GlaxoSmithKline joins Sosei’s who’s-who list of clients with global licensing pact for IBD small molecules

Big drugmakers are on the hunt for novel therapeutics in a range of ultra-competitive therapeutic areas. Japan’s Sosei Heptares has emerged in recent years as a sought-after partner for Big Pharmas seeking novel neuro candidates — but now GlaxoSmithKline wants to try the preclinical R&D expert’s work in inflammatory bowel disease.

GSK has tapped Sosei Heptares for discovery work targeting IBD and other gastrointestinal immune disorders with small-molecule agonists for GPR35, an orphan G protein-coupled receptor (GPCR) with a genetic link to those conditions, the companies said Sunday.

As part of the deal, Sosei will lead preclinical R&D on agonists identified by its structure-based drug design platform and proprietary StaR technology, and will hand clinical work, manufacturing and commercialization to GSK. The British drug giant will hold global commercial licensing rights to any winning candidates and will hand an initial $44 million for near-term development milestones and research funding. Sosei will also be due up to $437 million pending a series of development, regulatory and commercialization milestones.

“Using genetics to prioritise potential treatments for a challenging immune disorder like IBD exemplifies the approach we are taking at GSK to develop novel transformative medicines,” John Lepore, GSK’s senior VP of research, said in a release. “Sosei Heptares is a world leader with an established track record in GPCR drug discovery, so we are confident in our potential to jointly identify high quality clinical candidates to deliver important new medicines for the millions of patients who are waiting.”

It’s a big-name pickup for Sosei, which has made its name in licensing out early-stage GPR targeting candidates to major drugmakers, most notably AbbVie and Roche’s Genentech. Malcolm Weir, Sosei’s vice chairman, touted GSK’s existing expertise in IBD and extensive clinical experience as a major draw for Sosei’s licensing strategy.

“In our minds, (this deal) was very driven by a group that we can work with and collaborate effectively,” Weir said. “But, it’s a project that still needs to work itself out in the clinic.”

Weir predicted a clutch of Sosei candidates would see the clinic in the “near-term” future but declined to guess on exactly when that would be. The Japanese company has made its name identifying GPCR candidates, mostly specializing in neuroscience, Weir said. While IBD is a mostly new endeavor, Sosei thinks there’s potential in that therapeutic area.

“What we did was looked at a fair number of novel targets and there was evidence of genetic associations with diseases like ulcerative colitis and other disorders,” Weir said. “We were very struck by that and struck by the promise of that.”

Back in June, AbbVie tapped Sosei in a very similar deal, agreeing to pay $32 million upfront for a range of inflammatory and autoimmune diseases with potential option, development and commercial payments of up to $377 million. That deal could expand, however, if AbbVie chooses to execute on all four targets in the pact; in that case, the agreement could grow into the billion-dollar range, a Sosei spokesperson said at the time.

That was actually Sosei’s second deal with AbbVie after the company signed a deal with Allergan — which AbbVie acquired in mid-2019 — back in 2016 for a slate of subtype-selective muscarinic receptor agonists. In that deal, Sosei got $125 million upfront with a $50 million commitment toward Phase II studies in addition to over $3 billion in promised milestones.

In July 2019, Genentech also jumped on board with Sosei, agreeing to front $26 million in upfront and near-term payments, in addition to future milestone payments that may exceed $1 billion, as well as potential royalties. The targeted therapeutic areas weren’t disclosed in that deal. Sosei has also signed previous pacts with British drugmakers AstraZeneca and Novartis, among a suite of other Big Pharmas.

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