Kivu Bioscience, a biotech company developing next-gen antibody-drug conjugates (ADCs), entered a manufacturing agreement with Sterling Pharma Solutions, a global CDMO, to produce cGMP-quality material for Phase 1 clinical trials of its lead oncology ADC candidate, KIVU-107.

Sterling will manufacture cGMP clinical material for KIVU-107 at its dedicated bioconjugation facility in Deeside, UK. The collaboration includes process familiarization, analytical development, process optimization, and scale-up activities in preparation for a cGMP manufacturing campaign.

KIVU-107 is a potential first-in-class antibody-targeted conjugate which enables site-specific conjugation. The resulting structure positions the linker-payload in a natural cavity in the antibody, providing excellent stability, reduced hydrophobicity, and an increased therapeutic index relative to first-generation ADC therapies.

“We chose Sterling as our manufacturing partner based on their deep expertise in ADC development, proven track record of clinical supply, and commitment to quality,” said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. “This partnership marks an important milestone as we advance KIVU-107 toward first-in-human studies and deliver on our mission to bring kinder, gentler and efficacious next-generation ADC therapies to patients.”

Sterling’s 6,500-square-meter Deeside facility offers a range of ADC services, from discovery-stage development through to clinical supply. In October 2024, Sterling announced a £10 million investment at the site to double its GMP manufacturing capacity.