Elusys Invited to Present LAV-BASTA-48 Anthrax Vaccine at the Annual Defense Threat Reduction Agency (DTRA) Chemical and Biological Science & Technology Annual Conference
Live Attenuated Single-Dose Spore-Based MDR-Anthrax Vaccine elicits protective immunity for postexposure Anthrax prophylaxis
PARSIPPANY, N.J., December 4, 2024 – Elusys Therapeutics has been invited to present on their live attenuated, single-dose anthrax vaccine, LAV-BASTA-48, for protection from inhalational anthrax biothreats. Elusys will present a poster titled “Evaluation of Immunogenicity and Efficacy of a Novel, Live Attenuated Anthrax Spore Vaccine, ‘LAV-BASTA-48’, for Postexposure Prophylaxis (PEP)”, on December 5th, 2024 at the Defense Threat Reduction Agency’s annual Chemical and Biological Science & Technology annual meeting in Ft. Lauderdale. DTRA’s annual scientific conference for CBRN defense is the pre-eminent meeting for Department of Defense-backed medical countermeasures. Elusys’ LAV-BASTA-48 vaccine was funded by the U.S. Department of Defense and is now under development in partnership with the Israel Institute for Biological Research.
“Our LAV-BASTA-48 vaccine has the potential to transform protection of the warfighter from Multi-Drug Resistant Anthrax, using potentially just a single-dose,” stated Jeff Wolf, Elusys CEO. “We are grateful for our partners in Israel and the Department of Defense’s Chemical and Biological Defense Program for their support in this process.”
Based on these compelling data, Elusys and the IIBR seek to examine LAV-BASTA-48 for near-term/post-exposure protection (PEP), perform final IND-enabling efficacy studies, and complete process development and manufacture of GMP drug product for toxicology/Phase 1 evaluations.
About LAV-BASTA-48
LAV-BASTA-48 is a live attenuated anthrax spore vaccine based on disruption of the htrA (High Temperature Requirement A) gene and mutations in the lef and cya genes, encoding for the toxin components lethal factor (LF) and edema factor (EF), in the B. anthracis Sterne veterinary vaccine strain (ΔhtrA;lefMUT;Δcya derivative strain.
This vaccine, which was originally funded by the US Department of Defense (DoD), includes the stepwise addition of several mutations that resulted in a progressive increase in attenuation of the vaccine strain and but did not affect its ability to elicit protective immunity. Immunization of guinea pigs and rabbits with a single or double doses of the BAX vaccine strain induces a robust immune response and provides complete protection against a subsequent respiratory lethal challenge. In rhesus macaques, a single dose of LAV-BASTA-48 protects animals from a lethal challenge with the highly virulent Vollum strain. Acute non-GLP safety measures were reported for treated monkeys revealing no changes in body temperature, weight gain, clinical signs, blood chemistry, or cytology. A mild increase in plasma C-reactive protein (CRP), consistent with a vaccination, was observed. Immunological read-outs included anti-PA, anti-core, and anti-toxin neutralizing antibody (TNA) assays, which correlated with challenge survival and clinical symptoms.
About Elusys Therapeutics, Inc.
Elusys Therapeutics is focused on the development of antibody therapeutics for the treatment of infectious disease. ANTHIM®(obiltoxaximab), the company’s monoclonal antibody (mAb) anthrax antitoxin, received market clearance by the U.S. Food and Drug Administration (FDA) in March 2016. In July 2020, Health Canada approved ANTHIM’s Extraordinary Use New Drug Submission for the treatment of inhalation anthrax. ANTHIM has also received marketing approved in the E.U. and the U.K., under the trade name of Obiltoxaximab SFL. For more information, please visit www.elusys.com.