- 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.
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.
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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.
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