On June 3, 2019 Brooklyn ImmunoTherapeutics, a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, reported the presentation of an ongoing trial poster at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31 – June 4, 2019 at the McCormick Place in Chicago, IL (Press release, Brooklyn ImmunoTherapeutics, JUN 3, 2019, View Source [SID1234536842]). The poster describes a Phase 1b study to evaluate the safety, determine the recommended Phase 2 dose and investigate the biologic and clinical activity of IRX-2 in combination with nivolumab in solid tumor indications (NCT03758781).
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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.
"Anti-PD-1 therapy in oncology has been demonstrated to be a safe and effective therapeutic approach in treating certain cancers and increased lymphocyte infiltration has been associated with improved patient outcomes," said Rohit K Jain, M.D. M.P.H., principal investigator on the Phase 1b trial and Assistant Member in Moffitt Cancer Center Department of Genitourinary Oncology. "In data collected to date, IRX-2 has demonstrated an increase immune activation in the tumor microenvironment and was correlated with greater progression free survival and overall survival in a Phase 2 study in head and neck cancer. This clinically observed increased immune activation suggests the combination of IRX-2 therapy with PD-1 blockade with nivolumab could enhance outcomes compared to PD-1 blockade alone. This robust Phase 1b trial in up to five different indications will help us better understand the potential role of IRX-2 in oncology immunotherapy."
The Phase 1b clinical trial is taking place at Moffitt Cancer Center in Tampa, Florida and is currently recruiting patients.
"IRX-2 has been well-tolerated to date in clinical trials while demonstrating encouraging activity in squamous cell cancer of the head and neck," said Mark Leuchtenberger, interim President and CEO of Brooklyn ImmunoTherapeutics. "We believe the mechanism of action as well as the safety and clinical activity shown to date provides a strong rationale for combining IRX-2 with checkpoint inhibitors such as nivolumab for the treatment of solid tumor cancers. We look forward to the results of this important trial as well as the results of other ongoing studies, including the Phase 2B INSPIRE trial and an investigator-sponsored trial in squamous cervical intraepithelial neoplasia 3 or vulvar intraepithelial neoplasia 3."
About the Phase 1b Trial
Patients with recurrent or metastatic renal cell carcinoma, urothelial carcinoma, non-small cell lung cancer, HNSCC and melanoma are eligible. Patients who have received prior anti-PD-1/PD-L1 antibodies are eligible. The IRX-2 regimen consists of cyclophosphamide 300mg/m2 (Day 1) and subcutaneous IRX-2 injections for 10 days every 3 months. Nivolumab is administered at 240 mg once every two weeks. Planned total enrollment of approximately 100 patients. The study will include cohorts of the 5 different diseases. Each cohort will include two groups: 1) anti-PD-1/PD-L1 antibody naïve tumors, and 2) progressed during or after anti-PD-1/PD-L1 antibodies.
The primary study objective is to determine safety and tolerability of combination therapy. Secondary objectives are to evaluate the objective response rate, progression-free survival, and overall survival. The study is actively accruing patients.