REG - GSK PLC - GSK enters agreement to acquire Aiolos Bio

GSKAnnouncement

09/01/2024 07:00

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RNS Number : 0752Z  GSK PLC  09 January 2024

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.

 

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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.

 

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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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