Novel conjugation technology promises faster vaccine development
Biotech firms VALANX Biotech and Fina Biosolutions have announced a collaborative agreement to commercialise ClickCRM, an engineered version of the carrier protein CRM197 designed to accelerate conjugate vaccine development. The partnership, announced on 29 October 2024, combines VALANX’s expertise in site-specific protein conjugation with FinaBio’s established presence in conjugate vaccine development.
Technical advances in carrier protein design
The innovation centres on modifications to CRM197, a widely used antigenic carrier protein crucial for conjugate vaccine production. Through synthetic biology techniques, the collaborators have engineered specific conjugation sites within the CRM197 molecule by incorporating synthetic amino acids. These modifications are compatible with third-generation click chemistry, enabling precise control over the conjugation process between the carrier protein and polysaccharide antigens.
The agreement outlines a clear division of responsibilities between the two firms. VALANX will handle the upstream production, incorporating their proprietary synthetic amino acid technology, whilst FinaBio will manage downstream processing, including purification and formulation. The latter will also take responsibility for marketing and commercialisation of the product.
Implications for vaccine development
The development holds particular significance for bacterial vaccines, where conjugate formulations have demonstrated superior efficacy compared to traditional polysaccharide vaccines. Notable examples include vaccines against pneumococcal and meningococcal infections, where protein-polysaccharide conjugation enhances immunogenicity. Michael Lukesch, Founder and CEO at VALANX Biotech, emphasised the broader implications: “The development of ClickCRM demonstrates the functionality of our platform technology for accurate site-specific protein modification, whether for vaccines or therapeutics. Combining our platform technology with FinaBio’s proprietary, patented method for expressing and purifying CRM197 allows us to achieve high protein expression levels and excellent incorporation of our non-natural amino acid.”
Regulatory considerations
FinaBio’s CEO Andrew Lees highlighted the regulatory advantages of the new technology: “By allowing precise, defined conjugation, ClickCRM will meet current quality expectations of regulatory agencies. It is a welcomed addition to our other carrier proteins, including EcoCRM (CRM197).”
The collaboration represents a significant advancement in conjugate vaccine manufacturing technology, potentially streamlining the development process whilst maintaining rigorous quality standards. The product is now available through FinaBio’s existing distribution channels, alongside their current portfolio of research and GMP-grade carrier proteins.
The partnership’s intellectual property arrangement specifies joint ownership of the associated IP, reflecting the collaborative nature of the development process and suggesting potential for further technical innovations in this field.
