Samsung Biologics San Francisco R&D center and South Korea headquarters will be offering Kineta a seamless, end-to-end CDMO service and their development and manufacturing expertise to advance KVA12.1 to IND.
One of the world’s top Contract Development and Manufacturing Organizations (CDMO), Samsung Biologics, recently inked a strategic partnership agreement with Kineta, Inc. to provide end-to-end CDMO service from cell line development, clinical drug substance, and drug product manufacturing services to support IND filing for KVA12.1.
KVA12.1 is a novel anti-VISTA antibody in development for the treatment of solid tumors, developed by Kineta, a clinical-stage biotech company developing novel immunotherapies in oncology. VISTA is a key driver of the immunosuppressive tumor microenvironment (TME) and is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint, and VISTA blockade can reprogram suppressive myeloid cells and reactivate anti-tumor immune function. Preclinical studies demonstrate single agent anti-tumor activity with KVA12.1, and also demonstrate that targeting VISTA in combination with PD-1, PD-L1 or CTLA-4 can significantly improve the anti-tumor efficacy of those checkpoint inhibitors. Kineta’s KVA12.1 aims to reprogram the TME in hard-to-treat solid tumors.
Samsung Biologics’ R&D Center in San Francisco will be supporting the development of the manufacturing cell line, while its corresponding clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.
Both companies are thrilled to be working together to scale up drug product manufacturing of Kineta’s VISTA immunotherapy and accelerate its introduction to market.
Bringing quality-driven development services at a greater speed, Samsung Biologics delivers cell line development to drug substance manufacturing in six months, and to drug product manufacturing in seven months, the fastest pace in the industry. Currently building its fourth and largest facility in Incheon, Korea, Samsung Biologics will have 620,000 liters of biomanufacturing capacity upon completion of the plant in 2023.