BiosYnth s.r.l.

BiosYnth has developed a proprietary 3rd Generation Glycoconjugate Vaccine Platform for the development and industrial manufacturing of next-generation bacterial vaccines. The platform employs a proprietary high-yield conjugation technology that covalently links bacterial polysaccharides and synthetic oligosaccharides to clinically validated carrier proteins, including CRM197 and Tetanus Toxoid (TT). Compared with conventional conjugation technologies, the platform delivers higher manufacturing yields, improved scalability, optimized carrier protein utilization and lower production costs, enabling safer and more cost-effective mono- and multivalent vaccines. The platform has generated a diversified glycoconjugate vaccine pipeline across three major therapeutic areas: Invasive Pneumococcal Disease (IPD), Invasive Meningococcal Disease (IMD) and Multidrug-Resistant (MDR) bacterial infections. The most advanced programs are the 13-valent Pneumococcal Conjugate Vaccine (PCV13) and the Quadrivalent Meningococcal Conjugate Vaccine (MenACWY), both developed in collaboration with strategic partners and currently awaiting Marketing Authorization in China. Additional programs include the 20+ valent Pneumococcal Conjugate Vaccine, and the new Group B Nanostructured Endotoxoid Vaccine in single formulation as well as in the new combined Pentavalent formulation. BiosYnth is seeking strategic investment to accelerate the international commercialization of its lead glycoconjugate vaccines. The investment will support regulatory development, licensing and commercialization in the Western world, including North America and Europe, while advancing the clinical development of the MenB program and the company's next-generation bacterial vaccine pipeline.

BiosYnth has developed a proprietary Nanostructured Vector System (VS) Platform, a patented antigen delivery technology designed to enhance and immediately boost the immune responses against conformational epitopes of bacterial and viral antigens. The platform is based on a nanostructured endotoxoid vector that mimics the three-dimensional architecture of viral nanoparticles, promoting efficient antigen presentation, immediate helper T-cell activation and durable immune responses. Compatible with proteins, glycoproteins, peptides, glycolipids, lipopolysaccharides and glycoconjugates, the VS Platform provides a versatile technology for the development of next-generation vaccines across multiple pathogens responsible for epidemic and pandemic infectious diseases. The platform has been already successfully experienced in several preclinical studies and validated for safety in Phase 1 human trial. It has generated a diversified vaccine pipeline spanning Bacterial Diseases, Antimicrobial-Resistant (AMR/MDR) Bacterial Diseases and Viral Diseases. Current development programs include Nanostructured Group B Meningococcal Vaccine and Gonorrhea Vaccine together with vaccine candidates targeting Influenza, Respiratory Syncytial Virus (RSV) and SARS-CoV-2. The patented technology also provides a versatile platform for vaccine development against, Escherichia coli, Salmonella Typhi/Paratyphi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter baumannii and Shigella species in addition to viral vaccines targeting a variety of epidemiologically significant end expanding viruses like Dengue virus, Haemorragic Fever Viruses (HFV), HIV virus. BiosYnth is seeking strategic investment to accelerate the clinical development of the VS Platform. The investment will support the advancement of the lead vaccine programs, expansion of the platform across bacterial and viral diseases, strengthening of the intellectual property portfolio, and the establishment of international partnerships for co-development and licensing.

Production and application of synthetic peptides, including cyclic and dimeric structures, for endotoxin neutralization and detoxification in vaccine development and septic shock therapy.

Endotoxin [lipopolysaccharide (LPS)], the major antigen of the outer membrane of Gram-negative bacteria, consists of a variable-size carbohydrate chain that is covalently linked to N,O-acylated β-1,6-D-glucosamine disaccharide 1,4′-bisphosphate (lipid A). The toxic activity of LPS resides in the lipid A structure. The structural features of synthetic peptides that bind to lipid A with high affinity, detoxify LPS in vitro, and prevent LPS-induced cytokine release and lethality in vivo were defined. The binding thermodynamics were comparable to that of an antigen-antibody reaction. Such synthetic peptides may provide a strategy for prophylaxis and treatment of LPS-mediated diseases.**