On July 26, 2022 Brooklyn ImmunoTherapeutics, Inc. (Nasdaq:BTX) ("Brooklyn" or the "Company") reported that results from the INSPIRE phase 2 trial of IRX-2, a multi-cytokine biologic immunotherapy, in patients with newly diagnosed stage II, III, or IVA squamous cell carcinoma of the oral cavity (Press release, Brooklyn ImmunoTherapeutics, JUL 26, 2022, View Source [SID1234616939]).

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The primary endpoint of the study was to estimate 2-year Event-Free Survival (EFS) with key secondary endpoints of Overall Survival (OS) and safety of IRX-2. One hundred and fifty patients were enrolled in the study. At two years of follow-up in the intention-to-treat (ITT, n=105) population the median EFS was 48.3 months and was not reached in the control arm (Hazard Ratio 1.10 (95% Confidence Interval, 0.6-2.1; p value=0.62)).

In key pre-specified subgroups defined by stage and type of adjuvant treatment, outcomes favored IRX-2. Patients in these subgroups were less likely to experience an EFS event in the IRX-2 arm compared to control. Trends in EFS rates as defined by the Kaplan-Meier estimate at two years of follow-up in patients with later stage (III and IV) disease were 57.2 (40.3, 70.9) vs 49.4 (28.3, 67.4) in favor of IRX-2. In patients that did not receive chemotherapy (radiation only) as part of adjuvant treatment, the EFS Kaplan-Meier estimate at two years of follow-up was 76.4 (52.2, 89.4) vs 60.6 (29.4, 81.4) in favor of IRX-2. There were no new safety signals observed with IRX-2. Adverse events related to study treatment were higher in the IRX-2 arm than the control arm (55.9% vs 40%) and were driven primarily by injection site reactions and fatigue.

"We thank the patients and their families for their participation in this trial," said Roger Sidhu, M.D., Brooklyn’s Chief Medical Officer. "IRX-2 immunotherapy treatment was administered as a local subcutaneous injection and was well tolerated in this patient population with squamous cell head and neck cancer of the oral cavity in the neoadjuvant setting. We observed compelling trends in favor of IRX-2 in patients with higher stage disease and those that did not receive chemotherapy as part of adjuvant treatment, representing patient populations with high unmet need and who comprise a significant proportion of patients with head and neck cancer. The mechanism of action of IRX-2 and prior preclinical and translational studies of IRX-2 suggest potential synergy with checkpoint inhibitors and represents a novel combination immunotherapy strategy to explore in patients that may not be eligible for or require intensive adjuvant treatment."

"The INSPIRE study achieved its primary objective of identifying patient populations that may benefit from IRX-2 in the neoadjuvant setting," said Matt Angel, Ph.D., Brooklyn’s CEO. "These encouraging results are a testament to the design of the INSPIRE study and provide a clear path forward for testing in patient populations that may benefit from treatment with IRX-2 in combination with checkpoint inhibitors. The potential to offer an effective, well tolerated treatment to patients with advanced head and neck cancer who are ineligible for chemotherapy is particularly exciting."

The Company plans to present the results of the INSPIRE study at a scientific conference later this year.

About IRX-2
IRX-2 is a primary cell-derived multi-cytokine biologic immunotherapy in development for multiple solid tumor indications. IRX-2 is administered locally by subcutaneous injection and is designed to activate T cells to generate an anti-tumor response.

About the INSPIRE Study
The INSPIRE study is a Company-sponsored, randomized (2:1 IRX-2 vs control), open label, phase 2 estimation trial of neoadjuvant therapy with IRX-2 compared to standard of care in patients with newly diagnosed stage II, III, or IVA squamous cell carcinoma of the oral cavity.