Brooklyn ImmunoTherapeutics Announces Presentation of Positive Results of IRX-2 Therapy in Resectable Breast Cancer and Head and Neck Cancer at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer

Statistically significant increase in tumor-infiltrating lymphocytes reported

PD-L1 upregulation in early stage breast cancer patients

Well-tolerated with no Grade III/IV treatment-emergent toxicities reported

BROOKLYN, NY, USA I November 11, 2018 I Brooklyn ImmunoTherapeutics, a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, and Providence Cancer Institute today announced the clinical results of IRX-2 therapy in resectable breast cancer and head and neck cancer that were presented in an oral presentation at the 2018 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on November 10th at the Walter E. Washington Convention Center in Washington, D.C.

IRX-2 is an allogeneic, cell-derived biologic with multiple active cytokine components, including IL-2, that act on various parts of the immune system to activate the entire tumor microenvironment.

“The clinical results presented today demonstrate that treatment with IRX-2 was associated with a mean 116% increase in tumor-infiltrating lymphocytes in patients with early stage breast cancer and a mean increase of 58% in head and neck squamous cell carcinoma,” said David B. Page, M.D., Earle A. Chiles Research Institute, a division of Providence Cancer Institute in Portland, Oregon, and the presenter at SITC’s 33rd Annual Meeting. “Moreover, IRX-2 therapy was also associated with an increase in PD-L1 RNA upregulation in the early stage breast cancer patients and was well-tolerated in both the breast cancer and head and neck cancer patients enrolled in these clinical trials. Together these results support the further evaluation of IRX-2 with anti-PD-1 and neoadjuvant chemotherapy in stage II-III triple negative breast cancer as well as ongoing follow-up of a randomized Phase 2 INSPIRE trial in head and neck cancer.”

“These highly encouraging clinical results support further study of IRX-2 as a potential important new immunotherapeutic drug candidate for the treatment of both breast cancer and head and neck cancer,” said Mark Leuchtenberger, interim President and CEO of Brooklyn ImmunoTherapeutics. “We believe that IRX-2, both as a single agent and in combination with other anti-cancer agents, can potentially improve patient outcomes in these difficult-to-treat indications as well as in the treatment of other cancers. On-going studies, including the Phase 2B INSPIRE trial and an investigator-sponsored trial in squamous cervical intraepithelial neoplasia 3 or vulvar intraepithelial neoplasia 3, are further exploring the potential of IRX-2 in treating cancer.”

Results

In the early stage breast cancer trial (ESBC), 16 patients were enrolled and evaluable for tumor-infiltrating lymphocyte (TIL) analysis, and the head and neck squamous cell carcinoma (HNSCC) trial is fully enrolled at 105 patients with 36 patients evaluable at the time of analysis. In both trials, all patients received all planned injections with no treatment-related surgical delays, complications, or treatment-related grade III/IV toxicities. Treatment was associated with a mean 116% relative increase in TILs (range –36% to +1275%, p = 0.02) in ESBC and a mean 58% relative increase (range –57 to +452%, p=0.01) in HNSCC. Treatment was associated with PD-L1 RNA upregulation in EBSC (mean +54%, range –53% to +185%, p=0.04). RNA analysis in ESBC and HNSCC revealed concordant increases in cytokine gene expression, including CXCL2, CCL4, CXCR4, and CXCL12 as well as transcription factors including FOS, ETS1, NFκB, EGR1/2 which are involved in T-cell activation and differentiation. Augmentation of ITGAE (CD103), a known marker of memory T-cell activation in EBSC cohort was also observed.

About Brooklyn ImmunoTherapeutics

Brooklyn ImmunoTherapeutics (formerly IRX Therapeutics) is focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, both as a single agent and in combination with other anti-cancer therapies.

Our most advanced program is studying the safety and efficacy of IRX-2 in patients with head and neck cancer. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.

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

About Earle A. Chiles Research Institute, a division of Providence Cancer Institute, at the Robert W. Franz Cancer Center in Portland, Ore.

Providence Cancer Institute, a part of Providence Health & Services, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally-renowned research. The Earle A. Chiles Research Institute, a division of Providence Cancer Institute, is a world-class research facility located within the Robert W. Franz Cancer Center. The institute’s main area of investigation is cancer immunotherapy, a specialized field of study focused on triggering the immune system to destroy cancer. Learn more at www.ProvidenceOregon.org/cancer.

SOURCE: Brooklyn ImmunoTherapeutics

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