Single dose of vaccine showed 67% survival rate and 100% survival rate after two doses
GAITHERSBURG, Md., March 12, 2018 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, today announced data from a pre-clinical study comparing SparVax-L and BioThrax® against anthrax infection. 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).
“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.
Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease including NasoVAX, a Phase 2 seasonal influenza vaccine candidate, and HepTcell, a Phase 1 immunotherapeutic candidate for the potential cure of chronic hepatitis B. The company also has two United States government funded, next-generation anthrax vaccine candidates that are intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines.
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any product or drug candidates, and the Company’s leadership are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: realizing the benefits of the merger between Altimmune, Inc. and PharmAthene, Inc.; clinical trials and the commercialization of proposed product candidates (such as marketing, regulatory, product liability, supply, competition, dependence on third parties and other risks); the regulatory approval process; dependence on intellectual property; the Company’s BARDA contract and other government programs, reimbursement and regulation; and the lack of financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Form 10-K filed March 14, 2017, Forms 10-Q filed August 14, 2017 and November 9, 2017, and in a Form 8-K filed August 17, 2017, which are available at www.sec.gov.
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