IRX Therapeutics is a clinical-stage company developing novel immunotherapies focused on reducing the immune suppression that is seen in the cancer tumor microenvironment, restoring immune function, and activating a coordinated immune response against the tumor. The lead candidate, IRX-2, is a proprietary therapeutic containing numerous active cytokine components. Data collected to date indicates that IRX-2 acts to restore and activate multiple immune cell types, including T cells, dendritic cells, and natural killer cells to recognize and destroy tumors. Currently, IRX-2 is being studied in an ongoing phase 2b clinical trial in patients with newly diagnosed stage II, III, and IVA squamous cell carcinoma of the head and neck (SCCHN) (INSPIRE) (clinicaltrials.gov NCT02609386) and in preoperative early stage breast cancer (ESBC) (clinicaltrials.gov NCT02950259).
Mark Leuchtenberger, MBA, was appointed President and Chief Executive Officer of IRX Therapeutics in 2017. Mr. Leuchtenberger has over 20 years of experience as a senior executive in the biopharmaceutical industry where he has led companies through private financings and initial public offerings, taken products from IND through to commercialization and achieved M&A exits. Mr. Leuchtenberger was President and Chief Executive Officer and a member of the board of directors at Chiasma (NASDAQ: CHMA), Acusphere, Inc. (OTCMKTS: ACUS) and Rib-X Pharmaceuticals, Inc. (now Melinta Therapeutics, Inc.). Mr. Leuchtenberger served as President and Chief Executive Officer of Targanta Therapeutics Corporation, where he led the company’s initial public offering in 2007 and its acquisition by The Medicines Company in 2009. Mr. Leuchtenberger served as the President and Chief Executive Officer of cancer vaccine company, Therion Biologics Corporation. Prior to Therion, Mr. Leuchtenberger was a senior officer at Biogen Inc., where he led the late-stage development of Avonex and its launch in the United States and subsequently managed North American and international commercial operations as well as business development. He is a director and past chairman of the Massachusetts Biotechnology Council Board of Directors, and is a past trustee for Beth Israel Deaconess Medical Center and Chairman of the Advisory Committee for the MassDevelopment Emerging Technology Fund. He is a cofounder of Albor Biologics, Inc. and Alvos Therapeutics, Inc. He served as nonexecutive Chairman of the Board of Directors of Xenetic Biosciences, Inc. (OTCMKTS: XBIO), a biopharmaceutical company developing next-generation biologic drugs and novel oncology therapeutics, from May 2014 to April 2015. Mr. Leuchtenberger received his MBA from the Yale School of Management and his BA from Wake Forest University.
Monil Shah, PharmD, MBA, was appointed Chief Operating Officer of IRX Therapeutics in 2017. Dr, Shah has over 17 years of pharmaceutical and biotechnology industry experience in oncology drug development, including Clinical Research and Development and Medical Affairs. Dr. Shah has led and built senior level teams and also conducted business development activities, including joint collaborations and evaluation of in-licensing opportunities. Most recently, Dr. Shah was the Medical Affairs Lead for Immuno-Oncology at Bristol Myers Squibb. Dr. Shah helped start a biotech company as the Head of Clinical Operations and Development at Ventrus Biosciences. Prior to Ventrus, Dr. Shah led the solid tumor development programs and was eventually offered the opportunity to lead the clinical portfolio and strategic planning function at Celgene Corporation. He led the Oncology Development and Operations activities at Fibrogen and Novacea. Dr. Shah began his career at Novartis in the Oncology Early Development Group leading clinical trials and then continued to grow his skills in the Medical Sciences Group at Amgen. Dr. Shah received his BS and PharmD degrees from Rutgers, The State University of New Jersey and his MBA from Florida Institute of Technology.
