a0755z
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of January 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued: 9 January 2024, London UK
GSK enters agreement to acquire Aiolos Bio
●
Acquisition expands GSK's
respiratory pipeline adding AIO-001, a phase II-ready, long-acting
antibody targeting the clinically validated TSLP
pathway
● AIO-001 could redefine the standard-of-care with
dosing every six months
●
AIO-001 has potential
to expand GSK's respiratory biologics portfolio to reach a broader
portion of asthma patients
GSK plc (LSE/NYSE: GSK) and Aiolos Bio, Inc. (Aiolos) today
announced that they have entered into an agreement under which GSK
will acquire Aiolos, a clinical-stage biopharmaceutical company
focused on addressing the unmet treatment needs of patients with
certain respiratory and inflammatory conditions, for a $1 billion
upfront payment and up to $400 million in certain success-based
regulatory milestone payments.
The acquisition provides GSK with access to Aiolos' AIO-001, a
potentially best-in-class, long-acting anti-thymic stromal
lymphopoietin (TSLP) monoclonal antibody ready to enter phase II
clinical development for the treatment of adult patients with
asthma, with potential for additional indications including chronic
rhinosinusitis with nasal polyps. AIO-001 was exclusively licensed
to Aiolos outside of Greater China by Jiangsu Hengrui
Pharmaceuticals Co., Ltd. (Hengrui).
Tony Wood, Chief Scientific Officer, GSK, said: "We
have a proud heritage and deep development expertise in respiratory
medicines, especially addressing diseases driven by IL-5 with high
levels of eosinophils or high T2 inflammation. Adding AIO-001, a
potentially best-in-class medicine targeting the TSLP pathway,
could expand the reach of our current respiratory biologics
portfolio, including to the 40% of severe asthma patients with low
T2 inflammation where treatment options are still
needed."1
Targeting the TSLP pathway addresses a key driver of the
inflammatory response in major allergic and inflammatory diseases.
TSLP is a clinically validated target in the treatment of asthma
regardless of biomarker status. Early studies of AIO-001 have shown
initial safety, tolerability, pharmacokinetics, and biological
activity in healthy volunteers and asthma patients. Additionally,
AIO-001 has potential to be administered every six months due to
its enhanced potency and half-life extension technology, which
could redefine the standard-of-care.
GSK has an industry-leading portfolio of marketed and
investigational medicines to address a range of respiratory
diseases, including biologics aimed at treating the subset of
asthma patients with high levels of eosinophils or high T2
inflammation. With AIO-001, GSK's respiratory portfolio could
provide the option of a biologic to a broader portion of the 315
million patients living with asthma regardless of biomarker status
and including those with low T2 inflammation.2
Khurem Farooq, Chief Executive Officer, Aiolos Bio, said:
"We believe that this
transaction speaks to the high potential of our long-acting
anti-TSLP monoclonal antibody, AIO-001. By uniting with GSK, a
leader with decades of experience developing respiratory therapies
and a shared commitment to improving patient lives, we're confident
that we can rapidly advance this therapy in the hopes of
significantly reducing the treatment burden for
patients."
Financial considerations
Under
the terms of the agreement, GSK will pay a $1 billion upfront
payment and up to $400 million in certain success-based regulatory
milestone payments. In addition, GSK will also be responsible for
success-based milestone payments as well as tiered royalties owed
to Hengrui.
This transaction is subject to customary conditions, including
applicable regulatory agency clearances under the Hart-Scott-Rodino
Act in the US.
About Aiolos Bio
Founded
in 2023, Aiolos Bio is a San Francisco, USA and London, UK-based
clinical-stage, private, biopharmaceutical company dedicated to
revolutionising the treatment landscape for respiratory
disease.
About AIO-001
AIO-001
is a novel monoclonal antibody with potential for longer dosing
intervals, such as every 6 months, due to its half-life extension
and differentiated potency. AIO-001 binds to the human thymic
stromal lymphopoietin (TSLP) ligand to inhibit TSLP signalling.
TSLP has a validated, central role in driving inflammation,
including in asthma.
About GSK in respiratory
For
more than 50 years, GSK has led the way in developing medicines
that advance the management of respiratory conditions, from
introducing the world's first selective short-acting beta agonist
in 1969 to launching 13 respiratory medicines and six vaccines to
create today's industry-leading respiratory portfolio. We are
investing in innovative science to transform patient outcomes in
existing and new respiratory disease areas and are pushing the
frontiers of respiratory science to improve the lives of millions
of patients living with respiratory conditions.
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at gsk.com.
GSK enquiries
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Media:
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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Sarah Clements
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+44 (0) 20 8047 5502
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(London)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Lyndsay Meyer
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+1 202 302 4595
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(Washington DC)
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Investor Relations:
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Nick Stone
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+44 (0) 7717 618834
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mick Readey
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+44 (0) 7990 339653
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(London)
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Josh Williams
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+44 (0) 7385 415719
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(London)
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Camilla Campbell
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+44 (0) 7803 050238
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(London)
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Steph Mountifield
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+44 (0) 7796 707505
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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Frannie DeFranco
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+1 215 751 4855
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(Philadelphia)
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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 under Item 3.D
'Risk factors" in the company's Annual Report on Form 20-F for
2022, and Q3 Results for 2023.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1
Frank C. Albers , Hana Müllerová , Necdet B. Gunsoy ,
Ji-Yeon Shin , Linda M. Nelsen , Eric S. Bradford , Sarah M. Cockle
& Robert Y. Suruki (2018) Biologic treatment eligibility for
real-world patients with severe asthma: The IDEAL study, Journal of
Asthma, 55:2, 152-160.
2
To T, Stanojevic S, Moores G, Gershon AS, Bateman ED, Cruz AA, et
al. . Global asthma prevalence in adults: findings from the
cross-sectional world health survey. BMC Public Health (2012)
12:204.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: January
09, 2024
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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