A Vaccine for Lymphatic Filariasis, LFGuard™

PROJECT SUMMARY
Lymphatic filariasis (LF) is a mosquito-transmitted, neglected tropical disease (NTD) affecting over 120 million
people living in 72 countries. Current control strategies for LF infection which rely on annual mass drug
administration (MDA) to the “at-risk” populations has failed to interrupt disease transmission partly due to chronic
reinfection. There is no licensed prophylactic vaccine currently available for the LF, and of those tested over the
last 2 decades have advanced beyond rodent testing. This is partly because of poor protection, but also due to
lack of resources to advance the technology given its truly neglected nature.
We have developed and established the first successful multivalent recombinant fusion protein (Bm-HAXT) for
the prophylaxis of LF called LFGuard™. This vaccine is comprised of a protein antigen, Bm-HAXT, formulated
with the TLR4 agonist GLA-on-Alum. When formulated, our vaccine is highly stable and provides nearly sterile
immunity in rodents (rt95%) and significant protection in non-human primates (70%). To date LFGuard™ has
been extensively tested and confirmed for its prophylactic potential and safety in different animal models such
as mice (n=980), Mongolian gerbils (jirds) (n=220), and rhesus macaques (n=60). In addition to treatment of LF,
LFGuard™ has also shown significant promise in dogs as a vaccine for heartworms.
This SBIR Phase 2 proposal will allow us to move LFGuard™ into pre-clinical development including GMP
manufacture, vialing, and stability and efficacy testing. A clinical study and a supporting toxicology study will be
designed, and stability will be confirmed through both short- and long-term stability programs. Finally, we will
conduct a pre-IND meeting with the FDA prior to execution of the toxicology study. When these studies are
complete, this important antigen will be poised to enter the first human clinical trials for the first ever lymphatic
filariasis vaccine. We propose the following aims for this SBIR Phase 2 grant: (1) Manufacture of BmHAXT under
cGMPs (2) Perform pre-clinical IND-enabling studies.