GSK Enters Agreement to Acquire Aiolos Bio

Rhea-AI Summary

GSK plc (GSK) acquires Aiolos Bio, Inc. (Aiolos) for $1 billion upfront, expanding its respiratory pipeline with AIO-001, a phase II-ready, long-acting antibody targeting the clinically validated TSLP pathway. AIO-001 has the potential to redefine the standard-of-care with dosing every six months, reaching a broader portion of asthma patients.

Insights

Financial Analyst

The acquisition of Aiolos Bio by GSK for a $1 billion upfront payment, along with the potential for an additional $400 million in regulatory milestone payments, represents a significant investment in GSK's future respiratory product pipeline. This deal not only increases GSK's assets in the biologics space but also demonstrates the company's strategy to focus on high-potential, long-acting biologic treatments for respiratory conditions. The financial commitment suggests GSK's confidence in AIO-001 as a potentially transformative therapy for asthma patients, a market that includes over 315 million individuals worldwide.

From a financial perspective, the upfront cost and milestone payments will impact GSK's cash reserves and short-term expenditures. However, the potential long-term revenue from a successful biologic that could be administered semi-annually could justify the investment. Investors should monitor the progress of AIO-001 through clinical development, as each phase will be critical in determining the therapy's commercial viability and its impact on GSK's financial performance. The deal also includes tiered royalties owed to Hengrui, which will affect the profitability of the drug.

Medical Research Analyst

The acquisition of Aiolos Bio by GSK centers around AIO-001, a long-acting anti-TSLP monoclonal antibody. TSLP, or thymic stromal lymphopoietin, is a cytokine implicated in the pathogenesis of various inflammatory diseases, including asthma. Targeting TSLP has been clinically validated to help manage asthma, making AIO-001 a promising candidate for patients who do not respond well to existing treatments. The fact that AIO-001 is phase II-ready underscores its advanced position in the drug development pipeline, which is a critical stage for evaluating efficacy and safety in a larger patient population.

The biologic's potential to be administered every six months could significantly reduce the treatment burden for patients and improve adherence, which is often a challenge with more frequent dosing regimens. The extended half-life and enhanced potency of AIO-001 could lead to improved patient outcomes and a competitive advantage in the biologics market. The broad application of the drug, including for patients with low T2 inflammation, suggests that it could address a significant unmet need in the asthma treatment landscape.

Market Research Analyst

GSK's acquisition of Aiolos Bio and its AIO-001 asset is a strategic move to broaden its respiratory biologics portfolio. By targeting a different inflammatory pathway, TSLP, GSK is positioning itself to capture a larger share of the asthma treatment market, particularly among the 40% of severe asthma patients with low T2 inflammation—a demographic currently underserved by existing biologic therapies. The potential for AIO-001 to expand the market to include patients with chronic rhinosinusitis with nasal polyps further indicates GSK's intent to diversify its biologics offerings and cater to a wider patient population.

The introduction of a biologic with semi-annual dosing could disrupt the current asthma treatment paradigm, which primarily consists of daily or monthly therapies. If AIO-001 proves to be effective, it could set a new standard of care and generate significant market demand. Stakeholders, including competitors, will likely monitor this development closely as it could prompt shifts in research focus and competitive strategies within the respiratory therapeutics sector.

• 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

SAN FRANCISCO & LONDON--(BUSINESS WIRE)-- 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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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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FAQ

What did GSK acquire from Aiolos Bio, Inc.?

GSK acquired Aiolos Bio, Inc. for $1 billion upfront, expanding its respiratory pipeline with AIO-001, a phase II-ready, long-acting antibody targeting the clinically validated TSLP pathway.

What is the potential of AIO-001?

AIO-001 has the potential to redefine the standard-of-care with dosing every six months, reaching a broader portion of asthma patients.

What are the financial terms of the acquisition?

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.

What is the target of AIO-001?

AIO-001 targets the TSLP pathway, addressing a key driver of the inflammatory response in major allergic and inflammatory diseases, including asthma.

What are the implications for Aiolos Bio, Inc.?

Aiolos Bio, Inc. will benefit from the acquisition by uniting with GSK, a leader with decades of experience developing respiratory therapies, and advancing their therapy to reduce the treatment burden for patients.