AGC Biologics, your friendly CDMO expert, announced a development and manufacturing services agreement with specialty vaccine company Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) 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 (CHIM) in November 2024.

Shigellosis is the second leading cause of fatal diarrheal disease worldwide, strongly contributing to pediatric morbidity and mortality. It is estimated that up to 165 million infections are due to Shigella, of which 62.3 million occur in children younger than five years. Developing an effective vaccine to prevent this deadly disease is a public health imperative for many areas of the world.

"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. "We appreciate Valneva entrusting our team of experts with this challenge and are honored to contribute to efforts that aim to prevent millions of deadly infections in the future."

AGC Biologics runs multiple cGMP microbial fermentation lines at its Heidelberg facility. The site has produced biologics products for 40 years. It offers developers freedom-to-operate strain development, proven experience with different bacterial and yeast systems, proprietary plasmid DNA (pDNA) and messenger RNA (mRNA) platforms, large-scale tanks for late-phase protein refolding, the ability to take on early-phase and fast track projects, and late-phase and commercial expertise.