Kivu Bioscience Partners with Sterling Pharma for Phase 1 Manufacturing of Next-Generation ADC KIVU-107
核心洞察
Kivu Bioscience (搜索) has selected Sterling Pharma Solutions (搜索) to manufacture cGMP clinical material for its lead oncology (搜索) ADC candidate KIVU-107 (搜索) ahead of Phase 1 trials.
KIVU-107 (搜索) is described as a potential first-in-class antibody-drug conjugate featuring site-specific conjugation technology that positions the linker-payload in a natural antibody cavity.
The partnership leverages Sterling's dedicated bioconjugation facility in Deeside, UK, which recently received a £10 million investment to double its GMP manufacturing capacity.
Kivu Bioscience (搜索) announced a strategic manufacturing partnership with Sterling Pharma Solutions (搜索) to produce cGMP-quality material for Phase 1 clinical trials of its lead oncology (搜索) antibody-drug conjugate candidate, KIVU-107 (搜索). The collaboration positions the San Francisco-based biotech company to advance its next-generation ADC therapy toward first-in-human studies.
Manufacturing Partnership Details
Under the agreement, Sterling will manufacture cGMP clinical material for KIVU-107 (搜索) at its dedicated bioconjugation facility in Deeside, UK. The comprehensive collaboration encompasses process familiarisation, analytical development, process optimisation, and scale-up activities in preparation for the 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 of Kivu Bioscience (搜索). "This partnership marks an important milestone as we advance KIVU-107 (搜索) toward first-in-human studies and deliver on our mission to bring kinder, gentler and efficacious next-generation ADC therapies to patients."
KIVU-107's Innovative Design
KIVU-107 (搜索) represents a potential first-in-class antibody-targeted conjugate that enables site-specific conjugation. The drug's distinctive architecture positions the linker-payload within a natural cavity in the antibody, delivering several therapeutic advantages over conventional ADC approaches. This structural design provides excellent stability, reduced hydrophobicity, and an increased therapeutic index relative to first-generation ADC therapies.
The innovative conjugation approach addresses key limitations of earlier ADC technologies, potentially offering improved safety profiles and enhanced efficacy for cancer (搜索) patients.
Sterling's ADC Manufacturing Capabilities
Sterling's 6,500-square-metre Deeside facility offers comprehensive ADC services spanning from discovery-stage development through clinical supply. The site recently benefited from significant capacity expansion, with Sterling announcing a £10 million investment in October 2024 to double its GMP manufacturing capacity as part of an ongoing strategy to enhance customer capabilities.
"Our team at Deeside has extensive experience supporting complex ADC programs from early development through clinical manufacturing," said Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions (搜索). "We're excited to support Kivu to bring this promising new oncology (搜索) candidate into the clinic, leveraging our expertise and investment in world-class ADC development and clinical manufacturing capabilities."
Company Backgrounds
Kivu Bioscience (搜索) focuses on pioneering next-generation antibody-drug conjugates in oncology (搜索), utilizing proprietary linker-payload technology designed to enhance safety and efficacy while minimizing off-target effects. The company maintains multiple ADC programs in development and is led by a team of industry veterans as it advances lead candidates toward clinical trials.
Sterling Pharma Solutions (搜索) operates as a global contract development and manufacturing organisation with over 50 years of experience in pharmaceutical API development and manufacturing services. The company specializes in handling challenging chemistries and manages complex API challenges from proof-of-concept through commercial manufacture, alongside antibody-drug conjugate research and development bioconjugation services. Sterling employs more than 1,350 people across six facilities in the UK, Ireland, and the United States.