NEW YORK – March 16, 2017 – IRX Therapeutics, Inc. (IRX) announced today that the Company’s Board of Directors has appointed Mark Leuchtenberger, as President, Chief Executive Officer and Director, and Monil Shah as Chief Operating Officer. Mr. Leuchtenberger and Dr. Shah are two biotechnology industry veterans who bring extensive experience in corporate and operational leadership and oncology drug development to IRX. IRX also announced that John W. Hadden II, a founder of IRX and its prior CEO, will continue as a Director.
“Today’s appointment of Mark Leuchtenberger and Monil Shah begins the next chapter in IRX’s development and affirms the Board’s commitment to delivering operating excellence to its partners and stakeholders,” said John W. Hadden II. “Mark is a highly experienced executive, ideally suited to lead IRX through its next stage of development, with a passion for advancing new therapies that address unmet patient needs. Monil has deep experience in oncology and immuno-oncology drug development that provides an excellent foundation from which to lead IRX’s operations.”
“On behalf of IRX stakeholders, I want to thank John for his leadership in building IRX Therapeutics and his role in recruiting Mark and Monil. We look forward to your continued involvement in advancing IRX,” said David Deming, Chairman of the Board, IRX Therapeutics.“I am excited to welcome Mark and Monil to IRX in their respective senior leadership capacities. Mark is a seasoned executive with private and public company experience, who has demonstrated a unique ability to build value advancing novel therapies. Monil has a proven track record of delivering outstanding operating results that will benefit IRX going forward.”
“I am very excited to join the team at IRX Therapeutics at this important inflection point in the company’s evolution,” said Mark Leuchtenberger. “The positive Phase 2a results for IRX-2, including encouraging 5-year survival data in squamous cell carcinoma of the head and neck, provide a strong basis for the growth of IRX Therapeutics in the area of immuno-oncology. I look forward to building on the extraordinary results that have been achieved to date so that we can make a difference in the lives of cancer patients.”
“IRX Therapeutics has a tremendous opportunity to advance the development of cancer immunotherapy based on data suggesting IRX-2 may be reversing immune suppression in the cancer tumor microenvironment,” said Monil Shah. “We believe this mechanism for immunomodulation may be synergistic with checkpoint inhibitors, and this is an exciting clinical opportunity that we intend to explore further. I look forward to working with Mark and the rest of the management team to build an organization that can help transform the treatment of cancer.”
Mark 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 co-founder of Albor Biologics, Inc. and Alvos Therapeutics, Inc. He served as non-executive 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 M.B.A. from the Yale School of Management and his B.A. from Wake Forest University.
Monil 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 B.S. and PharmD degrees from Rutgers, The State University of New Jersey and his M.B.A. from Florida Institute of Technology.
IRX-2 is a primary cell-derived biologic. Data collected to date suggest that IRX-2 reduces the immune suppression that is often seen in the cancer tumor microenvironment. This immunomodulatory activity appears to occur through the restoration of immune function and activation of a coordinated immune response against the tumor. IRX-2 is a proprietary therapeutic containing numerous active cytokine components, which restores and activates multiple immune cell types, including T cells, dendritic cells, and natural killer cells, that are able to recognize and destroy tumors. Currently, IRX-2 is being studied in an on-going 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 pre-operative early stage breast cancer (ESBC) (clinicaltrials.gov NCT02950259).
Data collected in a Phase 2a trial of patients with squamous cell carcinoma of the head and neck (SCCHN) demonstrated that neoadjuvant IRX-2 stimulated lymphocyte infiltration (LI) into the tumors, and greater LI was associated with longer survival. The overall 5-year survival rate was 65% (17/26), and in patients with a large change in LI after treatment, there was a greater than 80% probability of survival at 5 years (LIavg vs. survival, p<0.05).1 Of the 27 patients evaluable for safety, 85.2% experienced at least one treatment-emergent adverse event (TEAE), the most common (>10%) study drug-related TEAEs included nausea, injection site pain, headache, and dizziness. There were no drug-related deaths reported.2
1 Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen. Berinstein NL, Wolf GT, Naylor PH, et al. Cancer Immunol Immunother. 2012;61(6):771-782
2 Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer. Wolf GT, Fee WE, Dolan RW, et al. Head and Neck. 2011; 33:1666-74.
IRX Therapeutics is a clinical-stage company developing novel immunotherapies focused on reducing the immune suppression that is seen in the cancer tumor micro-environment, 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. For more information about the Company and its clinical programs, please visit www.IRXTherapeutics.com.