Samsung Biologics, a global CDMO, has entered a partnership with Kineta, a clinical-stage biotech company developing novel immunotherapies in oncology. Samsung will provide CDMO service from cell line development, clinical drug substance, and drug product manufacturing services to support IND filing for KVA12.1, Kineta’s anti-VISTA antibody in development for the treatment of solid tumours.
VISTA is a driver of the immunosuppressive tumour 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-tumour immune function. Preclinical studies reportedly demonstrate single agent anti-tumour activity with KVA12.1, and also demonstrate targeting VISTA in combination with PD-1, PD-L1 or CTLA-4 can significantly improve the anti-tumour efficacy of those checkpoint inhibitors. KVA12.1 is designed to reprogram the TME in hard-to-treat solid tumours.
The manufacturing cell line will be developed with support from Samsung Biologics’ R&D centre in San Francisco, and its corresponding clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.
“We are very glad to be partnering with Kineta, to provide support in bringing this cancer immunotherapy to market,” said John Rim, CEO of Samsung Biologics. “We will fully utilise our capabilities and streamlined end-to-end processes from both our headquarters and US R&D Center, to enable high-quality development of KVA12.1 with faster speed to accelerate Kineta’s success.”
“Establishing this strategic partnership with Samsung is a critical step for Kineta as we advance KVA12.1 to IND and into first-in-human clinical trials next year”, said Shawn Iadonato, PhD, Chief Executive Officer at Kineta. “We are excited to collaborate with Samsung to initiate and scale up drug product manufacturing of our VISTA immunotherapy”.