SAN DIEGO, July 26, 2022 (GLOBE NEWSWIRE) — Brooklyn ImmunoTherapeutics, Inc. (Nasdaq:BTX) (“Brooklyn” or the “Company”) today announces 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.
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.
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.
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.
Brooklyn is focused on developing advanced therapies using state-of-the-art mRNA cell engineering technology. Brooklyn has multiple next-generation cell and gene-editing therapies in preclinical development for various indications. For more information about Brooklyn, please visit www.BrooklynITx.com.
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 Brooklyn, including on the timing and cost of its clinical trials. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this communication speak only as of the date on which they were made, and Brooklyn does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as required by applicable law. Factors that may cause Brooklyn’s actual results from those expressed or implied in forward-looking statements contained in this press release are more fully disclosed in Brooklyn’s periodic public filings with the U.S. Securities and Exchange Commission, particularly under the heading “Risk Factors” in Brooklyn’s Annual Report on Form 10-K for the year ended December 31, 2021, as well as under similar headings in Brooklyn’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
Michael V. Morabito, Ph.D.