Instil Bio Announces Prioritization of Genetically Engineered CoStAR-TIL Program with ITIL-306 in Advanced Solid Tumors and Reduction in Workforce
December 08 2022 - 7:00AM
Instil Bio, Inc. (“Instil” or the “Company”) (NASDAQ: TIL), a
clinical-stage biopharmaceutical company focused on developing
next-generation tumor infiltrating lymphocyte, or TIL, therapies
for the treatment of patients with cancer, today announced a
reprioritization of its clinical programs to focus on development
of its CoStAR-TIL product candidates.
“From the beginning of Instil, we have been committed to
advancing TIL therapy by enhancing the native activity of TILs with
innovative strategies designed to improve product efficacy and
safety,” said Bronson Crouch, CEO of Instil Bio. “Although it was a
difficult decision to discontinue the development of ITIL-168, this
decision provides us the opportunity to accelerate the development
of CoStAR and other novel technologies to enhance TIL therapies for
patients. We are excited to resume dosing patients in the Phase 1
ITIL-306 study and anticipate providing initial data readouts next
year.”
Strategic Update
Instil has prioritized development of its proprietary,
genetically-engineered CoStAR-TIL programs, which are designed to
boost the efficacy of T cells by providing potent synthetic
costimulatory signals within the tumor microenvironment (TME).
Instil’s lead CoStAR-TIL program, ITIL-306, is in a Phase 1 dose
escalation trial in non-small cell lung cancer (“NSCLC”), ovarian
cancer, and renal cell carcinoma, with the first patient dosed
earlier this year. The Company expects to report data from the dose
escalation cohorts of the Phase 1 ITIL-306 study in 2023.
Instil is undertaking a reduction in its U.S. workforce of
approximately 60% to re-align its operating model from a
registration-focused company to a development-stage company.
ITIL-168 Program Update
Instil is discontinuing its ITIL-168 clinical programs, the
DELTA-1 trial in advanced melanoma and the DELTA-2 trial in NSCLC,
cervical cancer, and head and neck squamous cell carcinoma. After
an analysis of the potential scenarios to restart and complete a
registration-enabling cohort in advanced melanoma in the DELTA-1
trial, the Company has decided to prioritize the CoStAR-TIL
platform.
About Instil BioInstil Bio, Inc. (Nasdaq: TIL)
is a clinical-stage biopharmaceutical company focused on developing
next-generation TIL therapies for the treatment of patients with
cancer. The Company has assembled an accomplished management team
with a successful track record in the research, development,
manufacture, and commercialization of cell therapies. Instil is
advancing its lead CoStAR-TIL product candidate, ITIL-306, a
next-generation, genetically-engineered TIL therapy for multiple
solid tumors. For more information visit www.instilbio.com and
LinkedIn.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Words such as
“anticipates,” “believes,” “expects,” “future,” “intends,”
“potential,” “projects,” and “will” or similar expressions are
intended to identify forward-looking statements. Forward-looking
statements include statements concerning or implying our pipeline
of potential therapies and the development thereof, our plans
regarding enrollment in our ITIL-306 clinical trial and
expectations concerning the availability of initial clinical data
from such study and the timing thereof, 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 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; risks inherent in manufacturing and testing of
cell therapy products; the sufficiency of Instil’s cash resources;
our ability to achieve the expected benefits of our corporate
reorganization; and other risks and uncertainties affecting Instil
and its development programs, including those discussed in the
section titled “Risk Factors” in our Quarterly Report on Form 10-Q
for the quarter ended September 30, 2022 available on the SEC’s
website at www.sec.gov. 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:Media Contact:1-833-446-7845 Ext.
1009mediarelations@instilbio.comJanhavi MohiteStern Investor
Relations1-212-362-1200janhavi.mohite@sternir.com
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