Brooklyn Immuno Therapeutics Releases Information on Irx-2 Phase 2 Head and Neck Cancer Study Findings

Brooklyn Immuno Therapeutics Releases Information on Irx-2 Phase 2 Head and Neck Cancer Study Findings

Results from the INSPIRE Phase 2 trial of IRX-2, multi-cytokine biologic immunotherapy, in patients with newly diagnosed stage II, III, or IVA squamous cell carcinoma of the oral cavity were released today by Brooklyn Immuno Therapeutics, Inc. (Nasdaq:BTX) (Brooklyn or the Company). Estimating 2-year Event-Free Survival (EFS) was the study’s primary goal, with overall survival (OS) and the safety of IRX-2 serving as important secondary outcomes. A total of 150 patients were included in the trial. The median EFS in the intention-to-treat (ITT, n=105) population at two years of follow-up was 48.3 months, however, it was not achieved in the control arm (Hazard Ratio 1.10 (95 percent Confidence Interval, 0.6-2.1; p value=0.62)).

Results preferred IRX-2 in significant pre-specified subgroups categorized by stage and kind of adjuvant therapy. Patients in these subgroups experienced EFS events in the IRX-2 armless more frequently than in the control group. In patients with later stage (III and IV) illness, EFS rates as determined by the Kaplan-Meier estimate at two years of follow-up were 57.2 (40.3, 70.9) vs. 49.4 (28.3, 67.4) in favor of IRX-2. The EFS Kaplan-Meier estimate at two years of follow-up was 76.4 (52.2, 89.4) versus 60.6 (29.4, 81.4) in favor of IRX-2 in patients who did not receive chemotherapy (radiation only) as part of adjuvant treatment. With IRX-2, no fresh safety indications were noticed.

For participating in this experiment, we appreciate the patients and their families, said Roger Sidhu, M.D., Brooklyn’s chief medical officer. In this patient population, IRX-2 immunotherapy treatment was given as a local subcutaneous injection and was well tolerated in the neoadjuvant setting for squamous cell head and neck cancer of the oral cavity. According to Matt Angel, Ph.D., CEO of Brooklyn, the INSPIRE research achieved its primary objective of identifying patient categories that may benefit from IRX-2 in the neoadjuvant environment. These optimistic results are a testament to the INSPIRE study’s design and present a clear way ahead for testing in patient categories who may benefit from treatment with IRX-2 in combination with checkpoint inhibitors. It is especially thrilling to consider the possibility of providing successful, well-tolerated treatment to patients with advanced head and neck cancer who are ineligible for chemotherapy.

About IRX-2

A primary cell-derived multi-cytokine biologic immunotherapy called IRX-2 is currently being developed for a variety of solid tumor purposes.IRX-2 is injected subcutaneously locally and works by stimulating T cells to produce an anti-tumor response.

About the INSPIRE Study

The INSPIRE project is a privately funded, open-label, phase 2 clinical trial comparing neoadjuvant therapy with IRX-2 versus standard of care in patients with newly diagnosed stage II, stage III, or stage IVA oral squamous cell carcinoma.

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