Press Release Details

WALTHAM, Mass., July 27, 2016 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on the development of novel anti-cancer therapies, announced the appointment of seven leading oncology experts to its Scientific Advisory Board (SAB).  The SAB is expected to serve as a strategic network of scientific and clinical experts to Syndax as the company progresses the development of entinostat in multiple cancer indications and initiates clinical development of SNDX-6352, a CSF-1R targeted antibody. The SAB is also expected to be an integral part of the company's strategy as it continues to assess opportunities to expand its pipeline.

"We are honored and gratified to have seven of the leading authorities in the field of cancer research agree to join our SAB," said Syndax CEO, Briggs Morrison. "We believe that the esteemed counsel of these accomplished individuals will enhance our company's ability to accelerate the development of entinostat and SNDX-6352 in multiple cancer indications, selectively expand our pipeline with the right strategic assets, and advance our mission to realize a future in which people with cancer live longer and better than ever before."

"The goal of the SAB at Syndax is to foster the development of a multi-dimensional platform to advance breakthrough therapies in diverse cancers through genomic and immune modulation," said Dr. Ronald Evans, Scientific Advisory Board Chair and Syndax co-founder.

The members of Syndax's SAB are:

• Ronald M. Evans, Ph.D. (SAB Chair and Syndax co-founder) is a Professor in the Gene Expression Laboratory at the Salk Institute for Biological Studies, a Howard Hughes Medical Institute Investigator, and holds the March of Dimes Chair in Developmental and Molecular Biology at the Salk Institute. Dr. Evans received his Ph.D. in Microbiology and Immunology and his undergraduate degree from the University of California, Los Angeles. Dr. Evans carried out his post-doctoral fellowship at Rockefeller University. Dr. Evans has been an advisor to Syndax since January 2016.
  
  Dr. Evans is known for his work on nuclear receptors, the discovery of a nuclear receptor superfamily and a unified mechanism of hormone signaling.  Hormone-receptor combinations help to control sugar, salt, calcium and fat metabolism and are primary targets in the treatment of breast cancer, prostate cancer and leukemia, osteoporosis, chronic inflammation and asthma.  As founder of Ligand Pharmaceuticals his work led to the development of Panretin^®, Targretin^® for the treatment of leukemia, as well as lasofoxifene for the treatment of osteoporosis and bazedoxifene as a hormone replacement. He was cofounder of X-Ceptor Therapeutics whose platform targeting orphan nuclear receptors for the treatment of metabolic diseases was acquired by Exelixis in 2004. He was a consultant for the development of Aragon ARN-509 and Seragon ARN-810 for prostate and breast cancer, respectively. He is the recipient of multiple awards, including the Albert Lasker Award (2004), the Wolf Prize, Israel (2012), and a Member of the National Academy of Sciences and the Institute of Medicine.

• Julie R. Brahmer, M.D., M.Sc. is Director of the Thoracic Oncology Program and Associate Professor of Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, as well as Interim Director of the Johns Hopkins Kimmel Cancer Center at Bayview. In addition, she serves as co-Principal Investigator on the Johns Hopkins' NCI National Clinical Trials Network (NCTN) Program grant and helps direct all oncology cooperative group activities on the Johns Hopkins campuses. Dr. Brahmer received her medical degree from the University of Nebraska Medical Center College of Medicine, completed her residency at the University of Utah and oncology fellowship at Johns Hopkins. Dr. Brahmer has been an advisor to Syndax since December 2015.
  
  Dr. Brahmer is committed to the research and development of immune-based therapies in the treatment of lung cancer and other cancers such as mesothelioma. She was Principal Investigator of the trials that led to the FDA approval of the first immunotherapy option in lung cancer, nivolumab. As a result of her work, she was named the March 2015 LUNGevity Hero and, in November 2015, received the Dr. Thierry Jahan "A Breath Away from the Cure" Award. Dr. Brahmer serves on the American Society of Clinical Oncology and the Eastern Cooperative Oncology Group Thoracic Committee and Cancer Prevention Steering Committee, and the Scientific Executive Committee of Free to Breathe, where she is also a founding board member. She also serves on the medical advisory board of the Lung Cancer Research Foundation and LUNGevity.

