Y. Xu, B. Brooks, Z. Zhou, C. Tison
Luna Innovations Inc,
Keywords: antivenom, nanoparticle
Summary:Abstract: Venomous bites could negatively impact the health and effectiveness of warfighters. In particular, Special Operations Forces that typically deploy in austere areas in the AFRICOM and PACOM regions are associated with an increased risk of envenomation. Current treatment uses species-specific or polyvalent antivenins that are generated from the sera of animals immunized with whole venom, necessitating the correct identification of the venomous species and continuous injection of large volume of antibodies at an ICU-capable medical facility with increased risk of life-threatening complications. There is a clear capability gap to protect deployed soldiers against venom exposure. Luna has developed a new class of affinity polymeric nanoparticles that can capture and neutralize a broad range of medically important venom toxins as universal antivenom. This product is ambient-temperature stable as a safer alternative to their biological counterparts. Size and surface charge have been characterized over extended storage, with no changes as determined by SEM/TEM and Dynamic Light Scattering measurements. A single antivenom NP formulation neutralized multiple sub-classes of venom toxins from different snakes. At all doses tested (0-180 mg/kg), significantly and dose-dependently enhanced survival of animals administered with Puff Adder venom, Gaboon Viper venom, Jameson’s Mamba venom, and Black Mamba venom in premixing or post- injection NP tests. 10-gram level of NP synthesis scale has been developed at Luna. A UV method for determining NP concentration in PBS buffer was validated by CRL in order to measure the stability of NP solution. Acute toxicity for rats was not seen at doses up to and including 300 mg/kg at the 4 days study. In dog tolerant toxicity studies, the maximum dose for administration should not exceed 200 mg/kg/day. Currently, Luna is working on characterizing pharmacokinetics, and biodistribution in compliance with GLP standards.