Experienced business and scientific leadership

IRX Therapeutics

IRX Therapeutics: a clinical-stage company developing novel immunotherapies

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).

Management Team

Mark Leuchtenberger, MBA

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

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.

James Egan, PhD, MBA

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.

Board of Directors

Mark Leuchtenberger, MBA, Chairman, President and CEO

Mark Leuchtenberger was elected to the IRX Therapeutics Board of Directors in March 2017. He is the President and Chief Executive Officer of IRX Therapeutics. 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.

George P. Denny III

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.

Luba Greenwood

Luba Greenwood was elected to the IRX Therapeutics Board of Directors in October 2017. She brings to IRX a wealth of pharmaceutical and biotechnology industry experience, expertise in building innovative technology companies and providing strategic counsel to global corporations.

Her career has spanned leadership roles in venture investing, business development, mergers & acquisitions, law, consulting and operations. Luba recently served as Venture Partner at Colt Ventures, and led business development and strategy for Pronutria, a Flagship VenturesLabs company. Prior to that, Luba served as Senior Mergers & Acquisitions Counsel at Pfizer Inc. Currently, Luba is an adjunct professor at Boston University School of Management and Boston University Law School. She has served on the board of the Longwood Symphony Orchestra, is a co-chair of MassBio’s Entrepreneur’s University, mentor for the MIT 100K Entrepreneurship Competition, and a judge for MassChallenge and the Young Entrepreneurs Initiative. Luba received a J.D. from Northeastern University and a B.A. from Brandeis University.

John D. Halpern

Mr. John D. Halpern serves as a Partner of Halpern, Denny & Co. Mr. Halpern co-founded Halpern, Denny & Co. He is also a Partner at Boston Common Press. Prior to this, Mr. Halpern was for a period of 15 years, the Director of North American Client Development and Strategy, Founder, and Vice Chairman of Bain & Company, where he personally advised the Chief Executives of many Fortune 100 companies. During this period, Bain & Company grew at a 30 percent annual rate of more than $200 million in consulting revenue and developed a unique reputation for a practical, hands-on approach to business transformation. At Bain & Company, Mr. Halpern was the second largest shareholder and served as the Vice Chairman until 1990. Prior to the formation of Bain & Company, Mr. Halpern was a Consultant at Boston Consulting Group. He is a Member of the Board of Directors of Heartlab, Tealuxe, Johnny Rockets Group, and All Seasons Services, Inc. He served as Director of IRX Therapeutics Inc. Mr. Halpern was previously a Member of the Board of Directors of Barneys New York. He received an M.B.A. from the Harvard Business School and is a graduate of Yale University, magna cum laude and Phi Beta Kappa.

Ferid Murad, MD, PhD

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

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.