On May 11, 2021 Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer and blood disorders, reported a publication in Breast Cancer Research that demonstrates how multiplex immunofluorescence (mIF) may be used to characterize the immunological activity of IRX-2 in early stage breast cancer (Press release, Brooklyn ImmunoTherapeutics, MAY 11, 2021, View Source [SID1234579706]). The publication, entitled "Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer," describes a methodology for mIF in conjunction with statistical modeling applied in a clinical trial collaboration between Providence Cancer Institute in Portland, Oregon, and Brooklyn.
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"Multiplex immunofluorescence combined with hierarchical linear modelling resulted in more precise estimates of treatment-related increases in stromal tumor infiltrating lymphocytes, PD-L1, and other metrics such as CD8+ tumor nest infiltration compared to conventional testing," said study principal investigator David Page, MD, medical oncologist and assistant member, Earle A. Chiles Research Institute, a division of Providence. "Hierarchical linear modeling can mitigate the effects of intratumoral heterogeneity on immune cell count estimations, allowing us to more efficiently detect treatment-related pharmocodynamic effects of an anticancer drug such as IRX-2. This may allow us to more effectively demonstrate treatment activity, and ultimately patient benefit, in the context of immunotherapy clinical trials."
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. The paper illustrates that IRX-2 increases immune cell infiltration and PD-L1 expression, suggesting that IRX-2 may hold promise in combination of PD-L1-targeted therapy in early stage breast cancer.
"We are excited to receive this validation for IRX-2 from an unbiased detection technology," said Howard Federoff, M.D., Ph.D., Chief Executive Officer and President of Brooklyn. "We recently initiated a combination trial evaluating IRX-2 with an immunotherapy that targets PD-1, in triple negative breast cancer, and we hope to explore additional combination approaches in various indications."
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 triple negative breast cancer (TNBC). Approximately 30 patients in total are expected to be enrolled. Patients with locally confirmed stage II-III TNBC are eligible. Patients will receive alternating regimens of the PD-1 inhibitor 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 rate, evaluated at the time of definitive surgery. For additional clinical trial details, refer to www.clinicaltrials.gov (NCT04373031).
This study is being supported in part by a multinational pharmaceutical company.