Instil Bio Announces Voluntary Pause of Enrollment in Ongoing Clinical Trials Related to Manufacturing
October 31 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 that it has voluntarily paused enrollment
in its ongoing clinical trials of ITIL-168 and ITIL-306 and has
notified regulatory authorities in the United States, Canada, and
the UK. No regulatory agencies, including the FDA, have notified
the Company of a clinical hold in any of its clinical trials.
The voluntary pause by the Company was instituted following a
recent decrease in the rate of successful manufacturing of
ITIL-168, resulting in the inability to dose some patients whose
individual product of ITIL-168 was not successfully manufactured. A
pre-specified safety analysis in the DELTA-1 trial has been
conducted on patients who received ITIL-168 and did not identify
any unexpected safety issues. The Company has commenced an
end-to-end analysis of its manufacturing processes and upon
completion of this analysis, plans to take corrective actions to
improve the rate of manufacturing success and resume the study.
Although no manufacturing failures have been observed to date in
the ongoing Phase 1 trial of ITIL-306, the Company has also
voluntarily paused enrollment in this trial as part of its overall
manufacturing analysis.“We are committed to advancing TIL therapy
for the treatment of patients with cancer,” said Bronson Crouch,
Chief Executive Officer of Instil Bio. “This pause in enrollment
provides us an opportunity to refine our processes and enable us to
manufacture and deliver TIL therapies to patients with no other
treatment options. We have assembled a world-class technical
operations organization and leadership team to address the
challenges associated with manufacturing these therapies.”“With the
quality of our technical operations staff and our significant
experience in developing cell therapies, I am confident in our
ability to overcome obstacles in manufacturing,” said Tim Moore,
Chief Operating Officer of Instil Bio. “Our end-to-end
manufacturing analysis is being carried out to expeditiously
identify contributing causes, design solutions, and implement
corrective actions in order to resume clinical manufacturing.”
The Company intends to provide an update on the manufacturing
analysis by early Q1 2023. The Company confirms its previously
disclosed cash runway into 2025 upon the successful completion of a
potential sale-leaseback transaction of its Tarzana manufacturing
facility.
About Instil Bio
Instil Bio, Inc. (Nasdaq: TIL) is a clinical-stage
biopharmaceutical company focused on developing TIL therapies for
the treatment of patients with cancer. The Company has assembled an
accomplished management team with a successful track record in the
development, manufacture, and commercialization of cell therapies.
Using the Company’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
for multiple solid tumors. For more information visit
www.instilbio.com and LinkedIn.
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,” “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, the Company’s
investigation into its manufacturing processes of ITIL-168, the
implementation of corrective actions and resumption of clinical
trials, future updates about the Company’s clinical trials, the
Company’s cash runway, 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 and
the ability to overcome challenges related thereto; 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 Quarterly
Report on Form 10-Q for the quarter ended June 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.com Janhavi MohiteStern Investor
Relations1-212-362-1200janhavi.mohite@sternir.com |
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