- AGC Biologics has signed a development and manufacturing agreement with Valneva SE to supply drug substance for a four-valent Shigella vaccine candidate.
- The contract manufacturing work will be conducted at AGC Biologics’ Heidelberg site to support Phase 2 clinical supply.
AGC Biologics has announced a new agreement with Valneva SE to provide development and manufacturing services for a four-valent Shigella bioconjugate vaccine candidate. The work will be carried out at the CDMO’s facility in Heidelberg, Germany.
The investigational vaccine, which targets Shigellosis—a major global cause of fatal diarrheal disease—was exclusively licensed by Valneva from LimmaTech Biologics AG. LimmaTech had previously collaborated with AGC Biologics to establish GMP-compliant processes for the vaccine’s complex protein-polysaccharide conjugates during early clinical development.
Under the new agreement, AGC Biologics will support Phase 2 clinical supply. This includes a Phase 2 infant study that began in April and a planned Phase 2b Human Challenge Study set for November 2024. The Heidelberg facility is equipped to guide complex molecules through the clinical pipeline and has extensive experience in microbial fermentation.
Shigellosis causes an estimated 165 million infections each year, with 62.3 million cases occurring in children under five. The disease presents a critical public health challenge, especially in low-resource settings.
“Our site’s unique ability to handle complex molecules and multi-valent assets can help this potentially life-saving program reach its next clinical milestone,” said Dieter Kramer, Senior Vice President and General Manager, AGC Biologics Heidelberg.
The Heidelberg site offers multiple cGMP microbial fermentation lines and has a 40-year history in biologics manufacturing. Its capabilities include proprietary plasmid DNA and mRNA platforms, large-scale protein refolding, and support for both early- and late-phase contract manufacturing projects.
