Cagrilintide

Facing a series of disappointments for its obesity portfolio, Novo Nordisk is likely more motivated than ever to breathe new life into its cardiometabolic pipeline — and it's turning to external sources for that vital refresh. On Wednesday, the Danish drugmaker tapped Vivtex and its AI-powered platform to develop oral biologics for obesity and diabetes. The Boston-based biotech stands to receive up to $2.1 billion across an upfront payment, research funding and milestones, plus tiered royalties. Novo's embrace of Vivtex's oral technology comes as yet another of its injectables was bested by rival Eli Lilly. The pharma's shares fell more than 16% on Monday after disclosing that CagriSema — a fixed-dose injectable that combines Novo's GLP-1 receptor agonist Wegovy (semaglutide) with cagrilintide, a long-acting analogue of the amylin hormone — failed to show non-inferiority versus Lilly's GLP-1/GIP dual agonist Zepbound (tirzepatide) in the Phase III REDEFINE 4 study (see – Spotlight On: What's left for Novo in the obesity race?). With injectable Wegovy having lost its dominant place in the obesity market to Zepbound, the remaining bright spot in Novo's obesity portfolio is the oral formulation of the GLP-1, FDA-approved in December and already seeing impressive uptake (see – Vital Signs: Early energy for oral Wegovy). Oral embraceGiven the early success of the Wegovy pill, Novo seems to be embracing orals as the route by which it will reclaim its weight-loss leadership."Novo Nordisk has long been a leader in peptide therapeutics for metabolic diseases, so they understand both the clinical potential of these medicines and the challenges of delivering them orally," Vivtex CEO Thomas von Erlach told FirstWord. Co-founded by Erlach along with biotech veteran Bob Langer and MIT professor Giovanni Traverso, Vivtex's differentiated — and scalable — approach to oral biologics complements Novo's therapeutic know-how, Erlach said."Dr. Langer has also maintained a long-standing relationship with Novo Nordisk through decades of work in drug delivery and translational science, which has helped foster strong scientific alignment between the teams," he added. Optimising oral delivery with AITo develop oral biologics — an enduring drug development challenge given enzymatic degradation in the digestive tract, poor absorption, and variability in bioavailability — Vivtex is integrating high-throughput screening with predictive AI technologies to optimise both the molecule and its delivery system simultaneously. "Vivtex’s platform is designed specifically to address the core barriers that have historically limited oral biologics," Erlach said. "By combining molecular modeling, AI-enabled design, and large proprietary formulation libraries, we can evaluate how peptide structure, formulation, and delivery interact as an integrated system rather than in isolation." Flexibility is also a key ingredient in Vivtex's oral recipe. The company doesn't rely on a single formulation strategy to create oral biologics — its rapid testing capabilities means that it can refine multiple approaches before selecting the right combination that protects the biologic, enables transport across the intestinal lining, and achieves consistent exposure."This systematic, data-driven process increases the probability of success and shortens the path from concept to clinically viable oral candidates," Erlach said.Vivtex will be responsible for research and formulation selection, after which Novo will take charge of global development, regulatory activities, manufacturing and any commercialisation.