Antibody-drug conjugate (ADC) developer Kivu Bioscience has chosen CDMO Sterling Pharma Solutions as the designated manufacturer for cGMP-quality material required for Phase I clinical trials of KIVU-107.
Through the agreement, Sterling will be responsible for the manufacture of clinical material for the lead ADC candidate at its dedicated bioconjugation facility in Deeside, UK — which is currently undergoing a £10m expansion to double its manufacturing capacity.
The CDMo will also deal with process familiarisation, analytical development, process optimisation and scale-up activities to prepare for the potential cGMP manufacture of KIVU-107 further down the line.
KIVU-107 is a first-in-class antibody-targeted conjugate that enables site-specific conjugation, making it highly stable, less hydrophobic and more potent that first-gen ADC therapies currently on the market.
“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, President and Chief Operating Officer of 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.”
“Our team at Deeside has extensive experience supporting complex ADC programmes from early development through clinical manufacturing,” said Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions.
“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.”
Sterling's Deeside facilities offers a wide range of ADC services, covering every base from discovery-stage development through to clinical supply.