Kivu Bioscience picks Sterling for cGMP manufacturing of lead ADC candidate

Biotechnology company Kivu Bioscience has announced a partnership with contract development and manufacturing organization Sterling Pharma Solutions to produce cGMP-quality material for Phase 1 clinical trials of Kivu’s lead oncology antibody-drug conjugate (ADC) candidate.

At its bioconjugation facility in Deeside, U.K., Sterling will manufacture cGMP clinical material for KIVU-107, a potential first-in-class ADC which enables site-specific conjugation. The partnership includes process familiarization, analytical development, process optimization, and scale-up activities in preparation for cGMP manufacturing.

“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,” Mohit Trikha, Kivu’s president and COO, said in a statement. “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.”

According to Kivu, KIVU-107’s linker-payload is positioned in a natural cavity in the antibody, which provides stability, reduced hydrophobicity, and an increased therapeutic index relative to first-generation ADCs.

“We’re excited to support Kivu to bring this promising new oncology candidate into the clinic, leveraging our expertise and investment in world-class ADC development and clinical manufacturing capabilities,” Chad Telgenhof, chief commercial officer at Sterling Pharma Solutions, said in a statement.

In October 2024, Sterling announced a £10 million investment at its Deeside site, doubling GMP manufacturing capacity as the second phase of an ongoing capital expenditure strategy. The facility offers a range of ADC services from discovery-stage development through to clinical supply.