AGC Biologics, a global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced a new partnership with Evax, a developer of equine vaccines to treat chronic diseases, respiratory disorders and allergies.
 
Through this partnership, Evax advances its Antigen VLP Conjugate product into the clinical stage, and AGC Biologics will supply cGMP support for the pivotal studies. 
 
AGC Biologics is providing services at its Heidelberg facility using microbial-based protein biologics systems. The project covers Process Development and Clinical Manufacturing for the Evax Antigen-VLP Conjugate product.
 
The Evax drug candidate is focused on treating summer eczema, also called sweet itch or insect bite hypersensitivity (IBH), which is one of the most prevalent allergic skin diseases in horses. It manifests as chronic relapsing seasonal allergic dermatitis (inflammatory reaction of the skin).
 
“For many equine diseases only limited therapeutic treatment options are available with sometimes poor efficacy,” said Dr. Antonia Gabriel, CEO and founder of Evax. “We believe in this product and are ready to display its abilities in the clinical stages. Further, AGC Biologics and the capabilities at its Heidelberg site are an ideal fit to help guide us through this important phase of the journey.”
 
AGC Biologics’ Heidelberg facility has more than 20 years of experience delivering a wide range of microbial programs for developers at various stages. To date, it has supported over 100 different microbial processes for different projects, and produced two commercial products. In addition, the site is the CDMO’s Center of Excellence for Plasmid DNA (pDNA) and messenger RNA (mRNA) production, playing a vital role in the company’s global Cell and Gene Therapy services offering. 
 
“The specialized work that Evax is performing for the equine market is truly unique and we are happy to be supporting this important program,” said JB Agnus, chief business officer of AGC Biologics. “This partnership shows the true depth of our services. Thanks to our strong global network, we feel we can support any clinical and commercial projects with reliable, innovative and cost competitive solutions.”
 
AGC Biologics’ microbial services use various technologies and scales, and the CDMO has successfully expressed antibody fragments, growth factors, antigens, enzymes, virus-like-particles (VLPs), and other proteins. The company has experience with E. coli and Pichia microbial expression platforms, and it uses multiple modes of expression—including secretion (yeast), periplasmic secretion, soluble intracellular expression, and inclusion bodies.