Axplora has produced its first research and development batches of Axotecan, a project to establish a European source of exatecan for companies developing antibody-drug conjugates, or ADCs. The company said gram-scale quantities are available.
Exatecan is a highly potent topoisomerase I inhibitor used as a starting material for certain ADC payloads. Axplora plans to produce validation batches by the end of 2026, conduct registration activities in 2027 and begin supplying material made under good manufacturing practice standards in late 2027, subject to technical, quality and regulatory milestones.
The project combines two Axplora businesses. Farmabios is responsible for highly potent compound development and manufacturing at Gropello Cairoli, Italy. Novasep CDMO provides payload-linker manufacturing and bioconjugation capabilities at the company’s site in Le Mans, France.
At Gropello Cairoli, Axplora operates five manufacturing lines for highly potent active pharmaceutical ingredients, with batch sizes ranging from 0.5 to 300 kilograms. The Le Mans site handles processes used to turn payload materials into ADC drug substance.
Axplora said connecting the sites would give ADC developers a route from exatecan production through payload-linker manufacturing and bioconjugation within one organization. The company is discussing material specifications, anticipated volumes and manufacturing integration with developers as the project progresses.
Axplora also includes PharmaZell, a small-molecule active pharmaceutical ingredient business. Its manufacturing services span small-molecule ingredients, highly potent compounds and ADCs.
The Axotecan work is at the development stage. Its planned transition to validated batches and GMP supply depends on completing the stated milestones.