Itepekimab

iStock, Afry Harvy Sanofi and Regeneron have had a long and “sometimes contentious” partnership, BMO Capital Markets noted, as the companies contend with the looming loss of exclusivity of their blockbuster drug Dupixent. As key patent expiries loom over immunology juggernaut Dupixent, Sanofi and Regeneron have renewed their long-term partnership, with the French pharma fronting $1 billion to advance four long-acting, next-generation antibodies for immune-mediated conditions. Sanofi is offering Regeneron up to $7 billion more in development, regulatory and commercial milestones, according to a Thursday morning announcement . The French pharma will co-develop and co-commercialize four Regeneron-discovered antibodies. “Today’s agreement extends a productive (but at some points contentious) partnership,” BMO Capital Markets wrote on Thursday morning. Just last year, Regeneron sued Sanofi , alleging that the French pharma didn’t provide “full access to material information” about Dupixent’s sales. Sanofi has also resisted efforts by Regeneron to audit records related to the blockbuster drug. The companies have settled this dispute, according to their Thursday announcement. The slate of experimental therapies in the renewed partnership is led by the IL-13-targeting REGN20423, which is currently in Phase 1 development for atopic dermatitis. The three other assets are preclinical and include an IL-4xIL-13 bispecific, an anti-IL-4 therapy and a molecule designed to target IL-4R-alpha. All three are expected to enter human studies next year, according to the companies. Legal Regeneron Sues Sanofi, Alleging Stonewalling in Dupixent Pact According to the lawsuit, Sanofi has failed to provide partner Regeneron adequate information regarding the sales of Dupixent—including agreements with payers and pharmacy benefit managers that determine pricing and rebates for the drug. February 7, 2025 · 2 min read · Tristan Manalac Read more The deal could expand beyond these four therapies, as well. Regeneron has the option to include Sanofi’s TSLPxIL-13 bispecific lunsekimig into the alliance—a right that Regeneron can choose to exercise once the molecule clears Phase 3 testing for chronic obstructive pulmonary disease (COPD). Profits for these assets, if they reach the market, will be split 50-50. Lunsekimig is in a pair of Phase 3 trials for COPD, both of which are expected to have initial readouts in 2029. Sanofi is also developing lunsekimig for asthma and chronic rhinosinusitis with nasal polyps, for which it cleared respective mid-stage studies in April. Lunsekimig was also being studied in atopic dermatitis but missed the primary endpoint of improving disease severity in the exploratory Phase 2b VELVET trial. The renewed deal positions “both companies for continued leadership in the development of the next generation of therapeutics for type 2 inflammation-driven disease,” BMO added. Sanofi and Regeneron are expanding their decades-long alliance amid exclusivity concerns for Dupixent. The drug surged 26% last year to bring in $17.8 billion worldwide. But a key U.S. patent is set to expire in 2031 , which could open the blockbuster up to biosimilar challenge and, in turn, erode revenue. Sanofi general counsel Roy Papatheodorou explained during the company’s first quarter call in April that Dupixent has a web of patents extending as far as 2045. Still, the pharma has been working diligently to find a successor. Earnings Sanofi defends Dupixent patents, but execs insist it has nothing to do with CEO change Sanofi’s interim leadership sought on a Thursday earnings call to quell concerns that its sudden defense of Dupixent’s patents had anything to do with the departure of CEO Paul Hudson. April 23, 2026 · 3 min read · Annalee Armstrong Read more Sanofi had pinned a lot of hopes on the autoimmune asset amlitelimab, which came from the $1.4 billion acquisition of Kymab and had been under development for atopic dermatitis and celiac disease. Sanofi in July ended the asset’s development in atopic dermatitis , noting that “the totality of efficacy and safety evidence generated to date does not support further development” in this indication. Similarly being set up as a potential heir to Dupixent was the investigational IL-33 inhibitor itepekimab. Sanofi decided to axe the asset in July following mixed data in a late-stage study for COPD. Amlitelimab and itepekimab no longer appear on the pharma’s pipeline page . Sanofi and Regeneron split Dupixent’s U.S. earnings 50-50, while international profits are divvied up based on a pre-determined sliding scale that gives a slight edge to Sanofi, according to a 2007 agreement between the companies. Thursday’s agreement will not affect the current profit-sharing arrangement for Dupixent, the partners said.