Neil L. Berinstein, MD, FRCP(C), ABIM was appointed Chief Scientific Advisor in January 2010. Prior to joining IRX Therapeutics, Dr. Berinstein served as Assistant Vice President and Global Program Leader at Sanofi Pasteur, where he was in charge of leading the development of Sanofi’s cancer vaccines both strategically and operationally. Dr. Berinstein was responsible for interacting with international collaborators and leading researchers who were collaborating with Sanofi Pasteur either at preclinical or clinical levels. He saw to completion several multicenter phase 1 and phase 2 studies in Canada and the US in colorectal and melanoma projects.
Dr. Berinstein currently holds multiple academic and professional positions, including Professor in the Department of Medicine, University of Toronto, and Affiliate Scientist, Biological Sciences at the Odette Cancer Centre of the Sunnybrook Health Sciences Centre, Toronto. He was the Vice President of the Cancer Vaccine Consortium sponsored by the Sabin Institute and more recently is part of the executive steering committee of the Cancer Research Institute (CRI)-sponsored Cancer Vaccine Consortium. He was formerly a member and leader of the scientific review committee of the Leukemia Research Fund.
Dr. Berinstein has been the recipient of numerous grants in his research career and has published 6 book chapters, and over 100 peer-reviewed, invited or review papers to date. He received his premedical degree and Medical Doctorate from the University of Manitoba and further specialty and research training at the University of Toronto and Stanford University.
Curtis P. Robb was named Chief Financial Officer of IRX Therapeutics in July 2014. Mr. Robb joined IRX in May 2013 as SVP-Finance and Treasurer. Immediately prior to joining IRX Therapeutics, he led Robb Associates LLC, an independent financial advisory firm focusing on private equity firms investing in manufacturing companies. From 2005 through 2011, Mr. Robb served as Vice President – Business Development at Crane Co., a diversified manufacturing industrial manufacturer based in Stamford, Connecticut. While there, he completed 12 acquisitions and 12 divestitures in 4 countries in several different industries. Prior to joining Crane, Mr. Robb had over 25 years of experience in corporate finance and mergers and acquisitions as a Managing Director at HSBC Securities, CCF Charterhouse, and JP Morgan & Co., Inc., where he began his career in 1980.
Mr. Robb earned an MBA in Finance from the Wharton School at the University of Pennsylvania in 1980. He also earned a master’s degree in Economics & Politics from Cambridge University, and an AB in Mathematical Economics from Brown University.
Zygmund Roth, PhD was named Senior Vice President, Regulatory Affairs and Quality Assurance of IRX Therapeutics in September 2009. Dr. Roth joined IRX in September 2001 as Vice President, Regulatory Affairs and Quality Assurance. Between 1990 and 2001, Dr. Roth held various positions with VI Technologies, Inc. and its predecessor, the Melville Biologics Division of the New York Blood Center. Between 1994 and 2001, he held various positions including Vice President, Regulatory Affairs and Quality Assurance, and several Director-level positions for Quality Control, Quality Assurance, and Regulatory Affairs. During this period, he was responsible for the upgrading and re-licensing with the FDA of VI Technologies’ plasma fractionation facility and the licensing of a new biologic pharmaceutical: plasma treated with solvent/detergent for virus inactivation. Between 1990 and 1994, Dr. Roth managed the Quality Control laboratories at the Melville Biologics Division of the New York Blood Center. Between 1986 and 1990, he was Director of Quality Control and Quality Assurance for Kamapharm, Ltd. in Israel.
Dr. Roth earned a PhD in Pharmacology from Hebrew University in Israel, and a BSc from Trinity College.
James Egan, PhD, MBA has extensive experience in both academic and commercial drug development. Most recently Dr. Egan has served as Vice President of Business development at IRX Therapeutics. His responsibilities included every facet of drug development including fundraising from financial investors, marketing and out-licensing clinical opportunities to strategic partners, alliance management with strategic partners and external research collaborators, managing the intellectual property portfolio, overseeing internal and external research programs, and collaborating with the clinical development team to de-risk and generate proof-of-concept for products in our pipeline. Prior to joining IRX Therapeutics, Dr. Egan worked at Cold Spring Harbor Laboratories and consulted for Alliance Capital Management.
