Guselkumab

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here . Endpoints will be covering #ESMO24 throughout the weekend, so make sure to follow along online. Deputy editor Reynald Castañeda and reporters Kyle LaHucik, Lei Lei Wu and Ayisha Sharma will be reporting from Barcelona. — Max Gelman On Monday, the US House of Representatives passed the Biosecure Act with broad bipartisan support. The bill would force biopharma companies to cut ties or restrict their work with contract manufacturers WuXi AppTec , WuXi Biologics and three genetic sequencing companies by 2032. However, it still faces an uncertain future in the Senate. Opponents have argued that the bill was written to quickly and too broadly. Zachary Brennan has the latest. Biotech’s Covid-19 superstar has faced a rough go of it since the pandemic ended, saying since late last year that it would adopt a more “restrained” approach. But after leading off 2024 with $4 billion in expected cuts, Moderna said this week that it’s planning even more . Executives mapped out an additional $1.1 billion in cuts by 2027 and pushed back the company’s breakeven point by two years, from 2026 to 2028. Moderna’s stock is down more than 80% over the last three years. Our Andrew Dunn also framed how to think about this news in our Post-Hoc newsletter. Our reporters shared updates from #ESMO24, including lackluster data on Amgen’s PRMT5 inhibitor, a Phase 2 look at Jazz’s HER2 antibody, Bicycle’s early case for its Padcev competitor, mid-stage data for GSK and iTeos’ PD-1 and TIGIT doublet , and more. Stay tuned for more conference coverage throughout the weekend. In May, Summit surprised the industry by claiming its PD-1/VEGF bispecific antibody called ivonescimab beat Merck’s Keytruda in a head-to-head Phase 3 study. This Sunday, Summit backed up its case. Ivonescimab reduced the risk of lung cancer progression or death by 49% in the study, with patients going an average of 11.1 months before their disease worsened. Keytruda recorded an average of 5.8 months. Summit’s stock is up more than 800% since the May reveal, and more than 900% for the whole year. Friday afternoon, Jared Whitlock reported that the SEC’s probe of the Illumina-Grail deal is focused on sales forecasts made by Grail’s management in the run-up to the 2021 transaction. In June, Illumina spun off Grail and it began trading as a public company. We covered a string of early-stage GLP-1 readouts this week, including from Roche’s dual GLP-1/GIP candidate which showed promising weight loss, but also high rates of vomiting in a Phase 1b study . Terns also offered an early look at its oral GLP-1 agonist, which it says could be more tolerable at higher doses than currently marketed GLP-1s that are administered the same way. And Zealand’s GLP-1/GLP-2 receptor dual agonist showed promising weight loss after a previous effort with lower doses ended with “underwhelming” efficacy. SPOTLIGHT R&D PHARMA FINANCING FDA DEALS MANUFACTURING HEALTH TECH DON’T MISS

Pictured: J&J’s office in Madrid, Spain iStock, BrasilNut1 Tremfya’s ulcerative colitis approval on Wednesday comes as Johnson & Johnson’s blockbuster immunotherapy Stelara continues to face growing competition from biosimilars. The FDA on Wednesday approved Johnson & Johnson ’s therapeutic antibody Tremfya (guselkumab) for the treatment of adult patients with moderate to severe active ulcerative colitis. According to the pharma, Tremfya is now the first and only fully-human, dual-acting monoclonal antibody for ulcerative colitis (UC). Tremfya not only blocks IL-23 to dampen the inflammatory response but also targets the CD64 receptor on cells that secrete IL-23, such as activated macrophages and monocytes. Christopher Gasink, J&J’s vice president for medical affairs, gastroenterology and autoantibody, in a statement said that the approval gives UC patients a new treatment option that provides “meaningful improvements in symptoms” as well as the “promise of remission.” J&J is also seeking approval for Tremfya in Crohn’s disease. Tremfya is already approved for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis. Backing Wednesday’s approval are findings from the Phase IIb/III QUASAR study, a randomized, double-blinded and parallel-group study that tested 200-mg and 100-mg doses of Tremfya in patients who had previously shown suboptimal response—or were otherwise intolerant to—conventional therapies, including biologics and JAK inhibitors. Results showed that 50% of patients given 200 mg of Tremfya every four weeks achieved clinical remission at 44 weeks, compared with only 19% on placebo. Those who received the lower 100-mg dose every eight weeks had a clinical remission rate of 45%. The treatment effects for both dose groups were statistically superior to placebo, according to J&J. Endoscopic remission at one year was likewise significantly better for the 200-mg and 100-mg Tremfya doses, with respective rates of 34% and 35%, versus 15% in the placebo arm. QUASAR also “reinforced the well-established safety profile” of Tremfya, the company said. The findings continue “to raise the bar for efficacy in the treatment of this inflammatory bowel disease,” according to Gasink. Wednesday’s approval adds to J&J’s efforts to protect its bottom line from growing biosimilar competition for its blockbuster immunotherapy Stelara (ustekinumab). First approved in 2009 for moderate-to-severe plaque psoriasis, Stelara quickly became one of J&J’s top-performing assets, winning additional indications in ulcerative colitis and Crohn’s disease, among others. In 2023, Stelara sales jumped 11.7% year-over-year to $10.9 billion . However, the recent expiration of one of its key patent protections has opened the door to biosimilar competitors to enter the market. In November 2023, Amgen won approval for its interchangeable Stelara copycat Wezlana (ustekinumab-auub) for several inflammatory conditions. Teva and Alvotech followed suit in April 2024 with a regulatory victory for Selarsdi (ustekinumab-aekn), set to launch in early 2025. Compounding J&J’s Stelara challenges is a recent announcement from Cigna’s Evernorth Health Services that it would offer patients an interchangeable biosimilar at $0 out-of-pocket cost starting next year.