Brooklyn ImmunoTherapeutics Announces Presentation of Ongoing Investigator Sponsored Trial of IRX-2 Regimen Combined with Nivolumab in Recurrent/Metastatic Solid Tumors

BROOKLYN, N.Y.–(BUSINESS WIRE)–Brooklyn
ImmunoTherapeutics, a biopharmaceutical company focused on exploring
the role that cytokine-based therapy can have in treating patients with
cancer, today announced the presentation of an ongoing trial poster at
the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting on
May 31 – June 4, 2019 at the McCormick Place in Chicago, IL. The poster
describes a Phase 1b study to evaluate the safety, determine
the recommended Phase 2 dose and investigate the biologic and clinical
activity of IRX-2 in combination with nivolumab in solid tumor
indications (NCT03758781).

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.

“Anti-PD-1 therapy in oncology has been demonstrated to be a safe and
effective therapeutic approach in treating certain cancers and increased
lymphocyte infiltration has been associated with improved patient
outcomes,” said Rohit K Jain, M.D. M.P.H., principal investigator on the
Phase 1b trial and Assistant Member in Moffitt Cancer Center Department
of Genitourinary Oncology. “In data collected to date, IRX-2 has
demonstrated an increase immune activation in the tumor microenvironment
and was correlated with greater progression free survival and overall
survival in a Phase 2 study in head and neck cancer. This clinically
observed increased immune activation suggests the combination of IRX-2
therapy with PD-1 blockade with nivolumab could enhance outcomes
compared to PD-1 blockade alone. This robust Phase 1b trial in up to
five different indications will help us better understand the potential
role of IRX-2 in oncology immunotherapy.”

The Phase 1b clinical trial is taking place at Moffitt Cancer Center in
Tampa, Florida and is currently recruiting patients.

“IRX-2 has been well-tolerated to date in clinical trials while
demonstrating encouraging activity in squamous cell cancer of the head
and neck,” said Mark Leuchtenberger, interim President and CEO of
Brooklyn ImmunoTherapeutics. “We believe the mechanism of action as well
as the safety and clinical activity shown to date provides a strong
rationale for combining IRX-2 with checkpoint inhibitors such as
nivolumab for the treatment of solid tumor cancers. We look forward to
the results of this important trial as well as the results of other
ongoing studies, including the Phase 2B INSPIRE trial and an
investigator-sponsored trial in squamous cervical intraepithelial
neoplasia 3 or vulvar intraepithelial neoplasia 3.”

About the Phase 1b Trial
Patients with recurrent or
metastatic renal cell carcinoma, urothelial carcinoma, non-small cell
lung cancer, HNSCC and melanoma are eligible. Patients who have received
prior anti-PD-1/PD-L1 antibodies are eligible. The IRX-2 regimen
consists of cyclophosphamide 300mg/m2 (Day 1) and subcutaneous IRX-2
injections for 10 days every 3 months. Nivolumab is administered at 240
mg once every two weeks. Planned total enrollment of approximately 100
patients. The study will include cohorts of the 5 different diseases.
Each cohort will include two groups: 1) anti-PD-1/PD-L1 antibody naïve
tumors, and 2) progressed during or after anti-PD-1/PD-L1 antibodies.

The primary study objective is to determine safety and tolerability of
combination therapy. Secondary objectives are to evaluate the objective
response rate, progression-free survival, and overall survival. The
study is actively accruing patients.

About Brooklyn ImmunoTherapeutics
Brooklyn
ImmunoTherapeutics (formerly IRX Therapeutics) is focused on 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.

Our 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 the company and its clinical programs, please
visit www.BrooklynITx.com.

About Moffitt
Moffitt is dedicated to one lifesaving
mission: to contribute to the prevention and cure of cancer. The
Tampa-based facility is one of only 50 National
Cancer Institute-designated Comprehensive Cancer Centers, a
distinction that recognizes Moffitt’s excellence in research, clinical
trials, prevention and cancer control. Moffitt is the No. 6 cancer
hospital in the nation and has been listed in U.S.
News & World Report as one of the “Best Hospitals” for cancer
care since 1999. Moffitt devotes more than 2.5 million square feet to
research and patient care. Moffitt’s expert nursing staff is recognized
by the American Nurses Credentialing Center with Magnet^®
status, its highest distinction. With more than 6,500 team members,
Moffitt has an economic impact in the state of $2.1 billion. For more
information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org,
and follow the momentum on Facebook,
Twitter
and YouTube.

Contacts

Media Contact
MacDougall (for Brooklyn ImmunoTherapeutics)
Karen
Sharma
[email protected]
781-235-3060

Moffitt Cancer Center
Kim Polacek, APR, CPRC
[email protected]
813-745-7408