Valneva signs development, manufacturing agreement with AGC Biologics

AGC Biologics announced a development and manufacturing services agreement with Valneva (VALN) to supply drug substance for an investigational four-valent Shigella bioconjugate vaccine at the CDMO’s Heidelberg facility. Valneva exclusively licensed the vaccine candidate from LimmaTech Biologics AG, which previously worked with AGC Biologics to establish GMP-compliant manufacturing and quality control of the vaccine’s complex protein-polysaccharide conjugates for first-in-human studies. The objective of the new partnership with Valneva is to establish phase II supply relying on the ability of AGC Biologics’ Heidelberg site to guide complex molecules through clinical stages. Valneva and LimmaTech announced the launch of a Phase 2 infant study in April, and a Phase 2b Human Challenge Study in November 2024.