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IRX Therapeutics Announces Initiation of Phase 2 Clinical Trial of IRX-2 in Squamous Cervical or Vulvar Intraepithelial Neoplasia 3

— Study is being conducted at USC Norris Comprehensive Cancer Center —

NEW YORK – February 14, 2018 – IRX Therapeutics, Inc. (IRX) today announced that the first patient has been dosed in an investigator-sponsored Phase 2 double-blind, randomized, placebo-controlled clinical trial of IRX-2 in women with squamous cervical intraepithelial neoplasia 3 (CIN3) or vulvar intraepithelial neoplasia 3 (VIN3). The clinical trial is being conducted at the University of Southern California (USC) Comprehensive Cancer Center in Los Angeles, California.

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.

“Current treatment options for severe cervical and vulvar intraepithelial neoplasia can cause substantial short-term morbidity as well as longer term risks to fertility, sexual function and pregnancy outcomes and so there is a great need for new treatment options,” said Lynda Roman, MD, Division of Gynecologic Oncology, USC Norris Comprehensive Cancer Care Center. “This clinical trial will study the potential of IRX-2 to restore the immune system of women diagnosed with CIN3 or VIN3 to prevent recurrent dysplasia.”

CIN 3 and VIN 3 are usually caused by certain types of human papillomavirus (HPV) and are found when a biopsy is done. If not treated, these abnormal cells may become cancerous and spread to nearby normal tissue. Overall, at least 75-80% of sexually active women will have acquired a genital HPV infection by age 50.

“We believe there is a strong mechanistic and clinical rationale for studying IRX-2 in the treatment of CIN3 and VIN3,” said Mark Leuchtenberger, President and Chief Executive Officer, IRX Therapeutics. “An earlier pilot study in 10 patients with early stage cervical cancer demonstrated that IRX-2 was well tolerated with encouraging signs of efficacy. IRX-2 is currently being studied in multiple other indications including an international Phase 2b study in squamous cell cancer of the head and neck and an investigator-sponsored Phase 1b study in breast cancer.”

About the Phase 2 CIN3 VIN3 Study

The CIN3 VIN3 study is a double blind, randomized, placebo-controlled trial. The IRX 2 regimen will include cyclophosphamide on Day 1 (three days before the start of IRX 2), IRX 2 daily for 4 days; and indomethacin, zinc with multivitamins, and a proton pump inhibitor (omeprazole) for 21 days. All treatments will be repeated at 6 weeks, for a total of two cycles. Patients will be randomized 2:1 to the treatment arm with the goal of enrolling 30 patients in the CIN3 cohort and 30 patients in the VIN3 cohort. The primary endpoint is pathological objective response at week 25. For more information, please go to clinicaltrials.gov: CIN3 VIN3 clinical trial

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) as well as in a Phase 1b investigator-sponsored trial in pre-operative early stage breast cancer (ESBC) and triple negative breast cancer (TNBC) (clinicaltrials.gov NCT02950259) and a Phase 2 investigator-sponsored trial in squamous cervical intraepithelial neoplasia 3 (CIN3) or squamous vulvar intraepithelial neoplasia 3 (VIN3) (clinicaltrials.gov NCT03267680).

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

Media Inquiries

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