During 2015, PharmAthene terminated development of SparVax® to focus our resources on development of two next generation Anthrax vaccines. SparVax ® was a liquid Recombinant Protective Antigen (rPA) anthrax vaccine designed to protect against inhalational anthrax, the most lethal form of B. anthracis infection in humans. Vaccination with SparVax ® can generate significant titers of antibodies and up to 100% protection in rabbits and non-human primates that are subsequently exposed to lethal inhalation doses of anthrax spores. SparVax ® human clinical studies involving over 770 individuals showed that it was generally well tolerated and immunogenic. Our next generation Anthrax vaccines use rPA, rPA manufacturing processes and development technologies produced in the SparVax ® program to develop vaccines intended to have significantly improved time to protection, dosing schedules, administration convenience and handling requirements compared to SparVax ®.
On September 9, 2014, PharmAthene signed a contract with NIAID that funds the preclinical development of a next generation lyophilized anthrax vaccine based on the Company’s proprietary technology platform which contributes the rPA bulk drug substance that was used in the liquid SparVax ® formulation. Data generated to date demonstrates that our rPA can be stably formulated in a lyophilized state for room temperature storage. The next phase of the program is a demonstration of the final form of the vaccine in a single unit, dual-chambered syringe designed for simpler storage and ease of use. All of the necessary components of the vaccine will be contained in a single logistics transport and storage will be greatly improved. We expect to commence animal efficacy studies of the lyophilized vaccine in the second quarter of 2016, which if successful, can lead to our filing with the U.S. Food and Drug Administration (FDA) an Investigational New Drug Application (IND) in 2017 and commencement of a subsequent clinical trial.
We intend to seek development partners to fund development and commercialization of our next generation anthrax vaccine.