Altimmune Announces Positive Data From Its Phase 2a Study of NasoVAX Intranasal Influenza Vaccine and Provides an Update on Its Phase 1b Study of HepTcell Targeted Immunotherapy in Chronic Hepatitis B Infection
NasoVAX intranasal influenza vaccine demonstrated strong cellular immune response and 100% seroprotection
HepTcell vaccine was well tolerated but T-cell immunogenicity results were inconclusive
“We strongly believe that NasoVAX could become an important alternative vaccine for the prevention of both seasonal flu epidemics and broader flu pandemics,” said
Enright continued, “As for our HepTcell study, we are disappointed by the inconclusive results, but are continuing to evaluate the data. Subjects will be followed for the full 6 months, as per the study protocol. We are evaluating our next steps and will provide an update as we better understand the results.”
About the Phase 2a NasoVAX Trial
The randomized Phase 2a study compared a monovalent NasoVAX vaccine against an H1 strain of influenza (A/
Data demonstrated 100% seroprotection for the middle and high dose groups of NasoVAX as compared to 95% seroprotection with Fluzone. Mean antibody titers against influenza, as measured by the hemagglutinin inhibition and microneutralization assays increased up to 4.3-fold, indicating that high levels of immunity were induced in this study population, even with prior immunity to the influenza strain (A/
About the Phase 1b HepTcell Trial
The Phase 1b study was a randomized, dose-escalation trial in 60 subjects with chronic HBV infection. Subjects enrolled in the trial were well controlled on currently licensed antiviral therapy and were randomized into one of three groups: high and low dose HepTcell peptides, with and without adjuvant (IC31), adjuvant alone, and placebo. All subjects received 3 injections 4 weeks apart and were followed for 4 weeks after the 3rd injection. Subjects will continue to be followed for 6 months after the 3rd injection, as per the study protocol.
The data showed that, overall, HepTcell was well tolerated. There was one unrelated SAE (infectious colitis). Subjects were monitored carefully for evidence of liver flare, which was not observed in any of the subjects. Additionally, there were no autoimmune events noted. Results showed mild to moderate injection site reactions in < 20% of subjects in every group except the high dose with IC31 (36%). There were no severe injection site reactions.
Previous review of the blinded data by cohort indicated evidence of increased cellular immune responses in cohort 2 compared with cohort 1, both of which included control patients; however, in the unblinded analysis, the treated subjects were not appreciably different than placebo controls.
The company is continuing to evaluate the data and will provide further updates once it has completed its thorough review.
NasoVAX is a novel type of influenza vaccine that uses an adenoviral vector delivery vehicle and intranasal administration to deliver the vaccine to the respiratory tract where influenza infection occurs. Besides its easier intranasal delivery method, NasoVAX has many advantages over current vaccines. First, NasoVAX is a recombinant vaccine that is produced using cell culture, compared to traditional vaccines that use chicken eggs. As described in the
HepTcell is an immunotherapy product candidate directed against multiple hepatitis B virus (HBV) genotypes. HepTcell is a completely synthetic peptide composed of nine Densigen peptides that encode a high density of CD4+ and CD8+ T cell epitopes selected to broaden the HLA class reactivity of the product.
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
William J. Enright
President and CEO
LifeSci Advisors, LLC
Source: Altimmune, Inc.