iTeos Announces First Patient Dosed in GALAXIES Lung-301 Phase 3 Study, Earning $35 Million in Milestones from GSK
2024年7月8日 - 8:00PM
iTeos Therapeutics, Inc. (Nasdaq: ITOS) (“iTeos”), a clinical-stage
biopharmaceutical company pioneering the discovery and development
of a new generation of immuno-oncology therapeutics for patients,
today announced the dosing of the first patient in GALAXIES
Lung-301, a global, randomized, double-blind Phase 3 registrational
clinical trial of belrestotug + dostarlimab versus placebo +
pembrolizumab in patients with first-line advanced, unresectable,
or metastatic PD-L1 high NSCLC. This event has triggered $35
million in development milestone payments from GSK, its partner for
belrestotug.
“Dosing the first patient in the GALAXIES
Lung-301 study marks a significant milestone for belrestotug +
dostarlimab. iTeos was founded with the goal of advancing
therapeutic options for patients by leveraging best-in-class
science. The decision to launch our first TIGIT:PD-1 doublet Phase
3 trial underscores our disciplined, data-driven investment
approach and was informed by several promising preliminary clinical
surrogates such as safety, ORR, and depth of response from the
latest interim analysis in May 2024,” said Michel Detheux, Ph.D.,
president and chief executive officer of iTeos. “We are excited
about the ongoing Phase 2 GALAXIES Lung-201 trial and look forward
to presenting data from the most recent interim analysis of this
study at a medical meeting in 2024.”
iTeos and GSK entered into an exclusive
development and commercialization collaboration in June 2021 for
belrestotug, an anti-TIGIT monoclonal antibody, enabling novel
next-generation immuno-oncology combinations. Per the agreement,
iTeos received a $625 million upfront payment from GSK with
development and regulatory milestones up to $550 million and
commercial milestones up to $900 million. In addition to the
milestones, GSK and iTeos will jointly commercialize and equally
split profits in the US. Outside the US, GSK will receive an
exclusive license for commercialization and iTeos will receive
tiered royalty payments. Within the collaboration, GSK and iTeos
share responsibility and costs for the global development of
belrestotug.
About iTeos Therapeutics,
Inc.iTeos Therapeutics is a clinical-stage
biopharmaceutical company pioneering the discovery and development
of a new generation of immuno-oncology therapeutics for patients.
iTeos Therapeutics leverages its deep understanding of tumor
immunology and immunosuppressive pathways to design novel product
candidates with the potential to restore the immune response
against cancer. The Company’s innovative pipeline includes three
clinical-stage programs targeting novel, validated
immunosuppressive pathways designed with optimized pharmacologic
properties for improved clinical outcomes, including the
TIGIT/CD226 axis and the adenosine pathway. iTeos Therapeutics is
headquartered in Watertown, MA with a research center in Gosselies,
Belgium.
About Belrestotug (EOS-448/
GSK4428859A)Belrestotug is an Fc active human
immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T
cell immunoglobulin and immunoreceptor tyrosine-based inhibitory
motif domains (TIGIT), an important inhibitory receptor which
contributes to the suppression of innate immune responses against
cancer. As an optimized high-affinity, potent anti-TIGIT mAb,
belrestotug is designed to enhance the antitumor response through a
multifaceted immune modulatory mechanism by engaging with TIGIT and
FcγR, a key regulator of immune responses which induces cytokine
release and antibody dependent cellular cytotoxicity (ADCC). The
therapeutic candidate is progressing in multiple indications in
collaboration with GSK.
Internet Posting of
InformationiTeos routinely posts information that may be
important to investors in the 'Investors' section of its website
at www.iteostherapeutics.com. The Company encourages investors
and potential investors to consult our website regularly for
important information about iTeos.
Forward-Looking StatementsThis
press release contains forward-looking statements. Any statements
that are not solely statements of historical fact are
forward-looking statements. Words such as “believe,” “anticipate,”
“plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,”
“potential,” “possible” and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements include statements relating to the potential benefits of
our product candidates and the expectation to present data from the
most recent interim analysis of the Phase 2 GALAXIES Lung-201 trial
at a medical meeting in 2024.
These forward-looking statements involve risks
and uncertainties, many of which are beyond iTeos’ control. Actual
results could materially differ from those stated or implied by
these forward-looking statements as a result of such risks and
uncertainties. Known risk factors include the following: success in
early clinical trials does not ensure that later clinical trials
will be successful, and early results from a clinical trial do not
necessarily predict final results; interim and early data may
change as more patient data become available and are subject to
audit and verification procedures; the expected benefits and
opportunities related to the agreement between iTeos and GSK may
not be realized or may take longer to realize due to a variety of
reasons, including challenges and uncertainties inherent in product
research and development and manufacturing limitations; and those
risks identified under the heading “Risk Factors” in iTeos’
Quarterly Report on Form 10-Q for the period ended March 31, 2024
filed with the Securities and Exchange Commission (SEC) as well as
other SEC filings made by the Company which you are encouraged to
review.
Any of the foregoing risks could materially and
adversely affect iTeos’ business, results of operations and the
trading price of iTeos’ common stock. We caution investors not to
place undue reliance on the forward-looking statements contained in
this press release. iTeos does not undertake any obligation to
publicly update its forward-looking statements other than as
required by law.
For further information, please
contact:
Investor Contact:Carl
MauchiTeos Therapeutics, Inc.carl.mauch@iteostherapeutics.com
Media
Contact:media@iteostherapeutics.com
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