Sotatercept

Like Merck & Co.’s pulmonary arterial hypertension drug Winrevair—which brought in $1.4 billion last year—HS235 targets the activin receptor signalling pathway.\n When GSK’s new CEO Luke Miels told investors last month that “smart business development” is a key pillar for his strategy, he wasn’t lying. The British Big Pharma has just announced its second biotech acquisition in as many months, proving the company is willing to splash the cash for desirable assets.This morning’s deal sees GSK pay $950 million cash for Canadian biotech 35Pharma. The real prize is HS235, a protein-based therapeutic that has already completed a phase 1 study in healthy volunteers and is poised to enter trials in patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension due to heart failure with preserved ejection fraction. Like Merck & Co.’s PAH drug Winrevair—which brought in $1.4 billion last year—HS235 targets the activin receptor signaling pathway. However, GSK is hoping that its newly acquired asset will have the edge over Merck’s blockbuster by demonstrating it can also lower the risk of bleeding, improve insulin sensitivity and help patients lose weight while maintaining lean mass.This is because HS235 is designed with enhanced selectivity in order to reduce binding to BMP9 and BMP10—ligands that are associated with adverse events like bleeding and broken blood vessels. Despite current PAH treatment options, a “significant proportion” of patients still require concomitant anticoagulant or antiplatelet therapy, GSK noted in its Feb. 25 release.There is already some evidence to back up GSK’s hopes. When 35Pharma outlined its findings from the phase 1 study in December, the Montreal-based biotech noted that the drug produced dose-dependent decreases in visceral fat mass while preserving or increasing lean mass, as well as achieving deep and sustained target engagement. “HS235’s potential protective effects on vascular function, alongside potential benefits on fat-derived markers of metabolism and inflammation [...] offer new development opportunities within our RI&I portfolio to achieve broader coverage across the metabolic, inflammatory, vascular and fibrotic drivers of multiple chronic diseases that affect the lung, liver and kidney,” GSK Chief Scientific Officer Tony Wood, Ph.D., said in the release.This morning’s deal comes a month after GSK paid $2.2 billion for Rapt Therapeutics and its anti-immunoglobulin E (IgE) antibody to protect against food allergy reactions. Only yesterday, the U.K.-based pharma agreed to pay $40 million for a pair of oligonucleotides from China’s Frontier Biotechnologies.The IgE antibody acquired via Rapt targets the same epitope as Novartis and Roche’s Xolair, and a similar strategy of trying to best an existing blockbuster can be seen this morning in HS235’s similarities to Merck’s Winrevair.The flurry of recent deals in recent weeks also backs up the claims earlier this month of CEO Miels—who took over at the start of the year—that one of the company’s major priorities is to “accelerate what we have” in the pharma\'s pipeline and “add to it via smart business development.”“I can\'t stress this enough for us, accelerating R&D is our biggest opportunity to create value as a company,” Miels told journalists on a Feb. 4 earnings call. “Each quarter you\'ll hear more in detail about how we\'re actually going to make this happen.”

GSK will acquire 35Pharma’s lead cardiopulmonary asset, HS235 through this acquisition. Credit: OleksSH / Shutterstock.com. Less than 24 hours after inking a $1bn licensing deal with Frontier BioSciences, GSK has agreed to acquire Canadian biotech company, 35Pharma. In exchange for $950m in cash at closing, GSK will absorb 100% of 35Pharma’s equity, while gaining access to its clinical and investigational new drug (IND)-stage assets for the treatment of cardiopulmonary diseases, heart failure and obesity. The jewel in 35Pharma’s crown is its lead asset, HS235, which is designed to treat pulmonary hypertension (PH). The therapy, which GSK touts as a “potential best-in-class” medicine in this indication, has already been investigated in a Phase I trial in healthy volunteers who are overweight or with obesity (NCT06714825). HS235 acts by selectively inhibiting activins and growth differentiation factors (GDFs) associated with PH pathology – employing a similar mechanism to MSD’s blockbuster PH therapy, Winrevair (sotatercept). Potentially building on Winrevair’s safety profile, which includes a label warning for severe bleeding events, HS235 is designed to reduce binding to bone morphogenetic proteins 9 and 10 (BMP9 and 10) – both of which have been seen to drive negative treatment effects like bleeding and blood vessel breakage. According to GSK, HS235’s enhanced selectivity could address current PH treatment limitations. Alongside HS235’s possible safety perks, GSK’s CSO, Tony Wood, also touted the drug’s potential to offer “metabolic benefits clinically relevant to PH patients”, ranging from fat-driven weight loss, preservation of lean mass and improved insulin sensitivity to reductions in inflammation and fat hormones. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence GSK notes that these factors could improve the drug’s “clinical and commercial value”, as it is currently estimated that 30-40% of patients with PH are reported as obese. Further studies on HS235 in both PH caused by heart failure with preserved ejection fraction (PH-HfpEF) and pulmonary arterial hypertension (PAH) are set to start imminently. GSK will also gain access to HS370, an Activin x GDF trap designed to treat heart failure and obesity. This drug is currently in the IND-enabling stage of development. GSK doubles down on deals GSK’s acquisition of 35Pharma rides closely on the coattails of several deals the company has made to bolster its therapeutic pipeline – including a $1bn, silent interfering RNA (siRNA)-focused licensing agreement with Frontier BioSciences made less than 24 hours beforehand. Alongside these deals, GSK added food allergy candidate, ozureprubart, to its list of investigative assets through its $2.2bn takeover of RAPT Therapeutics . The UK-based pharma has also employed a dealmaking strategy to enhance its artificial intelligence (AI) capabilities in recent times. An example of this is its $50m, five-year collaboration deal with Noetik, in which GSK will harness the latter’s machine learning (ML) technology to develop cancer treatments. This move follows a wider industry trend towards the technology’s use across everything from drug development to manufacturing and clinical trial operations. GSK’s dealmaking spree comes as the company looks to offset the impact of upcoming patent expiries within its portfolio.