Protein Potential, LLC Publishes on its Anthrax and Shigellosis Vaccines Based on Oral Typhoid Fever Vaccine Platform

ROCKVILLE, Md., June 15, 2017 /PRNewswire-USNewswire/ -- In a report published today in npj Vaccines, "Protection against inhalation anthrax by immunization with Salmonella enterica serovar Typhi Ty21a stably producing protective antigen of Bacillus anthracis," Dr. B. Kim Lee Sim and colleagues from Protein Potential, LLC, Sanaria Inc., the University of Texas Medical Branch Galveston, and the US FDA report that rabbits immunized with Protein Potential's Ty21a-PA-01 vaccine were protected against a lethal aerosolized challenge with anthrax spores. The vaccine, Ty21a-PA-01 is composed of the oral attenuated typhoid fever vaccine, Ty21a, stably expressing the protective antigen (PA) of Bacillus anthracis, the bacterium that causes anthrax. The link to the npj Vaccines article is doi: 10.1038/s41541-017-0018-4.

Earlier this year the Protein Potential team published a paper in the Journal of Infectious Diseases, "Development of a Live Attenuated Bivalent Oral Vaccine Against Shigella sonnei Shigellosis and Typhoid Fever," (link to article is doi: 10.1093/infdis/jiw528) in which Dr. Y. Wu and colleagues from Protein Potential LLC and Sanaria Inc., reported that immunization with Protein Potential's TyOraSs vaccine, composed of an acid-stabilized form of Ty21a, expressing the O antigen of Shigella sonnei, protected mice from lethal Shigella infection.

"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 Potential^TM 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 Potential^TM service packages).

This news release contains certain forward-looking statements that involve known and unknown risks and uncertainties, which may cause actual results to differ materially from anticipated results or achievements expressed or implied by the statements made. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the Company's ability to raise sufficient funds, the regulatory approval process, results, the Company's patent portfolio, dependence on key personnel and other risks. For further information contact Alexander Hoffman, [email protected], 301-339-0092.

SOURCE Protein Potential, LLC