Samsung Biologics and Kineta have entered into a strategic partnership for pharmaceutical manufacturing services and to support an IND filing of a novel therapeutic antibody.
On July 20, 2021, Samsung Biologics announced the signing of a strategic partnership agreement with Kineta, a clinical-stage biotechnology company developing novel immunotherapies, under which Samsung Biologics will provide contract development and organization services for end-to-end manufacturing (CDMO). to Kineta, including cell line development, clinical drug substance, and drug manufacturing services, to support an Investigational New Drug (IND) dossier for KVA12.1, the novel anti-domain V immunoglobulin suppressor of Kineta for T cell activation (anti-VISTA) antibody developing 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. In addition, the 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 immune checkpoint of myeloid cells and blocking VISTA can reprogram myeloid suppressor cells and reactivate anti-tumor immune function. Preclinical studies demonstrate antitumor activity as monotherapy with KVA12.1. In addition, targeting of VISTA in combination with programmed cell death-1 (PD-1), PD 1 ligand (PD-L1) or cytotoxic T-lymphocyte-associated antigen 4 (CTLA- 4) Significantly improves the antitumor action the effectiveness of these checkpoint inhibitors. Kineta’s KVA12.1 aims to reprogram TME in hard-to-treat solid tumors.
“We are very pleased to partner with Kineta to support the commercialization of this cancer immunotherapy,” said John Rim, CEO of Samsung Biologics, in a company press release. “We will make full use of our capabilities and streamlined end-to-end processes from our head office 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 move KVA12.1 to IND and into early human clinical trials next year,” said Shawn Iadonato, PhD, CEO de Kineta, in the press release. “We are delighted to be working with Samsung to launch and scale up drug manufacturing for our VISTA immunotherapy.”
Source: Samsung Biologics