08.07.2024 13:00:06 - dpa-AFX: GNW-Adhoc: iTeos Announces First Patient Dosed in GALAXIES Lung-301 Phase 3 Study, Earning $35 Million in Milestones from GSK
WATERTOWN, Mass. and GOSSELIES, Belgium, July 08, 2024 (GLOBE NEWSWIRE) -- 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 Fc?R, 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 Information
iTeos routinely posts information that may be important to investors in the
'Investors' section of its website at www.iteostherapeutics.com
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about iTeos.
Forward-Looking Statements
This 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 Mauch
iTeos Therapeutics, Inc.
carl.mauch@iteostherapeutics.com
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