AstraZeneca has unveiled detailed results from two Phase III trials of tozorakimab in chronic obstructive pulmonary disease (COPD) showing that the IL-33 antibody reduced moderate-to-severe exacerbations by about 30% in both."Today's…results, from two replicate trials, set a new standard for COPD treatment outcomes in a broad population of patients," stated Sharon Barr, the company's EVP of BioPharmaceuticals R&D.Toplined in March, results from the OBERON and TITANIA trials, published Tuesday in NEJM and presented at the European Respiratory Society (ERS) meeting, showed the antibody worked across current and former smokers and a range of blood eosinophil counts, as well as all stages of lung function severity.The studies, which included over 1700 participants combined, tested tozorakimab in patients with persistent COPD exacerbations despite inhaled standard of care. They were randomised to tozorakimab 300 mg or placebo once every four weeks, on top of background therapy.IL-33's mixed recordIn OBERON, the primary endpoint was met with a 29% reduction in annualised rate of moderate-to-severe exacerbations among former smokers, while the reduction was 34% in TITANIA. In the overall population involving both current and former smokers, the corresponding reductions were 30% and 29% in the two studies, respectively.The detailed readouts stand out against a backdrop of previous mixed findings with other drugs targeting the IL-33 pathway (see – KOL Views Q&A: AstraZeneca's IL-33 could expand the reach of biologics in COPD).Sanofi and Regeneron's IL-33 antibody itepekimab yielded split results in the Phase III AERIFY-1 and AERIFY-2 trials last year, as did Roche's astegolimab — which targets ST2, a receptor for IL-33 — succeeding in the Phase IIb ALIENTO study, but falling short in the Phase III ARNASA trial (see – KOL Views Q&A: Itepekimab setback more instructive than destructive for IL-33 therapies in COPD and Spotlight On: Roche further muddies water with more "mixed" messages about IL-33 in COPD).Meanwhile, eosinophil counts appeared to influence the magnitude of tozorakimab's benefit. In a pooled analysis of OBERON and TITANIA, exacerbations fell by 43% among patients with baseline blood eosinophils of at least 300 cells/µL, compared to 23% among those below 150 cells/µL. Patients at or above 150 achieved a 34% reduction.Additionally, AstraZeneca said a separate integrated analysis of the two studies presented at ERS found that tozorakimab also reduced mucus plugging, an emerging COPD measure associated with worse disease outcomes.'Rare' fatal eventsThe drug was generally well tolerated, with the only adverse drug reaction being injection-site reactions. The safety analysis did show that while fatal serious adverse events were similar in OBERON between the tozorakimab and placebo arms (1.3% vs 1.2%), they were more frequent with tozorakimab in TITANIA (2.5% vs 0.9%, respectively)."Although these events were rare, the incidence was similar among patients who received tozorakimab every 4 weeks and those who received tozorakimab every 8 weeks," the study authors wrote. "No patterns in adjudicated components of major adverse cardiovascular events, adjudicated causes of death, or in preferred terms for serious adverse events with the outcome of death were apparent."In April, AstraZeneca reported that tozorakimab had succeeded in the Phase III MIRANDA trial in COPD as well.The FDA has accepted AstraZeneca's filing of tozorakimab for priority review as an add-on maintenance treatment for adults with COPD. A decision is expected in the first quarter of 2027, while regulatory reviews are also underway in Europe and China.Tozorakimab is also being tested in a Phase II trial for severe asthma and in a Phase III trial in severe viral lower respiratory tract disease.