“These papers report the first steps in the execution of our plans to create room temperature stable, orally self-administered, safe and effective vaccines against shigellosis, typhoid fever, anthrax, enterotoxigenic Escherichia coli, and eventually other causes of diarrheal diseases and agents of bioterrorism,” said Dr. B. Kim Lee Sim, President of Protein Potential LLC. “The next step will be to manufacture the vaccines in compliance with current Good Manufacturing Practices and initiate clinical trials to assess the safety, tolerability, immunogenicity, and protective efficacy of these vaccines.”
Professor Johnny W. Peterson of the University of Texas Medical Branch Galveston said, “We were extremely pleased to find that immunization with Ty21a-PA-01 protected rabbits against 200 times the 50% lethal dose of anthrax spores. Since this vaccine was stable at room temperature for 20 months and can be administered orally, it holds great promise for community-wide immunization in the face of an anthrax threat.”
Dr. Richard I. Walker, Director of the Enteric Vaccine Initiative at PATH said, “Shigellosis has emerged as the number one bacterial cause of diarrheal diseases in 1-10 year olds worldwide. An unstable form of Ty21a expressing S. sonnei O antigen was shown to protect volunteers against controlled human infection more than 30 years ago. Protein Potential’s engineering of the acid-stabilized Ty21a, which stably expresses S. sonnei O antigen represents a promising step forward in our quest to finally license a vaccine to prevent shigellosis.”
Protein Potential’s research and development efforts for these anthrax and shigellosis vaccines were funded by SBIR and R01 grants from the National Institute of Allergy and Infectious Diseases, NIH.
About Protein Potential, LLC: Protein Potential’s Research and Development Group focuses on producing intellectual property and recombinant bacteria, recombinant protein, and DNA products. Protein Potential’s primary focus is on development of vaccines to protect against enteric diseases including shigellosis, diarrhea caused by ETEC, and typhoid fever and bioterrorism agents using its platform technology of recombinant, acid-stabilized Ty21a. Protein Potential is also developing subunit vaccines for Plasmodium falciparum and Plasmodium vivax malaria. Protein Potential’s Products and Services Group provides pharmaceutical and biotechnology companies, and government and academic institutions with high quality, purified Protein PotentialTM recombinant proteins and DNA plasmids for research and development. Protein Potential also provides process development, documentation, and technological know-how to transition therapeutic, vaccine, and diagnostic proteins and DNA plasmids to large-scale cGMP (Good Manufacturing Practices) manufacture (Protein PotentialTM service packages).
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SOURCE Protein Potential, LLC