Dr. Egan received a PhD in Molecular Pharmacology from Stony Brook University and an MBA in Management and Finance from Stony Brook University.
David H. Deming was elected to the IRX Therapeutics Board of Directors in July 2013. He is Managing Director of TAG Healthcare Advisors, an affiliate of The Alberleen Group. During a career spanning 30 years in health care investment banking, Mr. Deming has served as an advisor to private and public companies on business and financial strategies and business development.
Mr. Deming’s prior professional experiences include serving as CEO of Dimensional SmartNest LLC, a customized retirement solution that Mr. Deming developed and ultimately sold to Dimensional Fund Advisors. Mr. Deming previously spent over 27 years at JP Morgan and Co., Inc., where he served as an investment banker. While there, he was Global Head of Healthcare Investment Banking for 10 years, worked in the Mergers and Acquisitions Department for eight years, and was a banker in the Financial Institutions and Oilfield Service groups early in his career. Mr. Deming holds a BA with highest honors in Economics from Hobart College, where he served as Chair of the Board of Trustees from 2006 to 2012.
Charles R. Cherington, MBA was elected to the IRX Board of Directors in September 2015. Mr. Cherington cofounded Intervale Capital in 2006 after successfully managing 2 smaller private equity firms focused on buyouts in the energy, transportation, and manufacturing sectors. He has more than 18 years of private equity experience. Before launching his first fund, Mr. Cherington spent 3 years as a vice president at the Vietnam Fund, a British private equity fund. He also worked for Credit Suisse in New York.
Mr. Cherington received an MBA, with honors, from the University of Chicago and a BA in History from Wesleyan University.
George P. Denny III was elected to the IRX Therapeutics Board of Directors in September 2013. He is a founding partner at Halpern, Denny & Co., a private equity investment group based in Boston, which he co-founded in 1991.
Prior to forming Halpern, Denny & Co., Mr. Denny was the Managing Director for Bain Holdings, an investment partnership formed by Bain & Company. For many years, Mr. Denny was a partner of Bain & Company and headed its West Coast and Japanese operations. Mr. Denny has served on the national board of directors of the Trust for Public Land since April 1990 and as its Chairman since October 2003. He is also the Chairman of Denny Land & Cattle Company, which produces wild rice and timothy hay, and runs cattle operations in California. He is a partner at Boston Common Press, the publisher of Cook’s Illustrated magazine and America’s Test Kitchen cookbooks. Mr. Denny serves on the Board of Directors of The Natural Resource Defense Council Action Fund and previously served on the Board of the Maine Chapter of The Nature Conservancy. Mr. Denny is a graduate of Harvard University and received his MBA as a Baker Scholar from the Harvard Business School.
John W. Hadden II, MBA, has served as a Director since 1999. Mr. Hadden was Chief Executive Officer of IRX Therapeutics from January 2007 to March 2017. Between 2004 and 2007, Mr. Hadden was IRX’s Chief Operating Officer. Between September 1998 and 2004, Mr. Hadden was Executive Vice President, and between June 1998 and 2001, Mr. Hadden was also the firm’s Chief Financial Officer. From 1991 to 1995, and from 1997 to 1998, Mr. Hadden held various positions as an Associate at JP Morgan & Co., Inc. Mr. Hadden’s transaction experience includes mergers and acquisitions, investment banking, and venture investing, including health care and biotechnology. In June 1997, he earned an MBA from the Harvard University Graduate School of Business Administration. Mr. Hadden earned a BS in Management, summa cum laude, from Tulane University.
John D. Halpern, MBA was elected to the IRX Therapeutics Board of Directors in September 2013. He is a founder of Halpern, Denny & Co, a private equity investment firm.
