drugset / Press release

Kivu Bioscience Selects Sterling Pharma Solutions for cGMP Manufacturing of Lead Oncology Antibody-Drug Conjugate KIVU-107

2025-06-02 · Kivu Bioscience Inc. · original kivubioscience.com ↗

SAN FRANCISCO–( BUSINESS WIRE )– Kivu Bioscience , a biotech company developing next-generation antibody-drug conjugates, announced today a manufacturing partnership with Sterling Pharma Solutions , a global contract development and manufacturing organisation, to produce cGMP-quality material for Phase 1 clinical trials of its lead oncology antibody-drug conjugate (ADC) candidate, KIVU-107. 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. “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. “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 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. About Kivu Bioscience Kivu Bioscience is pioneering next-generation antibody-drug conjugates (ADCs) in oncology. The company’s proprietary linker-payload technology delivers enhanced safety and efficacy, minimizing off-target effects to improve patient outcomes. With multiple ADC programs in development and a team of industry veterans, Kivu is advancing its lead candidates to clinical trials. The company is headquartered in San Francisco, CA. For more information, visit www.kivubioscience.com . About Sterling Pharma Solutions Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specialising in handling challenging chemistries. Sterling manages the most complex API challenges from proof-of-concept to commercial manufacture, as well as antibody-drug conjugate (ADC) research and development bioconjugation services. Sterling has six facilities employing more than 1,350 people: its HQ in Dudley, Northumberland, UK; a chemistry services business in Newcastle upon Tyne, UK; a site in Ringaskiddy, Co. Cork, Ireland; a dedicated bioconjugation and ADC facility in Deeside, North Wales, UK; and two sites in the US, in Cary, North Carolina and Germantown, Wisconsin. Find out more Contacts Media Kimberly Ha KKH Advisors 917-291-5744 [email protected] Prev Previous With $92M, Kivu sets out to make ‘kinder, gentler’ ADCs Next Kivu Bioscience Presents Preclinical Data for KIVU-107 Demonstrating Potent and Durable Anti-Tumor Activity and a Wide Therapeutic Index at World ADC San Diego 2025 Next 2929 Campus Drive, Suite 420, San Mateo CA 94403 Linkedin Site by BKW © 2026 Kivu Bioscience Manage Consent To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions. 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