iTeos Therapeutics (NASD: ITOS) and GlaxoSmithKline plc (LSE/NYSE:
GSK) today announced an agreement to co-develop and
co-commercialise EOS-448, an anti-TIGIT monoclonal antibody
currently in phase I development as a potential treatment for
patients with cancer. TIGIT, part of the CD226 checkpoint axis, has
demonstrated potential as a promising target for the next
generation of immuno-oncology therapies based on compelling
preclinical data and a phase II randomised clinical trial. With
this collaboration GSK is uniquely positioned with access to
antibodies that synergistically target all three known CD226
checkpoints - TIGIT, CD96 and PVRIG.
Dr Hal Barron, Chief Scientific Officer and President
R&D, GSK, said: “Immuno-oncology has transformed
cancer care but unfortunately less than 30 percent of patients
respond to treatment with the current leading immune checkpoint
inhibitors. Based on the underlying science, we believe that
combinations of a PD-1, TIGIT, CD96 and PVRIG inhibitor could
become transformative medicines for many patients with cancer. We
are excited to collaborate with the team at iTeos and together we
can play a leading role in the next generation of immuno-oncology
therapies.”
Since GSK validated the role of CD226 axis targets as important
in oncology, it has been strategically building a carefully
constructed set of assets to target this network of checkpoint
inhibitors. The addition of EOS-448 results in GSK being the only
company with antibodies targeting all three known checkpoints –
TIGIT (via EOS-448), CD96 (via GSK’608), and PVRIG (via GSK’562).
Together with GSK’s recently approved anti-PD-1, Jemperli
(dostarlimab), this comprehensive portfolio of potential next
generation immuno-oncology agents will be explored through various
novel combinations, including doublets and triplets, to evaluate
their potential to transform treatment options for patients with
multiple different cancers.
Michel Detheux, President and CEO, iTeos, said:
“Through this transformative collaboration, iTeos now has access to
GSK’s best-in-class resources which will provide us with a
significant advantage in a highly competitive, global market. We
have chosen GSK because of their commercial capabilities,
experience in immuno-oncology and their commitment to invest in the
rapid advancement of our TIGIT programme and create a clear path
forward for EOS-448. Inspired by the multifaceted mechanism of
action of EOS-448 and promising early results in clinical trials,
this collaboration allows us to accelerate and expand the clinical
development of EOS-448. We are more confident than ever in our
ability to succeed. This collaboration validates our science and
provides a catalyst for the future of iTeos. The collaboration with
GSK will allow our team to continue to develop next generation
immunotherapies starting with inupadenant, our highly
differentiated clinical-stage A2A adenosine receptor antagonist,
and to drive scientific innovation with our expertise in tumour
immunology to build our pipeline.”
EOS-448 is currently in an open-label phase I study in patients
with advanced solid tumours. GSK and iTeos plan to start
combination studies of EOS-448 with dostarlimab in 2022. GSK’608
(anti-CD96 being developed in collaboration with 23andMe) is in
phase I as monotherapy and in combination with dostarlimab. GSK
expects to submit an Investigational New Drug application for
GSK’562 (anti-PVRIG in-licensed as SRF-813 from Surface Oncology)
by mid-2022.
Under the terms of the collaboration agreement, iTeos will
receive an upfront payment of $625 million. iTeos will be eligible
to receive up to an additional $1.45 billion in milestone payments,
should the EOS-448 programme achieve certain development and
commercial milestones.
Within the collaboration, GSK and iTeos will share
responsibility and costs for the global development of EOS-448 and
will jointly commercialise and equally split profits in the US.
Outside of the US, GSK will receive an exclusive license for
commercialisation and iTeos will receive tiered royalty
payments.
The collaboration agreement is conditional upon customary
conditions including review by the appropriate regulatory agencies
under the Hart-Scott-Rodino Act.
Conference Call DetailsiTeos will host a
conference call to discuss the agreement today, Monday, June 14 at
8:30 a.m. ET. Details are as follows:
Participant Dial-In: (833) 607-1661International Dial-In: (914)
987-7874 Conference ID: 4598012 Webcast:
https://edge.media-server.com/mmc/p/xz7hasbz
The live audio webcast will also be accessible from the Events
page of the Company’s IR website at
https://investors.iteostherapeutics.com/news-and-events/events. A
replay will be available on the Company’s website approximately two
hours after completion of the event and for 30 days following the
call.
GSK in OncologyGSK is focused on maximising
patient survival through transformational medicines. GSK’s pipeline
is focused on immuno-oncology, cell therapy, cancer epigenetics and
synthetic lethality. Our goal is to achieve a sustainable flow of
new treatments based on a diversified portfolio of investigational
medicines utilising modalities such as small molecules, antibodies,
antibody drug conjugates and cells, either alone or in
combination.
About GSK GSK is a science-led global
healthcare company. For further information please visit
www.gsk.com/about-us.
About EOS-448EOS-448 is a monoclonal human IgG1
antibody designed to bind with high affinity TIGIT, a negative
co-stimulatory immune checkpoint expressed T cells and NK
cells. EOS-448 potently triggers an antitumor response by the
immune system via a multi-faceted mechanism. By binding to
TIGIT, EOS-448 blocks its interaction with TIGIT ligands including
CD155 and CD112, which can then bind to CD226 and activate immune
response of T cells and NK cells. In addition, IgG1 binds to FcγR
to trigger pro-inflammatory cytokine release, activation of antigen
presenting cells and depletion of TIGIT+ Tregs and exhausted T
cells. In a phase 1 dose escalation, presented at AACR 2021,
EOS-448 showed a favorable tolerability profile and early signs of
clinical activity in advanced cancers with one confirmed partial
response and 9 stable diseases out of 20 evaluable patients with
advanced, difficult to treat cancers. Depletion of TIGIT+
suppressive and exhausted cells were shown at even the lowest
tested dose thereby providing evidence of engagement of the FcγR,
and the potential of EOS-448 to activate multiple immune
mechanisms. This program was funded by a SPW/EER grant.
