc. is a Waltham, MA-based, oncology-focused pharmaceutical company. Syndax is building a portfolio of new oncology products to extend and improve the lives of patients by developing and commercializing novel cancer therapies in optimized, mechanistically driven combination regimens. Formed in 2005, the company's intellectual property is based on work from scientific founder Ronald Evans, Ph.D., recipient of the 2004 Albert Lasker Prize for Basic Medical Research, a Member of the National Academy of Sciences, a professor at the Salk Institute for Biological Studies and a Howard Hughes Medical Institute Investigator.  Syndax has worldwide rights to develop and commercialize entinostat and is backed by top-tier Venture Capital firms: Domain Associates, MPM Capital, Avalon, Pappas and Forward Ventures.  For more information please visit

  1. Sharma et al 2010 "A chromatin-mediated reversible drug-tolerant state in cancer cell subpopulations," Cell 141(1):69-80.
  2. Witta et al, 2006 "Restoring E-cadherin expression increases sensitivity to epidermal growth factor receptor inhibitors in lung cancer cell lines," Cancer Research 66(2):944-50

Contact Information
E. Blair Schoeb
Syndax Pharmaceuticals, Inc
Tel: 908-277-0386


SOURCE Syndax Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Syndax Pharmaceuticals Elects Arlene Morris to Board of Directors
2. Syndax Pharmaceuticals Announces Issuance of US Patent for Entinostat
3. Syndax Pharmaceuticals Announces Entinostat Data at 102nd Annual American Association for Cancer Research Meeting
4. Syndax Announces Start of NCI Sponsored Phase 2 Study of Entinostat in Combination in Triple Negative Breast Cancer
5. Syndax Announces Publication of Entinostat NSCLC Data in Cancer Research
6. Syndax Pharmaceuticals to Present at Biotech Showcase 2011
7. Syndax Pharmaceuticals Entinostat in Combination Shows Activity in Breast Cancer
8. Syndax Pharmaceuticals Entinostat Plus Erlotinib Improves Survival in Select NSCLC Patients
9. Syndax Pharmaceuticals Announces Issuance of UK Patent for Entinostat
10. Syndax Pharmaceuticals to Present at Sachs Biotech in Europe Investor Forum
11. Syndax Pharmaceuticals Entinostat Shows Clinical Promise in Patients with Advanced Hormone Refractory Breast Cancer
Post Your Comments:
(Date:11/26/2015)... Netherlands , November 26, 2015 ... A new combination approach blends immunotherapy with Bremachlorin-photodynamic ... A new combination approach blends immunotherapy with Bremachlorin-photodynamic therapy ... A new combination approach blends immunotherapy with Bremachlorin-photodynamic therapy ... Netherlands has found that immunotherapy can be ...
(Date:11/26/2015)... --> --> ... find optimal contrast weighting of MRI for patients with ... a research agreement with SyntheticMR in order to use SyMRI ... is possible to generate multiple contrast images from a single ... left, thus making it possible to both fine tune images ...
(Date:11/26/2015)... -- 3D bioprinting market is expected to ... report by Grand View Research Inc. Rising prevalence of chronic ... transplantation is expected to boost the market growth, as 3D ... --> 3D bioprinting market is expected to ... report by Grand View Research Inc. Rising prevalence of chronic ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... According to an article ... University of Toronto and the University of British Columbia suggested that laws requiring bicyclists ... The article explains that part of the reason for the controversial conclusion is that, ...
(Date:11/27/2015)... ... , ... The rapid speed at which Americans are aging ... is needed, especially with Alzheimer’s, dementia and other cognitive conditions becoming more prevalent. ... part of this equation: 80 percent of medical care occurs in the home, ...
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, ... to dispense prescription medications at home, so he invented the patent-pending ELECTRONIC M.D. ... dispense prescription medications. In doing so, it could help to prevent potential overdose ...
(Date:11/27/2015)... ... November 27, 2015 , ... Lizzie’s Lice Pickers just ... is offering customers 10% off of their purchase of lice treatment product. In addition, ... price. According to a company spokesperson. “Finding lice is a sure way to ruin ...
(Date:11/27/2015)... ... 2015 , ... ProSidebar: Fashion is a set of 30 kinetic ... Fasion, video editors can easily add an informative sidebar to any FCPX production. ... presets featuring self-animating drop zones, lines, bars, and text with the ease of FCPX's ...
Breaking Medicine News(10 mins):