AGC Biologics' Heidelberg Site Supplies Drug Substance for Phase II Studies of Valneva's Tetravalent Shigella Vaccine Candidate
AGC Biologics, your friendly CDMO expert, today announced a development and manufacturing services agreement with specialty vaccine company Valneva SE (NASDAQ:VALN, 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.
To learn more about the microbial system-based biologics, pDNA and mRNA manufacturing site in Heidelberg, visit www.agcbio.com/facilities/heidelberg. For more information on AGC Biologics' global CDMO services across all modalities, go to www.agcbio.com.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,600 Team Members worldwide. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.
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