Kivu Bioscience, a biotech company developing next-generation antibody-drug conjugates, has announced a manufacturing partnership with Sterling Pharma Solutions, a global contract development and manufacturing organisation (CDMO), to produce cGMP-quality material for Phase 1 clinical trials of its lead oncology antibody-drug conjugate (ADC) candidate, KIVU-107.
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Under the agreement, Sterling will manufacture cGMP clinical material for KIVU-107 at its dedicated bioconjugation facility in Deeside, UK. The collaboration includes process familiarisation, analytical development, process optimisation, and scale-up activities in preparation for a cGMP manufacturing campaign.
“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.”
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.
Sterling’s 6,500-square-metre 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, as the second phase of an ongoing strategy to increase the capabilities that it can offer customers.