Prior to forming Halpern, Denny & Co. in 1991, Mr. Halpern was a founder of Bain & Company and served as its Vice Chairman until 1990. For 15 years, he was Director of North American Client Development and Strategy. Prior to the formation of Bain & Company, Mr. Halpern was a consultant at Boston Consulting Group. He is a partner at Boston Common Press, the publisher of Cook’s Illustrated magazine and America’s Test Kitchen cookbooks. Mr. Halpern is a graduate of Yale University, magna cum laude, and a member of Phi Beta Kappa, who received an MBA from the Harvard Business School.
Ferid Murad, MD, PhD was elected to the IRX Therapeutics Board of Directors in March 2001. Dr. Murad was awarded the Lasker Prize in 1996 and the Nobel Prize in Physiology or Medicine in 1998 for his pioneering work on the role of nitric oxide as a central regulator of many biological responses.
Dr. Murad is currently University Professor and Director of the Institute of Cell Signaling at George Washington University, Washington, DC. From 1997 to 2011, he was at the University of Texas–Houston Medical School, where he was Professor and Chairman of the Department of Integrative Biology and Pharmacology and Director of the Institute of Molecular Medicine. Previously, Dr. Murad was Vice President of Pharmaceutical Research and Development at Abbott Laboratories and CEO and founder of Molecular Geriatrics Corporation.
From 1981 to 1988, Dr. Murad served as Professor of Medicine and Pharmacology, and Chief of Medicine, at the Palo Alto Veterans Hospital, and Associate Chairman and Chairman of Medicine at Stanford University, both in California. From 1970 to 1981, he was Professor of Medicine and Pharmacology, Director of Clinical Pharmacology, and Director of the Clinical Research Center at the University of Virginia.
Dr. Murad earned a BA from DePauw University and MD and PhD degrees from Case Western Reserve University. He was a resident in Internal Medicine from Massachusetts General Hospital and a fellow at the National Heart Institute. Dr. Murad is a member of the National Academy of Sciences and the Institute of Medicine as well as numerous societies and international academies. Among his many awards are 18 honorary degrees. Dr. Murad advises many universities, governments, and companies.
Lawrence M. Wolf, CPA was elected to the IRX Therapeutics Board of Directors in October 1999. Since September 1999, Mr. Wolf has served as Chief Executive Officer of Red Diamond, Ltd., where he is an investment advisor to the Hire family.
From September 1998 to September 1999, Mr. Wolf was a Partner with the international accounting firm of Arthur Andersen, LLP, and one of five partners in the Cleveland office responsible for an 80-person tax practice.
From January 1994 to August 1998, Mr. Wolf was a Senior Manager with Arthur Andersen, LLP. Mr. Wolf received a BS in Business Administration from Miami University.
Gregory T. Wolf, MD, FACS is Professor and Chairman Emeritus of the Department of Otolaryngology–Head and Neck Surgery at the University of Michigan Medical Center in Ann Arbor, MI. Dr. Wolf served as Chair of the department from 1993 to 2009. He obtained his undergraduate education at the University of Notre Dame and completed medical school at the University of Michigan. Dr. Wolf’s research interests include tumor immunology, immunotherapy, and cell biology. His clinical research has included studies of immunotherapy and chemotherapy regimens.
Dr. Wolf has served as the principal investigator on the phase 1 and phase 2a clinical trials of the IRX-2 Regimen in HNSCC and will continue to serve as principal investigator in the randomized phase 2b clinical trial in oral cavity SCC. He is Director of the NCI Head and Neck Cancer, Specialized Program of Research Excellence (S.P.O.R.E.) at the University of Michigan, which will play a pivotal role in collecting data findings for the phase 2b INSPIRE trial.
