HOOKIPA Pharma Announces Preclinical Data for Hepatitis B Virus (HBV) Therapeutic Vaccine Developed in Collaboration with Gilead Sciences

  • HB-400 is a novel arenavirus therapeutic vaccine that generates robust T cell responses against hepatitis B virus with high antibody levels in a preclinical setting
  • A phase 1 clinical trial led by Gilead is underway to evaluate the safety and tolerability of HB-400 in humans
  • Peer-reviewed data published in thisJournal of Infectious Diseases

NEW YORK and VIENNA, Austria, Oct. 18, 2023 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. (Nasdaq: HOOK, “HOOKIPA”) is a company developing novel immunotherapeutics based on its proprietary arenavirus platform company, announced today thisJournal of Infectious Diseases Preclinical data have been released for HB-400, an investigational therapeutic vaccine for chronic hepatitis B developed in partnership with Gilead Sciences. (HB-400 is also known as GS-2829 and GS-6779.) Published The data highlight HB-400 as a potential component to achieve a functional cure for chronic hepatitis B.

HB-400 is an alternating, 2-vector non-replicating arenavirus therapeutic vaccine for the treatment of chronic hepatitis B. It uses lymphocytic choriomeningitis virus and Pichand virus as arenavirus backbones, each expressing three highly conserved hepatitis B virus antigens. HOOKIPA’s alternating 2-carrier approach is designed to optimize and focus the immune response against the target antigen. HB-400 is one of two independently developed programs under HOOKIPA’s collaboration and licensing agreement with Gilead Sciences, Inc.

Preclinical data published in thisJournal of Infectious Diseases show:

  • HB-400 immunization induced strong hepatitis B-specific T cell and antibody responses in non-human primates; and
  • HB-400 vaccination eliminated detectable serum hepatitis B antigen and nearly eliminated detectable hepatitis B antigen-positive hepatocytes in the liver in a mouse model of chronic HBV infection.

A Gilead-led Phase 1 clinical trial (NCT05770895) is currently underway to evaluate the safety and tolerability of repeated doses of HB-400 in healthy subjects and patients with chronic hepatitis B. Gilead has full responsibility for the further development and commercialization of HB-400.

“The lack of treatments for chronic hepatitis B infection is a significant obstacle to addressing the global disease burden,” said Joern Aldag, CEO of HOOKIPA. “We are pleased to see our novel arenavirus platform technology appear in this prestigious journal, and we Look forward to seeing how clinical results from Gilead’s ongoing Phase 1 trial of HB-400 further support its potential as part of a functional cure regimen for hepatitis B.”

About hepatitis B
Hepatitis B virus is the leading cause of liver cancer and the leading cause of cirrhosis, liver failure and death worldwide. It is estimated that nearly 300 million people suffer from chronic hepatitis B infection, with 1.5 million new infections every year.

About Hokipa
HOOKIPA Pharma Inc. (Nasdaq: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies based on its proprietary arenavirus platform designed to mobilize and amplify targeted T cells to fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and long-lasting antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly-owned investigational arenavirus immunotherapies for human papillomavirus 16-positive cancers, prostate cancer and other undisclosed programs. HOOKIPA is collaborating with Roche to develop an arenavirus immunotherapy for KRAS-mutant cancers. In addition, HOOKIPA also plans to cooperate with Gilead to develop functional treatments for HBV and HIV.

Learn more about HOOKIPA online at www.hookipapharma.com.

forward-looking statements
Certain statements in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terminology such as “believes,” “anticipates,” “plans,” “potential,” “will” or similar expressions, as well as the negative of these terms. Such forward-looking statements involve significant risks and uncertainties that could cause HOOKIPA’s research and clinical development plans, future results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the uncertainties inherent in the drug development process, including the early development stages of the HOOKIPA program, the process of designing and conducting preclinical and clinical trials, the regulatory approval process, the timing of regulatory filings, and the relationship with the drug product. manufacturing-related challenges, HOOKIPA’s ability to successfully establish, protect and defend its intellectual property rights, Risks related to business disruption resulting from the public health crisis, the impact of the public health crisis on patient enrollment and the timing of clinical results, and other matters that may affect the adequacy of existing cash operating funds. HOOKIPA undertakes no obligation to update or review any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements and for a further description of the risks associated with the Company’s overall business, please see HOOKIPA’s Quarterly Report on Form 10-Q for the Year Ended June 30, 2023 Daily quarterly data are available on the SEC’s website at www.sec.gov and HOOKIPA’s website at www.hookipapharma.com.

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HOOKIPA Pharma Announces Preclinical Data for Hepatitis B Virus (HBV) Therapeutic Vaccine Developed in Collaboration with Gilead Sciences

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