#China #Shanghai #Delonix Bioworks #MenB Vaccine #DX-104

Delonix Bioworks Achieves Landmark IND Clearance for DX-104

In a significant breakthrough for the field of biotechnology, Delonix Bioworks has announced that its investigational MenB vaccine candidate, DX-104, has received Investigational New Drug (IND) clearance from China's National Medical Products Administration (NMPA). This development follows the prior approval from ethics committees in Australia, allowing the company to commence its Phase I clinical trials soon.

Invasive meningococcal disease (IMD) represents a critical threat, particularly for infants, adolescents, and young adults. Meningococcal serogroup B (MenB) has been increasingly prevalent, accounting for about half of the cases globally. While vaccines like GSK's Bexsero® and Pfizer's Trumenba® have set precedents for MenB prevention, a notable gap persists in global accessibility and strain coverage. The launch of DX-104 is poised to address these critical needs.

DX-104 has been developed utilizing Delonix's proprietary OMV Plus® platform. This innovative approach employs engineered outer membrane vesicles (OMVs) that have intrinsic adjuvant properties, which enhances immunogenic responses without the necessity for external boosting agents. Preclinical trials have demonstrated that DX-104 can induce strong serum bactericidal antibody (SBA) responses effectively and consistently, highlighting its potential as a new standard for MenB vaccination.

Furthermore, Delonix has successfully attained commercial-scale production of the vaccine with impressive batch-to-batch reliability, ensuring a sustainable and dependable supply chain as they move towards potential market introduction. This achievement reinforces the feasibility of producing a highly effective and accessible vaccine on a global scale.

Qiubin Lin, the CEO and Founder of Delonix Bioworks, expressed enthusiasm about these advancements, stating, "The dual regulatory clearances in China and Australia mark a transformative milestone for Delonix Bioworks as we transition into a clinical-stage company. This is a crucial step in our global strategy to deploy engineered bacterial vaccines that are designed to be highly immunogenic, well-tolerated, and scalable. We are committed to addressing the urgent unmet medical needs of patients worldwide."

As an emerging leader in the biotechnology sector, Delonix Bioworks is at the forefront of developing next-generation vaccines. Their ongoing projects not only include the MenB vaccine but also focus on other critical infectious diseases, demonstrating a commitment to innovation in vaccine development.

In summary, the IND clearance for DX-104 is a promising step in combatting meningococcal B infections, paving the way for clinical trials that could ultimately lead to a new solution for an urgent public health challenge. Delonix continues to advance its mission of combatting infectious diseases and enhancing public health through effective, engineered vaccines. For further information, you can check their official site at Delonix Bioworks.