Dr. Wolf received national recognition as the leader of national clinical trials that have provided the foundation for changing the standard therapy for patients with advanced laryngeal cancers. He has authored more than 200 original research articles and book chapters and has been an invited speaker at countless regional, national, and international symposia. He was President of the American Head and Neck Society from 2007 to 2008. Dr. Wolf has dedicated his life to the care of patients and has been one of the most influential scientists in the history of head and neck cancer.
Arlene A. Forastiere, MD is Professor of Oncology at the Johns Hopkins University School of Medicine and Sidney Kimmel Comprehensive Cancer Center in Baltimore, MD. She is also Senior Vice President, Medical Affairs, at eviti, Inc. Dr. Forastiere is internationally recognized for research contributions that have established standards of care for the treatment of head and neck and esophageal cancers. She has been an advocate and leader for evidence-based practice and clinical trials participation.
Dr. Forastiere chaired the National Comprehensive Cancer Network guidelines panel for head and neck cancer until 2009, and led the head and neck committees of the Eastern Cooperative Oncology Group and Radiation Therapy Oncology Group. Dr. Forastiere served on the Board of Directors of the American Society of Clinical Oncology and was an Associate Editor for the Journal of Clinical Oncology from 1999-2010.
Dr. Forastiere completed a fellowship in hematology-oncology at Memorial Sloan-Kettering Cancer Center, New York, NY, and held faculty positions at the University of Maryland and the University of Michigan Medical School prior to joining the faculty of Johns Hopkins in 1988. She is the author and coauthor of more than 150 articles and 50 book chapters.
Michael J. Kaplan, MD is Professor of Otolaryngology–Head and Neck Surgery at Stanford University, Stanford, CA, and a Neurosurgery Member at Stanford Cancer Institute. Dr. Kaplan has been the Principal Investigator or coinvestigator on a number of clinical research projects, both Stanford University-initiated and industry-sponsored. He is on the Stanford Institutional Review Board and Scientific Review Committee that scrutinizes cancer-related proposed studies.
Dr. Kaplan collaborates closely with the head and neck oncology team, which includes surgical oncologists, medical oncologists, radiation oncologists, and research faculty. His scholarly interests are new therapeutic approaches for head and neck cancer, head and neck cancer stem cell identification, and characterization and development of innovative surgical methods at the anterior cranial base.
Dr. Kaplan received an MD degree from Harvard Medical School, Cambridge, MA.
Dr. Jatin P. Shah, MD, FACS has been Chief of the Head and Neck Service in the Department of Surgery since 1992 and also leads the Head and Neck Disease Management Team at Memorial Sloan Kettering Cancer Center (MSKCC), New York, NY. He is Professor of Surgery at the Weill Cornell Medical College and holds the Elliot W. Strong Chair in Head and Neck Oncology at MSKCC.
Dr. Shah founded the International Federation of Head and Neck Oncologic Societies and serves as its Chief Executive Officer. He serves on the editorial and review boards of 18 scientific journals and has published more than 300 peer-reviewed articles, 50 book chapters, and 7 books. Dr. Shah has been awarded honorary fellowships from the Royal Colleges of Surgeons of London, Edinburgh, and Australia, and honorary PhD degrees from the University of Athens and the Catholic University of Leuven in Belgium.
Dr. Shah received an MD degree from Medical College, University of Baroda (India) and completed his residency at the New York Infirmary.
Barbara Wollenberg, MD is Chair and Director of the Clinic for Otorhinolaryngology, Head and Neck Surgery at the University of Lübeck, Germany. Her research is focused on molecular, immunologic, and translational studies in head and neck cancer. Among her numerous awards was a Heisenberg Scholarship by the German Research Foundation in 2001 and appointment to membership in the National German Academy of Sciences Leopoldina in 2005.
Dr. Wollenberg is an editor of several otorhinolaryngologic journals and a member of several academic societies.
Dr. Wollenberg studied medicine at Saarland University in Saarbrücken and at Ludwig Maximilian University in Munich, both in Germany. She was a resident and consultant from 1988-2001 at Ludwig Maximilian University.