TIDMGSK
RNS Number : 7779B
GlaxoSmithKline PLC
14 June 2021
14 June 2021, London UK & Gosselies Belgium
GSK and iTeos Therapeutics announce development and
commercialisation collaboration for EOS-448, an anti-TIGIT
monoclonal antibody, enabling novel next-generation immuno-oncology
combinations
-- EOS-448 is currently in phase I for advanced solid tumours
with a randomised PD-1 combination study planned for 2022
-- iTeos to receive a $625 million upfront payment in addition
to potential milestones, and royalty payments on ex-US sales
-- GSK and iTeos will co-commercialise and share profits in the US
-- GSK now has the leading portfolio of antibodies targeting the CD226 axis - a key target for next-generation immuno-oncology therapies
GlaxoSmithKline plc (LSE/NYSE: GSK) and iTeos Therapeutics
(NASD: ITOS) 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 Details
iTeos 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) 607-1661
International 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 Oncology
GSK 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-448
EOS-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 Fc<GAMMA>R to trigger p
ro-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 Fc<GAMMA>R, 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 Statements
This 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 t o
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:
Media enquiries: Simon Steel +44 (0) 20 8047 (London)
5502
Tim Foley +44 (0) 20 8047 (London)
5502
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor James Dodwell +44 (0) 20 8047 (London)
enquiries: 2406
Sonya Ghobrial +44 (0) 7392 (Consumer)
784784
Mick Readey +44 (0) 7990 (London)
339653
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
iTeos enquiries:
Media contact: media@iteostherapeutics.com
Investor contact: Ryan Baker;
Ryan.Baker@iteostherapeutics.com
Cautionary statement regarding forward-looking statements
GSK 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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