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Samsung Biologics and Kineta have entered into a strategic partnership for drug product manufacturing services and to support an IND filing of a novel antibody therapeutic.
On July 20, 2021, Samsung Biologics announced that it has signed a strategic partnership agreement with Kineta, a clinical-stage biotech company developing novel immunotherapies, under which Samsung Biologics will provide end-to-end contract development and manufacturing organization (CDMO) services to Kineta, including cell line development, clinical drug substance, and drug product manufacturing services, to support an investigational new drug (IND) filing for KVA12.1, Kineta’s novel anti-V-domain immunoglobulin suppressor of T cell activation (anti-VISTA) antibody in development for the treatment of solid tumors.
Under the agreement, the manufacturing cell line will be developed with support from Samsung Biologics’ R&D Center in San Francisco. Additionally, corresponding clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.
VISTA is a key driver of the immunosuppressive tumor microenvironment (TME). It has been shown to be overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint and blocking VISTA can reprogram suppressive myeloid cells and reactivate anti-tumor immune function. Preclinical studies demonstrate single agent anti-tumor activity with KVA12.1. Furthermore, targeting VISTA in combination with programmed cell death-1 (PD-1), PD ligand 1 (PD-L1), or cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) was demonstrated to 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.
“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, in a company press release. “We will fully utilize 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, CEO at Kineta, in the press release.“We are excited to collaborate with Samsung to initiate and scale up drug product manufacturing of our VISTA immunotherapy”.
Source: Samsung Biologics