About iTeos Therapeutics, Inc.iTeos
Therapeutics is a clinical-stage biopharmaceutical company
pioneering the discovery and development of a new generation of
highly differentiated immuno-oncology therapeutics for patients.
The Company’s innovative pipeline includes two clinical-stage
programs targeting novel, validated immuno-oncology. The initial
antibody product candidate, EOS-448, is a high affinity, potent,
anti-TIGIT antibody with a functional Fc domain, designed to
enhance the anti-tumor response through a multifaceted immune
modulatory mechanism. An open-label Phase 1 clinical trial of
EOS-448 is ongoing in adult cancer patients with advanced solid
tumors with preliminary data indicating preliminary clinical
activity as a monotherapy and a favorable tolerability profile. The
Company is also advancing inupadenant, a first insurmountable
adenosine A2A receptor antagonist in clinical development tailored
to overcome cancer immunosuppression. iTeos is conducting an
open-label multi-arm Phase 1/2a clinical trial of inupadenant in
adult cancer patients with advanced solid tumors. Preliminary
results indicate encouraging single-agent activity as well as the
identification of a potential predictive biomarker. iTeos
Therapeutics is headquartered in Cambridge, MA with a research
center in Gosselies, Belgium.
iTeos Therapeutics, Inc. Forward-Looking
StatementsThis press release contains forward-looking
statements and information within the meaning of The Private
Securities Litigation Reform Act of 1995 and other federal
securities laws. Any statements contained in this press release
that are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "will," "intends," "potential,"
"possible" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements
include but are not limited to statements regarding the closing of
the transaction; iTeos’ right to receive any upfront payment,
milestones and royalty payments from GSK pursuant to the agreement
and GSK’s obligation to share responsibility and costs for the
global development of EOS-448; EOS-448’s potential as a promising
target for the next generation of immuno-oncology therapies; the
potential of combinations of TIGIT, CD96 and PVRIG to become
transformative medicines for many patients with cancer; GSK’s
best-in-class resources providing iTeos with a
significant advantage in a highly competitive global market; the
potential of the collaboration with GSK to accelerate and expand
the clinical development of EOS-448; iTeos’ plan to continue
to develop next generation immunotherapies starting with
inupadenant; and GSK and iTeos’ plan to start combination
studies of EOS-448 with dostarlimab in 2022.
These forward-looking statements involve risks and uncertainties
that may cause actual results to differ materially from those
expressed or implied in the forward-looking statements. Many
of these risks and uncertainties are beyond iTeos’ control.
Known risk factors include, among others, market conditions, the
expected benefits and opportunities related to the agreement
between iTeos and GSK may not be realized or may take
longer to realize than expected due to a variety of reasons,
including any inability of the parties to perform their commitments
and obligations under the agreement, challenges and uncertainties
inherent in product research and development and manufacturing
limitations; success in preclinical testing and 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; the data for EOS-448 may not be
sufficient for obtaining regulatory approval; iTeos may
not be able to execute on its business plans, including meeting its
expected or planned regulatory milestones and timelines, research
and clinical development plans, and bringing its product candidates
to market, for various reasons, some of which may be outside
of iTeos’ control, including possible limitations of company
financial and other resources, manufacturing limitations that may
not be anticipated or resolved for in a timely manner, regulatory,
court or agency decisions such as decisions by the United States
Patent and Trademark Office with respect to patents that cover our
product candidates and the impact of the COVID-19 pandemic; and
those risks identified under the heading “Risk Factors”
in iTeos’s most recent Annual Report on Form 10-K for the
year ended December 31, 2020 and most recent Quarterly Report on
Form 10-Q 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
the Company’s business, results of operations and the trading price
of iTeos’ common stock. We caution investors not to place
considerable reliance on the forward-looking statements contained
in this press release. iTeos does not undertake any
obligation to publicly update its forward-looking statements based
on events or circumstances after the date hereof.
GSK
enquiries: |
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Media enquiries: |
Simon Steel |
+44 (0) 20 8047 5502 |
(London) |
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Tim Foley |
+44 (0) 20 8047 5502 |
(London) |
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Kristen Neese |
+1 804 217 8147 |
(Philadelphia) |
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Kathleen Quinn |
+1 202 603 5003 |
(Washington DC) |
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Analyst/Investor enquiries: |
James Dodwell |
+44 (0) 20 8047 2406 |
(London) |
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Sonya Ghobrial |
+44 (0) 7392 784784 |
(Consumer) |
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Mick Readey |
+44 (0) 7990 339653 |
(London) |
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Jeff McLaughlin |
+1 215 751 7002 |
(Philadelphia) |
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Frannie DeFranco |
+1 215 751 4855 |
(Philadelphia) |
iTeos enquiries:
Media contact: media@iteostherapeutics.comInvestor contact: Ryan
Baker; Ryan.Baker@iteostherapeutics.com
Cautionary statement regarding forward-looking
statementsGSK cautions investors that any forward-looking
statements or projections made by GSK, including those made in this
announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Such
factors include, but are not limited to, those described in the
Company's Annual Report on Form 20-F for 2020 and any impacts of
the COVID-19 pandemic.
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