Anthrax Vaccine Program Advances

A clinical-stage immunotherapeutics company announced data from a pre-clinical study comparing SparVax-L and BioThrax® against anthrax infection.

This limited study showed a 67 percent survival rate in animals challenged with a lethal dose of anthrax, after a single dose of SparVax-L.

Additionally, SparVax-L reported a 100% survival rate after two doses at day 0 and day 14 when challenged at Day 28, which was comparable to BioThrax’s 96% survival rate after two doses.

The dose of SparVax-L used in this study was low compared to what is supported by existing safety and toxicology studies which indicates that better single-dose protection may be achieved with a higher dose, says Altimmune, Inc. a clinical-stage immunotherapeutics company.

Additionally, SparVax-L showed significantly more toxin neutralizing antibodies (TNA) after the two doses when compared to BioThrax.

SparVax-L is being developed as a second generation, highly purified recombinant anthrax vaccine requiring only two vaccinations for protection.

SparVax-L is further differentiated by its ability to be stored at room temperature, making it well-suited for stockpiling in the Strategic National Stockpile.

“We are very encouraged by these data and look forward to continuing to develop this important vaccine,” said William J. Enright, president and chief executive officer of Altimmune.

“Nearly 700 volunteers have been dosed with a liquid formulation of this vaccine in previous Phase 1 and Phase 2 human studies. These data using a new, highly stable, lyophilized (freeze-dried) formulation, continue to validate this approach and strongly support further development of SparVax-L.”

SparVax-L uses a well-accepted adjuvant formulation with a clear regulatory pathway for safety and efficacy.

Anthrax is a serious infectious disease caused by gram-positive, rod-shaped bacteria known as Bacillus anthracis. Although it is rare, people can get sick with anthrax if they come in contact with infected animals or contaminated animal products, says the CDC.

During March 2017, Emergent BioSolutions Inc. announced that it has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), for the delivery of BioThrax to the Strategic National Stockpile.

Additionally, Emergent BioSolutions signed a modification to its 2016 contract with BARDA for the development over a 5-year base period of NuThrax for post-exposure prophylaxis of anthrax.

Expectations are that the FDA could authorize the vaccine for emergency use in 2018, with stockpile shipments to beginning in 2019.

This project has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201400040C and the Biomedical Advanced Research and Development Authority (BARDA) under contract No. HSS01002009000103C.