US20260097114
2026-04-09
Human necessities
A61K39/215
The patent application describes a novel platform conjugation technology for the production of highly immunogenic conjugate vaccines. These vaccines are designed to provide broad cross-neutralization against variants of concern (VOC) and are manufactured more cost-effectively compared to mRNA vaccines. By utilizing protein-protein conjugates and Toll-Like Receptor (TLR) agonist adjuvants, the vaccines enhance immunogenicity and offer broad cross-protection, addressing limitations seen in early mRNA COVID-19 vaccines. The invention demonstrates equivalent neutralizing antibody titers across multiple variants, showcasing its potential for long-lasting protection without the need for frequent boosters.
The invention addresses the need for affordable and broadly protective vaccines, especially in Low-and Middle-Income Countries (LMIC). The rapid deployment of COVID-19 vaccines significantly reduced mortality rates, but vaccine inequity left many regions vulnerable. The first-generation mRNA vaccines, while quickly produced, required frequent boosters due to waning effectiveness. The invention aims to provide durable protection against evolving strains of SARS-CoV-2 by utilizing stabilized prefusion spike proteins as the primary antigen, ensuring proper immunogenic recognition and response.
The method involves expressing an antigen from an RNA sequence in a cell line, followed by conjugation with carrier proteins or adjuvants to form an immunogenic composition. The carrier proteins can include a variety of toxoids and viral proteins, while adjuvants may consist of aluminum salts or TLR agonists. This approach not only enhances the immune response but also allows for rapid adaptation to new pathogens, facilitated by the use of stable CHO cell pools that can be generated quickly and affordably.
The invention provides a method for producing vaccines that are both effective and economical, crucial for addressing global health disparities. It offers a solution to the high costs and limited protection of current vaccine strategies by enabling the rapid development of vaccines against emerging variants. The use of pooled cell populations in early clinical phases accelerates the approval process, potentially leading to quicker access to vaccines in high-need areas.
Experiments demonstrated the effectiveness of the vaccine candidates in eliciting strong immune responses in animal models. Figures included in the application show the induction time course of protein expression, the impact of conjugation and adjuvants on immune responses, and the binding titers of antibodies against different SARS-CoV-2 variants. Statistical analysis confirms the significance of the results, supporting the potential of the invention to provide robust and long-lasting protection against COVID-19 and its variants.