SBIR-STTR Award

The proposed program presents a novel approach to the design of a biocompatible, biodegradable, non-toxic, water-soluble nanodelivery system, that allows for the stabilization of proteins and for delivery in a controlled manner. Conflicts in recent world history have seen an influx in the usage of untraditional munitions by groups and nations aiming to press their agendas against the will of the international community. Such parties pose immediate and long-term threats to the defense and security of the American people, thus substantiating the importance of research aimed at the development of a Self-Assembling System for Targeted Nanodelivery of Proteins (STOP) to protect deployed personnel from biological agents, such as anthrax. In the Phase I Base program, STOP development will focus on the preparation and characterization of nanocapsules capable of preserving the activity of antibodies to the protective antigen. The program will focus on developing a method of deposition of the antibodies into the carrier system and determining the release rate and activity of the incorporated antibodies. The Option program will involve scale-up and evaluating the stability of the nanoencapsulated antibodies and the rate of its release in human plasma. (P-040588)

Providing improved countermeasures to protect military personnel and the civilian population from biological warfare agents is an extremely high priority need. For example, there is currently no effective treatment beyond the difficult to control and implement administration of antibiotics shortly after exposure to inhalation anthrax, one of the more likely biological attack scenarios. Although new prophylactic and therapeutic anti-anthrax monoclonal antibody remedies are under accelerated development, none currently provide closely controlled release of the antibody without significant loss of activity. Clearly there is an urgent need for parallel development of new drug delivery technologies that can be preventively administered and released, as needed, to targeted sites. In a recently completed Phase I program Infoscitex and their teaming partner, a university medical center, demonstrated the feasibility of a controlled release drug delivery system. This nano-scaled activity (protein) preserving delivery system is fully water soluble, biodegradable, non-toxic, biocompatible and non-immunogenic. In this proposed Phase II program Infoscitex and its teaming partners will focus on optimizing capacity and control of drug release from the novel protein carrier structure using improved block-copolymer assembly techniques. In vivo testing with anthrax antibody will lead to eventual clinical trials during Phase III.

Keywords:
Needle-Free, Nanodelivery, Biological Warfare Agents, Bioscavenger, Biomacromolecules