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GAITHERSBURG, Md., Jan. 29, 2019 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, today announced results of its recently completed HepTcell Phase 1 clinical trial will be presented on April 12, 2019 at The International Liver Congress sponsored by The European Association for the Study of the Liver (EASL) being held in Vienna, Austria April 10-14, 2019.
As previously announced, this study met its primary endpoint of safety and showed that HepTcell treatment was associated with increased HBV-specific cellular immune responses. These results will be presented by Mark Thursz, MB BS, MD, FRCP, Professor of Hepatology at Imperial College, London as an oral presentation in the session entitled, Hepatitis B – Drug Development.
“I am very pleased to present these exciting HepTcell data at EASL’s Liver Congress,” said Professor Thursz, Chief Investigator for the HepTcell Phase 1 study. “HepTcell’s impact on HBV specific cellular immune responses is very encouraging and the safety profile is excellent.”
Hepatitis B virus (HBV) has infected more than 2 billion people worldwide. The majority of adults infected with HBV achieve spontaneous clearance via HBV-specific CD4+ and CD8+ T cells; however, more than 257 million people worldwide, of which 2 million patients are in the United States, remain chronically infected. HBV remains a leading cause of death globally due to complications such as cirrhosis, liver failure and hepatocellular carcinoma. Patients with chronic infection have profound defects in magnitude and quality of anti-HBV T-cell responses and breaking this immune tolerance is a key goal for all novel HBV treatment strategies.
Altimmune’s HepTcell is a specific HBV immunotherapeutic designed to drive CD4+ and CD8+ T-cell responses against all HBV genotypes in patients of all ethnic backgrounds. HepTcell focuses the immune system on discrete highly conserved regions of the HBV proteome. We believe our approach allows HepTcell to activate less tolerized T cells resulting in greater activity and decreased probability of immune escape due to viral mutation. HepTcell, a fully synthetic peptide product, is reconstituted with Valneva’s depot-forming IC31™ TLR9 adjuvant and given by intramuscular injection.
The HepTcell Phase 1 study was a double-blinded, placebo-controlled, randomized, dose-escalation trial that enrolled 60 subjects with chronic hepatitis B who were HBeAg negative and well-controlled on licensed antivirals. Forty patients received one of two dose levels of HepTcell, with and without Valneva’s IC31 adjuvant, while twenty control patients received either placebo or IC31 alone. All patients received 3 injections 28 days apart, and were followed for 6 months after the final dose.
All dose combinations showed excellent tolerability and met the primary endpoint of safety. In the two adjuvanted HepTcell arms, T cell responses against HBV markedly increased over baseline compared to placebo. Altimmune plans to advance the program into Phase 2 development.
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. NasoVAX, our influenza vaccine candidate, has unique characteristics that stimulate multiple arms of the immune system and offers the potential to stop infection and the spread of flu, while being easier to administer through an intranasal spray. NasoShield is a next-generation intranasal anthrax vaccine candidate that is intended to improve protection and safety while having favorable dosage and storage properties compared to other anthrax vaccines. HepTcell is a synthetic peptide immunotherapeutic candidate designed to break immune tolerance in chronic Hepatitis B infection. By leveraging the complementary attributes of our proprietary technology platforms, Altimmune is able to design and develop immunotherapeutic products tailored to address a wide range of disease indications including both acute and chronic infections and cancer. Additional information about Altimmune is available at www.altimmune.com.
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, 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: the terms of the Company’s Series B preferred stock offering and related warrants; our lack of financial resources and access to capital; 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. 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 Company’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, which are available at www.sec.gov.
Vipin K. Garg, Ph.D.
President and CEO
Ashley R. Robinson
Managing Director, LifeSci Advisors