Instil Bio Announces IND Clearance of First CoStAR-TIL program, ITIL-306, Designed to Enhance Activity in the Tumor Microenvironment
May 27 2022 - 7:00AM
Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage
biopharmaceutical company focused on developing tumor infiltrating
lymphocyte, or TIL, therapies for the treatment of patients with
cancer, today announced IND clearance by the U.S. Food and Drug
Administration (“FDA”) of ITIL-306, Instil’s first
genetically-engineered Costimulatory Antigen Receptor TIL
(CoStAR-TIL) therapy, as well as the presentation of supporting in
vivo CoStAR data at the 2022 ASCO Annual Meeting.
“TILs have shown the ability to achieve complete
responses in patients with solid tumors that are refractory to
approved therapies, making these cells both a meaningful therapy
for patients and a platform for innovation and next-generation
therapies,” said Bronson Crouch, Chief Executive Officer of Instil
Bio. “CoStAR is designed to leverage the diversity and
tumor-specificity of native TILs while enhancing their anti-tumor
activity to improve the efficacy of TILs.”
“TIL therapy can be limited by T cell
exhaustion, which can be caused by chronic antigen stimulation in
the absence of costimulation, conditions often found in the
immunosuppressive tumor microenvironment,” said Mark Dudley, PhD,
Chief Scientific Officer of Instil Bio. “CoStAR is designed to
address this challenge by providing synthetic costimulation in the
tumor microenvironment to increase proliferative potential and
improve the effector function of T cells, which may boost the
efficacy of TILs.”
ITIL-306 is an autologous TIL cell therapy
engineered with a novel and proprietary Costimulatory Antigen
Receptor (CoStAR) that is activated by folate receptor alpha (FRα)
to provide robust costimulatory signals. CoStAR builds on the key
advantages of native TILs, including their polyclonal anti-tumor
reactivity, to enhance the cytokine release, cytolytic activity,
and proliferation of TILs in the tumor microenvironment. The design
of Instil’s first-in-human Phase 1 study of ITIL-306 will enroll
patients with non-small cell lung cancer (NSCLC), ovarian cancer,
and renal cell carcinoma (RCC) and will start with a dose of one
billion CoStAR-transduced TILs. Manufacturing for ITIL-306 will
occur at Instil’s Tarzana, California manufacturing facility.
“CoStAR was designed to enhance the clinical
activity of TILs and expand the reach of TIL therapy into solid
tumor indications which have presented challenges for
immunotherapy,” said Zachary Roberts, MD, PhD, Chief Medical
Officer of Instil Bio. “Based on extensive preclinical data
supporting a novel mechanism of action lending markedly improved
function, proliferation and persistence of CoStAR-expressing cells,
we have designed the initial ITIL-306 clinical regimen to feature a
significantly reduced dose of lymphodepleting chemotherapy and no
post-infusion IL-2, a mainstay of unmodified TIL regimens. We
believe these features of the study design are a first for the TIL
field and were selected to improve patient safety while maximizing
CoStAR’s clinical potential.”
The poster presentation at the 2022 ASCO Annual
Meeting will outline findings from studies evaluating anti-FOLR1
CoStAR T cells in vitro as well as a mouse solid tumor model in
vivo. The poster presentation highlights results demonstrating
enhanced T cell function and tumor control by CoStAR-modified T
cells. Importantly, improved tumor control in a mouse solid tumor
model occurred without exogenous IL-2 administration, supporting a
clinical CoStAR-TIL regimen free of high-dose IL-2. CoStAR T cells
showed limited upregulation of PD-1 after target exposure and
demonstrated improved persistence in vivo.
Details of the poster presentation are as
follows:
Title: Antitumor activity of T
cells expressing a novel anti-folate receptor alpha (FOLR1)
costimulatory antigen receptor (CoStAR) in a human xenograft murine
solid tumor model and implications for in-human
studiesSession Type: Poster SessionSession
Title: Developmental
Therapeutics—ImmunotherapyPoster: 190Date
& Time: Sunday June 5, 2022, 9:00 AM
EDTAbstract Number: 2535
Additional information about the presentation
and the ASCO Annual Meeting is available on the ASCO website.