• Joseph Paul Eder, M.D. is Director of the Early Drug Development Program and Assistant Director of Experimental Therapeutics at Yale Cancer Center. Previously Dr. Eder was the Medical Science Director for AstraZeneca's Boston site and prior to that he was Clinical Director of the Dana Farber Cancer Institute General Cancer Research Center. Dr. Eder had also been the Clinical Director of the Experimental Therapeutics Program for the Dana-Farber/Harvard Cancer Center and was appointed principal clinical investigator of the Harvard UO1 Phase I program, uniting the clinical efforts of the Dana-Farber Cancer Institute, Brigham & Women's Hospital, Massachusetts General Hospital and Beth Israel Deaconess Medical Center. Dr. Eder is a graduate of Georgetown University School of Medicine, where he did a medical residency. He did fellowships in Medical Oncology at Georgetown and the Dana-Farber Cancer Institute and a fellowship in Hematology/Oncology at Beth Israel Hospital. Dr. Eder has been an advisor to Syndax since January 2016.
  
  Dr. Eder is a leader in drug development and clinical research, and has conducted studies in a variety of topics including high dose chemotherapy, the modulation/reversal of drug resistance, growth factors, vaccines, novel agents, analogue development, signal transduction pathway inhibitors, cell cycle inhibitors, and the therapeutic use of anti-angiogenesis agents. He has served on Scientific Committees of the AACR and the International Symposium on Drug Development. 

• Rachel Humphrey, M.D. is currently Chief Medical Officer at CytomX, an oncology-focused biopharmaceutical company pioneering a novel class of antibody therapeutics based on its Probody platform. Previously, Dr. Humphrey has held positions as Vice President and Head of Immuno-oncology both at Eli Lilly and at AstraZeneca and prior to that was Vice President of Product Development at Bristol-Myers Squibb (BMS). Dr. Humphrey received her medical degree from Case Western Reserve University after completing her undergraduate degree at Harvard University, trained in internal medicine at the Johns Hopkins Hospital, and began her oncology career as a fellow and staff physician at the National Cancer Institute. Dr. Humphrey has been an advisor to Syndax since November 2015.
  
  Dr. Humphrey is a leading oncology drug developer with significant achievements in the field of immunoncology and targeted therapy. At BMS, she led all aspects of the early- and late-stage clinical development, submission of global biologics license applications, and global launch of the first FDA-approved immune checkpoint inhibitor, Yervoy^® (ipilimumab). At Bayer, Dr. Humphrey supervised all aspects of the early- and late-stage clinical development of Nexavar^® (sorafenib) for the treatment of renal cell carcinoma.

• Samir Khleif, M.D. is the Director of the Georgia Cancer Center at Augusta University where he has established a comprehensive Immuno-Oncology Program that connects basic research discovery to clinical trials with highly integrated translational elements.  He is a Georgia Research Alliance Distinguished Cancer Scientist and Clinician; professor of Medicine, Biochemistry, Cancer Biology and Graduate Studies; and Director of the Immunoncology and Immunotherapeutic program.  Previously, Dr. Khleif served as Chief of the Cancer Vaccine Section at the National Cancer Institute (NCI), and Professor of Medicine at Uniformed Services University of the Health Sciences. During his tenure at NCI, Dr. Khleif was also detailed to serve for four years as the Director General and CEO of the King Hussein Cancer Center in Amman, expanding and strengthening the clinical operations and building that institution into a National Comprehensive Cancer Center of Excellence.  He also served as a Special Assistant to the FDA Commissioner from 2006-2009, where he led the FDA Critical Path for Oncology designed to restructure the oncology drug development process. He received his Medical Degree from the University of Amman in Amman, Jordon, and completed his residency at the Medical College of Ohio. Dr. Khleif has been an advisor to Syndax since December 2015.
  
  Dr. Khleif's research group focuses on the development of novel immune therapies and cancer vaccines, and rational designs for combination immune therapy, based on understanding the molecular mechanisms of the interaction between cancer and the immune system (including cancer-induced immune suppression).  He has designed and served as a Principal Investigator of more than 30 immuno-oncology clinical trials testing novel immuno-oncology approaches as single agents or in combination (e.g., vaccines, CPI or IDO inhibitors). His team designed and conducted some of the first cancer vaccine clinical trials and they are currently developing novel combination approaches to enhance anti-tumor effects.  Dr. Khleif serves on the board of the Society of Immune Therapy of Cancer and he is a member of the National Cancer Policy Forum of the National Academy of Medicine where he leads the Immunotherapy Task Force.  Dr. Khleif is the chair or member of many national committees on immuno-oncology and cancer research.  He is the recipient of many awards including the NCI Director Gold Star Award, and the Public Health Service Commendation Medal.

