Brooklyn ImmunoTherapeutics Announces Initiation of Phase 2 Trial of IRX-2 in Combination with Pembrolizumab and Chemotherapy in Triple Negative Breast Cancer

In Clinical Studies News by Barbara Jacoby

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By: Brooklyn ImmunoTherapeutics



Brooklyn ImmunoTherapeutics LLC (“Brooklyn”), a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, today announced the initiation of an open-label Phase 2 clinical trial of IRX-2 in combination with pembrolizumab (Keytruda®) and chemotherapy in triple negative breast cancer (TNBC). The trial will be conducted at the Providence Cancer Institute in Portland, Oregon.

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 associated with activation of the entire tumor microenvironment.

“In a Phase 1b clinical trial in early stage breast cancer, IRX-2 was well-tolerated as a single agent with no Grade 3 or 4 toxicities in patients and encouraging signs of activity including upregulation of PD-L1,” said principal investigator David Page, M.D., medical oncologist and assistant member, Earle A. Chiles Research Institute, a division of Providence Cancer Institute. “These results provide a strong rationale for studying IRX-2 in combination with pembrolizumab, an immunotherapy that targets PD-1, and standard of care chemotherapy in triple negative breast cancer, a disease for which there is an urgent need for new treatment options.”

“IRX-2 is currently being studied in a range of cancer indications, both as a single agent and in combination with other anti-cancer therapies, including checkpoint inhibitors,” said Lynn Sadowski Mason, Executive Vice President, Clinical Operations of Brooklyn ImmunoTherapeutics. “We believe that the unique combination of cytokines in IRX-2 can improve outcomes for patients with solid tumor cancers based on its ability to activate the immune system in the tumor microenvironment. We look forward to the results of this clinical trial and to exploring potential new indications in the future.”

About the Phase 2 Trial

The Phase 2 randomized, open-label trial is designed to assess the efficacy and safety of IRX-2 in patients with TNBC. Approximately 30 patients in total are expected to be enrolled. Patients with locally confirmed TNBC who have previously untreated locally advanced non-metastatic TNBC are eligible. Patients will receive alternating regimens of Pembrolizumab plus chemotherapy and subcutaneous IRX-2 injections twice a day for 10 days as neoadjuvant therapy prior to surgery. The primary efficacy endpoint is pathological Complete Response (pCR), and patients will be evaluated following definitive surgery. Please refer to (NCT04373031) for additional clinical trial details.

This study is being supported in part by a research grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

About Brooklyn ImmunoTherapeutics

Brooklyn ImmunoTherapeutics 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

About Providence Cancer Institute

Providence Cancer Institute, a part of Providence St. Joseph Health, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally renowned research. Providence Cancer Institute is home to the Earle A. Chiles Research Institute, a world-class research facility located within the Robert W. Franz Cancer Center in Portland, Oregon, and is a recognized leader in the field of cancer immunotherapy since 1993. To learn more, visit