About Instil Bio
Instil Bio, Inc. (Nasdaq: TIL) is a
clinical-stage biopharmaceutical company focused on developing
tumor infiltrating lymphocyte, or TIL, therapies for the treatment
of patients with cancer. Instil has assembled an accomplished
management team with a successful track record in the development,
manufacture, and commercialization of cell therapies. Using
Instil's proprietary, optimized, and scalable manufacturing
processes at its in-house manufacturing facilities, Instil is
advancing its lead TIL product candidate, ITIL-168, for the
treatment of advanced melanoma and other solid tumors as well as
ITIL-306, a next-generation, genetically-engineered TIL therapy
using the CoStAR platform for multiple solid tumors. For more
information visit www.instilbio.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as “anticipates,” “expects,”
“future,” “intends,” “may,” “target,” and “will,” or similar
expressions are intended to identify forward-looking statements.
Forward-looking statements include statements concerning or
implying the therapeutic potential of our product candidates,
including ITIL-306; our research, development and regulatory plans
for our product candidates; the design and timing of our ongoing
and potential future clinical trials and studies and the
availability of data therefrom, including our expectations
concerning the enrollment and initiation of a Phase 1 study of
ITIL-306; the potential for ITIL-306 to provide synthetic
costimulation in the tumor microenvironment to increase
proliferative potential and improve the effector function of T
cells; our expectations concerning the manufacturing of ITIL-306;
the potential for us to make submissions concerning, and for our
product candidates to receive, regulatory approval from the FDA or
equivalent foreign regulatory agencies and whether, if approved,
these product candidates will be successfully distributed and
marketed; and other statements that are not historical fact.
Forward-looking statements are based on management’s current
expectations and are subject to various risks and uncertainties
that could cause actual results to differ materially and adversely
from those expressed or implied by such forward-looking statements,
including risks and uncertainties associated with the costly and
time-consuming cell therapy product development process and the
uncertainty of clinical success, including risks related to failure
or delays in successfully initiating, enrolling, reporting data
from or completing clinical studies, as well as the risks that
results obtained in pre-clinical studies or clinical trials to date
may not be indicative of results obtained in ongoing or future
trials and that Instil’s product candidates may otherwise not be
effective treatments in their planned indications; the ongoing
COVID-19 pandemic, which could materially and adversely affect
Instil’s business and operations, including Instil’s ability to
timely initiate, enroll and complete its ongoing and future
clinical trials; the time-consuming and uncertain regulatory
approval process; additional regulatory risks associated with
developing our product candidates for use in combination with other
therapies or third-party product candidates; risks inherent in the
manufacturing and testing of cell therapy products; the sufficiency
of Instil’s cash resources, and other risks and uncertainties
affecting Instil and its development programs, including those
discussed in the section titled “Risk Factors” in our Annual Report
on Form 10-K for the year ended December 31, 2021 available on the
SEC’s website at www.sec.gov, and in our Quarterly Report on Form
10-Q for the quarter ended March 31, 2022 to be filed with the SEC.
Additional information will be made available in other filings that
we make from time to time with the SEC. Such risks may be amplified
by the impacts of the COVID-19 pandemic. Accordingly, these
forward-looking statements do not constitute guarantees of future
performance, and you are cautioned not to place undue reliance on
these forward-looking statements. These forward-looking statements
speak only as of the date hereof, and we disclaim any obligation to
update these statements except as may be required by law.
Contacts:
Investor
Relations1-972-499-3350investorrelations@instilbio.comwww.instilbio.comJanhavi
MohiteStern Investor
Relations1-212-362-1200janhavi.mohite@sternir.com |
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