Brooklyn ImmunoTherapeutics Announces Publication of Results of IRX-2 Monotherapy in Early Stage Breast Cancer in Breast Canc...
May 11 2021 - 7:30AM
Business Wire
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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version on businesswire.com: https://www.businesswire.com/news/home/20210511005303/en/
Media Contact: MacDougall Nicholas Chang 781-235-3060
nchang@macbiocom.com
Investor Relations Contact : CORE IR 516-222-2560
investors@brooklynitx.com
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