On September 11, 2017 IRX Therapeutics, Inc. (IRX) reported 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) (Free ESMO Whitepaper) Annual Congress 2017 (Press release, IRX Therapeutics, SEP 11, 2017, View Source [SID1234520497]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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) View Source (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
[email protected] or [email protected]
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 (Free ESMO Whitepaper) 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) reported 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) (Free ESMO Whitepaper) 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 (CIMT) (Free CIMT Whitepaper) (ICIC) in Mainz, Germany on September 8, 2017.
IRX will present the following poster presentation at ESMO (Free ESMO Whitepaper):
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 (Free ESMO Whitepaper) 2017 Congress can be found at View Source
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 View Source