A Complete System for Vaccine Development

The Stealth Microparticle™ technology is a complete innovative vaccine platform technology. Each component of the system (carrier, adjuvant compositions, epitopes) offers significant advantages over present technologies. In addition, the system as an integrated whole brings considerable benefits to vaccine development and commercialization, as follows:

• Equally applicable to any pathogen (human or animal);
• Storage and shipping at ambient temperatures – extended shelf life of product; resulting in improved supply-chain management
• Multiple possible routes of administration – oral, mucosal, IM, IV, etc.;
• A true multi-valent vaccine;
• Concept (indication selection) to pre-clinical animal trials is fast;
• Plug-and play manufacturing that does not involve growing live organisms;
• No viral or other contamination from animals or cell culture media

As a complete system, GalenBio's Stealth Microparticle™ technology represents a new, comprehensive approach to vaccine development. Scientific articles are appearing in the literature about the potential advantages of the multi-epitope approach for vaccines. GalenBio has developed proprietary technologies required to make effective multi-epitope vaccines.

Carrier

Incorporation of multiple antigens and adjuvant molecules into the same particle can be a tedious task with conventional carriers, as these molecules usually do not precipitate under the same conditions.

The GalenBio Stealth Microparticle™ is made of natural polysaccharide polymers, with demonstrated excellent biocompatibility and biodegradability. This chemistry allows the immobilization of several antigens along with different combinations of Pattern Recognition Receptor (PRR) agonists and other adjuvant molecules in a controlled and highly reproducible fashion on the surface of the microparticle. This linkage between the antigen and the particles assures that the same antigen-processing cells take up both the PRR agonists and the antigen. The immobilization chemistries have been validated for multiple ligands so manufacturing and formulation is easy and standardized. It has been demonstrated that GalenBio’s Stealth Microparticles™ are efficient in mucosal vaccinations.

Adjuvant

GalenBio has proprietary combinations of multiple PRR agonist and other adjuvant molecules. Using such a combination, the immune response can be potentially increased up to 100-fold over a single adjuvant molecule alone. This not only reduces the cost of vaccines and innate immune enhancers, but also reduces potential side-effects seen with use of single toll-like receptor (TLR) agonists. Immobilization of the PRR agonist to the microparticle offers additional benefits, such as stabilization of the PRR agonist molecules and improved presentation to the immune system.

Single TLR/PRR agonists have shown great promise in vaccine development and as adjunct therapies in cancer, allergic and infectious diseases. However, problems such as instability and side-effects related to the relatively high dose required have already surfaced. GalenBio’s proprietary position in the combination of PRR agonist and other adjuvant molecules is critical in the further development of these therapies.

Antigen

GalenBio scientists have developed proprietary epitope biopanning methods along with computer algorithms to select the protective epitopes that are critical part of an effective vaccine. Immune escape of the pathogens is an important part in establishing chronic infections. Proprietary algorithms allow the identification of escape epitopes, so they can be excluded from the vaccine formulation, leading to great improvement in vaccine efficacy. In addition, GalenBio has developed proprietary methods to identify protective epitopes vaccine.

Systems approach

GalenBio has streamlined vaccine development and manufacturing. The vaccine components are manufactured using already proven, scalable and cGMP compliant technologies. GalenBio has over 20 years’ experience with the cGMP-compliant manufacture of carrier and immobilizations employed for the epitopes and adjuvant molecules as described above. The key message in this “systems approach” is that the components of every vaccine, and the assembly of those components into a working vaccine, are the same, no matter what type of vaccine one is designing. This plug-and-play manufacturing approach moves more products more quickly into the market. GalenBio’s manufacturing system offers significant advantages over egg-based or cell culture-based vaccine production, both in terms of productivity and cost.