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 (
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
“The INSPIRE study achieved its primary objective of identifying patient populations that may benefit from IRX-2 in the neoadjuvant setting,” said
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.
About
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, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are any statements that are not statements of historical fact and may be identified by terminology such as “believe,” “could,” “estimate,” “anticipate,” “expect,” “plan,” “possible,” “potential,” “project,” “will” or other similar words and the negatives of such words. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those stated or implied in any forward-looking statement as a result of various factors, including, but not limited to, uncertainties related to: (i) the evolution of Brooklyn’s business model into a platform company focused on cellular, gene editing and cytokine programs; (ii) Brooklyn’s ability to successfully, cost-effectively and efficiently develop its technology and products; (iii) Brooklyn’s ability to successfully commence clinical trials of any products on a timely basis or at all; (iv) Brooklyn’s ability to successfully fund and manage the growth of its development activities; (v) Brooklyn’s ability to obtain regulatory approvals of its products for commercialization; and (vi) uncertainties related to the impact of the COVID-19 pandemic on the business and financial condition of
Investor Relations Contact: Solebury Trout 917-936-8430 investors@brooklynitx.com Media Contact:Michael V. Morabito , Ph.D. Solebury Trout 917-936-8430 btx@soleburytrout.com
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