On March 12, 2018 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported data from a pre-clinical study comparing SparVax-L and BioThrax against anthrax infection (Press release, Altimmune, MAR 12, 2018, View Source [SID1234524667]). Data from the study showed a 67% survival rate in animals challenged with a lethal dose of anthrax after a single dose of SparVax-L, an anthrax vaccine currently being developed through funding from the National Institute of Allergy and Infectious Diseases (NIAID) and previously through funding from the Biomedical Advanced Research and Development Authority (BARDA).
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"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."
The study compared SparVax-L to BioThrax, the currently approved vaccine against anthrax infection. SparVax-L uses a well-accepted adjuvant formulation with a clear regulatory pathway for safety and efficacy. The results of this study showed a 67% survival rate after a single dose of SparVax-L, and 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. Additionally, SparVax-L showed significantly more toxin neutralizing antibodies (TNA) after the two doses when compared to BioThrax. TNA is the key surrogate for protection in clinical studies of anthrax vaccines.
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.
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. The Company is seeking additional government funding to further advance the stable lyophilized formulation in human clinical studies.