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RX Therapeutics Presents Positive IRX-2 Phase 2a Head and Neck Squamous Cell Carcinoma Clinical Results at the European Society for Medical Oncology Annual Congress 2017

— 65% overall survival rate at 5 years —
— IRX-2 demonstrates ability to modulate tumor microenvironment —

NEW YORK – September 11, 2017 – IRX Therapeutics, Inc. (IRX) today presented results from a Phase 2a clinical trial of IRX-2, the company’s lead drug candidate, in head and neck squamous cell carcinoma (SCCHN) at the European Society for Medical Oncology (ESMO) Annual Congress 2017.

“The results presented today demonstrate that IRX-2, a primary cell-derived biologic, drives intratumoral immune infiltration of T cells, B cells and dendritic cells, promoting their activation.  This increase in lymphocyte infiltration was associated with reductions in tumor size and an overall survival rate of 65% at 5 years in patients with head and neck squamous cell carcinoma,” said Gregory T. Wolf, M.D., Professor Emeritus, Department of Otolaryngology-Head and Neck Surgery, University of Michigan Comprehensive Cancer Center.  “These data demonstrate that IRX-2 modulates the tumor microenvironment in cancer cells and may improve patient outcomes in this difficult-to-treat patient population.”

In a subset study of 7 patients, the study also demonstrated that IRX-2 upregulates immune checkpoint markers, including PDL1 and CTLA4 expression, suggesting that the effects of IRX-2 treatment may be enhanced by combination therapy with checkpoint inhibitors.  The clinical trial also demonstrated that IRX-2 promotes expression of chemokine pathway genes (CCLs,  CCRs, CXCLs and CXCRs), which are chemoattractants whose expression may result in increased lymphocyte infiltration.

“The data presented provides evidence that IRX-2 offers a durable improvement in head and neck cancer patient outcomes and has a unique mechanism of action that suggests restored immune function and activation in the tumor microenvironment,” said Mark Leuchtenberger, President and Chief Executive Officer of IRX Therapeutics.  “Based on these encouraging results, we are currently conducting a Phase 2b multicenter, randomized trial (INSPIRE) in neoadjuvant SCCHN.  We are also collaborating with investigators and companies with checkpoint inhibitors to assess IRX-2 as treatment for breast cancer (NCT02950259) and in multiple other tumor types with and without checkpoint inhibitors. We believe that IRX-2 has the potential to enhance patient outcomes across a variety of cancer indications and may also improve outcomes when used in combination with checkpoint inhibitors.”

About IRX Therapeutics and IRX-2

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, which data suggests may restore and activate multiple immune cell types, including T cells, dendritic cells, and natural killer cells, that are known to recognize and attack tumors. IRX-2 is a primary cell-derived biologic of produced by stimulation of human peripheral blood mononuclear cells (PBMCs) obtained from heathy donor whole blood. 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.

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) http://inspirehnc.com/ (clinicaltrials.gov NCT02609386) and in pre-operative early stage breast cancer (ESBC) (clinicaltrials.gov NCT02950259).

For more information about the Company and its clinical programs, please visit www.IRXTherapeutics.com.

Contacts

MacDougall Biomedical Communications
Rob Kloppenburg or Kara Mazey, 781-235-3060
rkloppenburg@macbiocom.com or kmazey@macbiocom.com

IRX Therapeutics to Present IRX-2 Clinical and Biomarker Updates at Upcoming Medical Conferences

— IRX-2 multiyear event free survival and overall survival Phase 2a clinical trial results to be presented at ESMO 2017 —
— INSPIRE Phase 2b head and neck cancer trial in progress to be presented at ICIC 2017 —

NEW YORK – August 2, 2017 – IRX Therapeutics, Inc. (IRX) today announced that a poster featuring clinical and biomarker results from a Phase 2a head and neck cancer clinical trial of IRX-2, the company’s lead drug candidate, will be presented on September 10, 2017 at the European Society for Medical Oncology (ESMO) Annual Congress in Madrid, Spain. In addition, a trial in progress poster of the Phase 2b INSPIRE clinical trial of IRX-2, in head and neck cancer, will be presented at the International Cancer Immunotherapy Conference (ICIC) in Mainz, Germany on September 8, 2017.

IRX will present the following poster presentation at ESMO:

Poster title: Immune profile analysis of head and neck squamous cell carcinoma before and after neoadjuvant treatment with the IRX-2 regimen
Date and Time: Sunday, September 10 from 13:15-14:15 (GMT+2)
Presentation number: 1062P

Full session details and data presentation listings for ESMO 2017 Congress can be found at http://www.esmo.org/Conferences/ESMO-2017-Congress/Programme.

IRX will present the following poster presentation at ICIC:

Poster title: INSPIRE: A multicenter randomized trial of neoadjuvant and adjuvant therapy with the IRX-2 regimen in patients with newly diagnosed stage II, III, or IVa squamous cell carcinoma of the oral cavity
Date and Time: Friday, September 8 from 18:15-20:15 (UTC+2)
Presentation number: B164

Full session details and data presentation listings for ICIC 2017 Conference can be found at http://www.cancerimmunotherapyconference.org/program-of-events/.

About IRX Therapeutics and IRX-2

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, which data suggests may restore and activate multiple immune cell types, including T cells, dendritic cells, and natural killer cells, that are known to recognize and attack tumors. IRX-2 is a primary cell-derived biologic produced by stimulation of human peripheral blood mononuclear cells (PBMCs) obtained from healthy donor whole blood. 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.

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 pre-operative early stage breast cancer (ESBC) (clinicaltrials.gov NCT02950259).

For more information about the company and its clinical programs, please visit www.IRXTherapeutics.com.

Contacts

MacDougall Biomedical Communications
Rob Kloppenburg or Kara Mazey, 781-235-3060
rkloppenburg@macbiocom.com or kmazey@macbiocom.com

IRX Therapeutics to Present at the BioCentury 24th Annual Future Leaders in the Biotech Industry Conference

NEW YORK – April 3, 2017 – IRX Therapeutics, Inc. (IRX) today announced that Mark Leuchtenberger, the Company’s President and Chief Executive Officer, will present a corporate overview at the BioCentury 24th Annual Future Leaders in the Biotech Industry Conference on Friday, April 7, 2017, at 3:00 p.m. Eastern time. The conference will be held at the Millennium Broadway Hotel & Conference Center in New York City.

About IRX Therapeutics

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.

Media Inquiries

MacDougall Biomedical Communications
Kari Watson, 781-235-3060
kwatson@macbiocom.com

IRX Therapeutics’ Board of Directors Announces New Senior Management Appointments of Mark Leuchtenberger and Monil Shah

 

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.

About IRX-2

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).

IRX-2 Phase 2a Results

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.

About IRX Therapeutics

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.