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, today announced 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. 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.

“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.

About Brooklyn ImmunoTherapeutics

Brooklyn is 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. The company is also exploring opportunities to advance oncology and blood disorder therapies using leading edge gene editing/cell therapy technology through the newly acquired license from Factor Bioscience and Novellus.

Brooklyn’s 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 Brooklyn and its clinical programs, please visit www.BrooklynITx.com.

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. Investigators lead more than 400 active clinical trials in key areas such as cancers of the: breast, colon/rectum, prostate, lung, esophagus, liver and pancreas, head and neck, ovary, skin and blood. Other studies are investigating treatments for COVID-19. Learn more at providenceoregon.org/cancer.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, concerning Brooklyn's expectations, anticipations, intentions, beliefs or strategies regarding the future that are not statements of historical fact, including statements in the fourth and fifth paragraphs related to potential future development and growth. These statements are based upon the current beliefs and expectations of Brooklyn's management and are subject to significant risks, uncertainties and other factors. Brooklyn’s actual results could differ materially from any anticipated future results, performance or achievements described in the forward-looking statements as a result of a number of factors, including, but not limited to: (i) Brooklyn’s ability to successfully, cost-effectively and efficiently develop its technology and products; (ii) Brooklyn’s ability to successfully commence clinical trials of any products on a timely basis or at all; (iii) Brooklyn’s ability to successfully fund and manage the growth of its development activities; (iv) Brooklyn’s ability to obtain regulatory approvals of its products for commercialization; and (v) uncertainties related to the impact of the COVID-19 pandemic on the business and financial condition of Brooklyn, including on the timing and cost of the BR-202 clinical trial. Additional factors and risks are described in Brooklyn’s periodic reports filed with the Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to Brooklyn on the date of this press release, and Brooklyn assumes no obligation to update the information contained in this press release.

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