Prepared in high yield for industrial purposes, obtained by covalently linking various immunogenic carrier proteins (Tetanus Toxoid, Diphtheria Toxoid, mutant protein CRM197, Outer Membrane Proteins, etc) to Polysaccharides and Oligosaccharides derived from the capsule of Gram-positive and Gram-negative bacteria. Some of these monovalent or polyvalent vaccines of third generation, which have been re-designed with a brand new chemistry for achieving a high-yield quantitative product in the production process, in contrast to the low yields of the so far available conjugation technologies, have as target the prevention in humans (infants, toddlers, children and adults) of diseases like bacterial meningitis and pneumonia due to pathogens like: Neisseria meningitidis Group A, C, W135 and Y, Streptococcus pneumoniae 11 to 18 serotypes, Haemophilus influenzae type b, Staphylococcus aureus, etc. and enteric infections due to pathogens like: Clostridium Difficile, Salmonella typhi, Escherichia coli, etc. The latest valuable BiosYnth's strategy in this field, and particularly addressed to the Polyvalent Pneumococcal Conjugate Vaccine, is the one to synthesize molecular constructs with built-in multiple epitopes carried by a strategically reduced amount of protein carrier in the formulation, and particularly the natural mutant protein CRM197, for consequently improving the safety and the cost of the vaccine.
As vaccines for Gram-negative bacteria and Endotoxin-mediated diseases in humans. Endotoxoid vaccines originate from the BiosYnth's proprietary technology which use conformationally restricted SAEP for selectively binding and saturating the common Lipid A moiety of bacterial LPS antigens, forming a non-toxic high-affinity complex Peptide-LPS. Endotoxoids can also be formulated “ad hoc” as immuno-adjuvants for various bacterial and viral vaccine formulations. Some of these vaccines have as target the prevention in humans of diseases like spinal meningitis, typhoid fever, salmonellosis, shigellosis, cholera and intestinal infections, due to pathogens like: Neisseria meningitidis Group B, Salmonella typhi and paratyphi, Salmonella enterica (serovar enteritidis, typhimurium etc.), Non-typeable Haemophilus influenzae, Vibrio cholerae, Shigella flexneri, Escherichia coli etc. Recently, an Endotoxoid-based vaccine specific for Neisseria meningitidis Group B successfully completed its safety profile in human clinical trial (Phase I) showing the safety of the vaccine and giving the proof of concept for the new implemented principle involving the peptide-based detoxification of bacterial lipopolysaccharide (LPS) antigens.
As new generations of antibiotics and adjuvants for the conventional antibiotic therapy. These synthetic peptides are produced in “bulk” directly by BiosYnth Srl. Some of these new entities, which are very active against highly pathogenic bacteria resistant to conventional antibiotic therapy have as target the most important Gram-negative and Gram-positive bacteria which have shown a significant increase of antibiotic resistance to the conventional antibiotic therapy in the past two decades.