• Hope S. Rugo, M.D. is Professor of Medicine in the Division of Hematology and Oncology at the University of California San Francisco (UCSF) and Director of Breast Cancer and Clinical Trial Education at the UCSF Helen Diller Family Comprehensive Cancer Center. Dr. Rugo received her medical degree from the University of Pennsylvania School of Medicine after finishing an undergraduate program at Tufts University. She completed both a residency in internal medicine and fellowship in hematology and oncology at UCSF, followed by a 2-year postdoctoral fellowship in immunology at Stanford University. Dr. Rugo has been an advisor to Syndax since November 2015.  
  
  Dr. Rugo is an investigator in the national multicenter ISPY2 trial, and is the principal investigator of multiple clinical trials researching novel therapies for advanced breast cancer, immune modulation to restore chemotherapy sensitivity, and the evaluation of circulating cells as novel markers of response and resistance to therapy, neoadjuvant therapy, and supportive care. She has published many peer-reviewed papers and has given presentations on a variety of breast cancer and supportive care-related topics. Dr. Rugo is a member of the ALLIANCE Breast Core Committee and the Translational Breast Cancer Research Consortium, is the UCSF representative to the National Comprehensive Cancer Network Guidelines Committee, and serves on several committees for the American Society of Clinical Oncology. She is one of three recipients of a Komen Promise Award and received the Cancer Care Physician of the Year Award in 2010.

• Jedd D. Wolchok, M.D., Ph.D. is Chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center (MSK), an associate director of the Ludwig Center for Cancer Immunotherapy at MSK, an associate member of Ludwig Cancer Research, and holds the Lloyd J. Old/Virginia and Daniel K. Ludwig Chair in Clinical Investigation at MSK. He is director of the CRI/Ludwig Cancer Vaccine Collaborative Trials Network, and is an associate director of the CRI Scientific Advisory Council. He is also the co-director of the Swim Across America laboratory at MSK, one of the foremost immunotherapy and melanoma research groups in the country. Dr. Wolchok graduated from New York University School of Medicine and completed a residency at Memorial Sloan Kettering Cancer Center. Dr. Wolchok has been an advisor to Syndax since July 2016.
  
  Dr. Wolchok has been a leader in the pre-clinical and early clinical development of novel immunologic therapies and was instrumental in the clinical development leading to the approval of ipilimumab for advanced melanoma. He is Principal Investigator of numerous ongoing clinical trials at MSK in the area of immunotherapy. Dr. Wolchok has been recognized for his momentous career throughout the years and has received several awards including the Melanoma Research Foundation — Humanitarian Award in 2010, the Melanoma International Foundation's Doctor of the Year award in 2012, and the Live, Love, Laugh Foundation award and was named the Virginia and Daniel K. Ludwig Chair for Clinical Investigation in 2013.

About Syndax Pharmaceuticals, Inc.

Syndax is a clinical stage biopharmaceutical company focused on developing an innovative pipeline of combination therapies in multiple cancer indications. Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 clinical trial for advanced hormone receptor positive breast cancer. Concurrently, Syndax is developing entinostat, which has direct effects on both cancer cells and immune regulatory cells, and SNDX-6352 (also known as UCB 6352), an anti-CSF-1R monoclonal antibody, to potentially enhance the body's immune response on tumors that have shown sensitivity to immunotherapy. Entinostat is being evaluated as a combination therapeutic in Phase 1b/2 clinical trials with Merck & Co., Inc. for non-small cell lung cancer and melanoma, with Genentech, Inc. for TNBC, and with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer. SNDX-6352 is expected to begin clinical trials in 2016 and to be developed to treat a variety of cancers. For more information on Syndax, please visit www.syndax.com.

Syndax's Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, ability of the SAB to contribute to the success of Syndax and its programs, the timing of the clinical development of SNDX-6352 and the potential use of SNDX-6352 to treat various cancer indications. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Investor and Media Contacts

Barbara Ryan
bryan@syndax.com
(646) 690-7639