GSK, moving fast to buy Aiolos, pays $1B to challenge Amgen, AstraZeneca for asthma market
上市批准临床3期并购临床2期免疫疗法
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来源: FierceBiotech
GSK moved quickly to add the long-acting anti-TSLP antibody to its portfolio,
Well, that was fast. Seventy seven days after Aiolos Bio launched to the public, GSK has disclosed a deal to buy the biotech and its phase 2 asthma treatment for $1 billion upfront and up to $400 million in regulatory milestones.
Aiolos broke cover in late October, launching with a $245 million series A round co-led by Atlas Venture, Bain Capital Life Sciences, Forbion and Sofinnova Investments. The biotech raised the money to fund the development of a long-acting anti-TSLP monoclonal antibody, AIO-001, that it picked up from Jiangsu Hengrui Pharmaceuticals two months earlier.
Other companies got to the TSLP opportunity before GSK. Amgen and AstraZeneca won FDA approval for an anti-TSLP antibody, Tezspire, late in 2021. Novartis hung a 'for sale' sign on its midphase TSLP prospect, CSJ117, months after the FDA authorized Tezspire.
GSK has weighed up the competition and bet up to $1.4 billion on AIO-001. In a statement, Tony Wood, chief scientific officer at GSK, called AIO-001 a potentially best-in-class medicine that could expand the company’s biologics portfolio to the 40% of severe asthma patients with low T2 inflammation.
Post-hoc analyses of phase 2/3 trials of Tezspire linked the antibody to reductions in exacerbations in T2 low asthmas, a subgroup that other drugs, including GSK’s Nucala and phase 3 prospect depemokimab, aren’t designed to treat. Tezspire’s broad efficacy led the FDA to make it the first asthma drug approved for severe asthma without phenotypic limitations, such as eosinophilic, or biomarker restrictions.
The belief that AIO-001 can improve on Tezspire rests, in part, on its dosing schedule. Tezspire is given subcutaneously once a month. GSK believes the “enhanced potency and half-life extension technology” of AIO-001 could support dosing every six months. The Big Pharma’s work on the HIV drugs Cabenuva and Apretude has shown how longer-lasting medicines can win market share.
GSK, which will acquire rights to AIO-001 outside of Greater China, plans to run a phase 2 trial in adults with asthma and is assessing whether to expand development into other indications, including chronic rhinosinusitis with nasal polyps. Amgen and AstraZeneca are running phase 3 trials of Tezspire in people with chronic rhinosinusitis and eosinophilic esophagitis.
The deal represents another successful exit for Aiolos CEO Khurem Farooq, who co-founded the biotech with Tony Adamis, M.D., after leading Gyroscope Therapeutics to an $800 million takeover by Novartis.
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