Instil Bio Announces Poster Presentations of CoStAR Platform at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting
November 08 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 poster presentations of pre-clinical data
and trial-in-progress for the ongoing ITIL-306 Phase 1 clinical
trial using the CoStimulatory Antigen Receptor (CoStAR) platform at
the 37th Annual Meeting of the Society for Immunotherapy of Cancer
(SITC), to be held from November 8-12, 2022.
Pre-clinical data demonstrating the activity of CoStAR across
physiologically-relevant ranges of FRα expression and TCR affinity
are featured in Poster 282. These data
demonstrated that CoStAR amplified T-cell responses at all FRα
expression levels as long as FRα was expressed, supporting the
clinical exploration of ITIL-306 in multiple solid tumor types with
a variety of FRα expression levels. Furthermore, CoStAR-expressing
cells do not respond to FRα in the absence of TCR stimulation,
underscoring the expected safety profile of the CoStAR platform.
Currently, ITIL-306 is being evaluated in a first-in-human Phase 1
dose escalation clinical study for treatment of refractory solid
tumors with the first patient dosed in October 2022.
The company also is presenting a trial-in-progress poster
summarizing the design of the ongoing Phase 1 study of ITIL-306
(Poster 776). ITIL-306-201 is a Phase 1
multicenter, single-arm, dose escalation and expansion study
evaluating the safety and feasibility of ITIL-306 in adult patients
with advanced epithelial ovarian cancer (EOC), non-small cell lung
cancer (NSCLC), and renal cell carcinoma (RCC) who relapsed from or
are refractory to ≥1 prior line of systemic therapy. Importantly,
the Phase 1 study of ITIL-306 features a treatment regimen free of
high-dose interleukin-2.
Details of the poster presentations are as follows:
Title: Anti-folate receptor alpha (FRα) CoStimulatory
Antigen Receptor (CoStAR) improves T-cell function across
physiologically relevant ranges of FRα expression and T-cell
receptor (TCR) affinitiesAuthors: Martina Sykorova,
Michelle Mojadidi, Leyuan Bao, Eric Gschweng, Milena Kalaitsidou,
Gray Kueberuwa, Xingliang (Tim) Zhou, Rubén Alvarez-Rodríguez, John
S. BridgemanPoster/Abstract Number: 282
Title: ITIL-306-201: A multicenter, first-in-human phase
1a/1b study of ITIL-306, an engineered autologous
tumor-infiltrating lymphocyte (TIL) cell therapy product, in adults
with advanced solid tumorsAuthors: Jeffrey Ward, Armin
Ghobadi, John B. Liao, Adam Schoenfeld, Scott S. Tykodi, Yizhou
Jiang, John Le Gall, Ruben Alvarez-Rodriguez, Marika Sherman,
Tiffany Singson, Jeff McLeroyPoster/Abstract Number: 776
The posters are available on the publications section of the
Instil Bio website: www.instilbio.com/publications.
About Instil BioInstil 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 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 the potential
of our product candidates to positively impact quality of life and
alter the course of disease in the patients we seek to treat, our
research, development and regulatory plans for our product
candidates, the timing of our ongoing and potential future clinical
trials and studies and the availability of data therefrom,
including our expectations concerning the clinical exploration of
ITIL-306 in multiple solid tumor types with a variety of FRα
expression levels, the expected safety profile of the CoStAR
platform, 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, 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, and 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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