Korean CDMO Samsung Biologics will develop and provide manufacturing services to support IND filing for Kineta’s anti-VISTA antibody candidate.
Contract development manufacturing organization (CDMO) Samsung Biologics has signed a partnership agreement to provide end-to-end services for Kineta’s anti-V-domain immunoglobulin suppressor of T cell activation (anti-VISTA) candidate KVA12.1, which aims to treat solid tumors.
Preclinical studies have shown KVA12.1 to have single agent anti-tumor activity and that targeting VISTA along with programmed cell death-1 (PD-1), PD ligand 1 (PD-L1), or cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) increases anti-tumor efficacy.
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“Samsung’s process platform has enabled us to optimally develop the cell line and demonstrate our capabilities to select top clones for robust VCD and higher productivity,” a spokesperson for Samsung Biologics told BioProcess Insider.
“Furthermore, Samsung Biologics is one of the largest CDMOs with various scales when it comes to bioreactor availability for many types of drug substance and drug product production. Kineta chose Samsung Biologics for our antibody development expertise, GMP manufacturing capacity, differentiated flexibility and speed while sustaining high product quality.”
The production cell line will be developed with help from the CDMO’s R&D center in San Francisco and clinical trial materials will be manufactured at the firm’s headquarters in Incheon, South Korea in November.
“For this anti-VISTA project, the molecule will be in 200 L tox material production followed by our process development activities and scale-up to 1,000 L drug substance and drug product manufacturing processes which will be executed for the purpose of IND filing and clinical trial material,” the spokesperson told us.
The firm told us Kineta is expected to file IND submission in Q3, 2022 after drug substance and product manufacturing has been completed in Q1/Q2 of 2022.
“Kineta plans to initiate Phase I clinical trials of KVA12.1 in the second half of 2022,” said the spokesperson.
Samsung Biologics did not disclose any financial details. However, it did confirm Kineta has secured funding for R&D and manufacturing services with the firm as a long-term partner.
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