HOOKIPA Pharma announces publication of preclinical data of hepatitis B virus (HBV) therapeutic vaccine developed in collaboration with Gilead Sciences
October 18 2023 - 7:01AM
HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapeutics based on its proprietary
arenavirus platform, today announced that The Journal of Infectious
Diseases has published preclinical data on HB-400, an
investigational therapeutic vaccine for chronic hepatitis B
developed in collaboration with Gilead Sciences, Inc. (HB-400 is
also referenced as GS-2829 and GS-6779.) The published data
highlight HB-400 as a potential component in achieving a functional
cure for chronic hepatitis B.
HB-400 is an alternating, 2-vector
non-replicating arenaviral therapeutic vaccine for the treatment of
chronic hepatitis B. It uses the Lymphocytic Choriomeningitis Virus
and Pichinde Virus as arenaviral backbones, with each expressing
three highly conserved hepatitis B virus antigens. HOOKIPA’s
alternating 2-vector approach is designed to optimize and focus the
immune response against the target antigens. HB-400 is one of two
independent development programs in HOOKIPA’s collaboration and
license agreement with Gilead Sciences, Inc.
The preclinical data published in The Journal of
Infectious Diseases show that:
- Immunization with HB-400 induced
robust, hepatitis B-specific T cell and antibody responses in
non-human primates; and
- HB-400 vaccination cleared
detectable serum hepatitis B antigens in a mouse model for chronic
HBV infection, with near elimination of detectable hepatitis B
antigen positive hepatocytes in the liver.
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 participants
and individuals with chronic hepatitis B. Gilead is solely
responsible for further development and commercialization of
HB-400.
“The lack of curative therapies for chronic
hepatitis B infection is a significant barrier to addressing the
global burden of disease,” said Joern Aldag, Chief Executive
Officer at HOOKIPA. “We’re pleased to see our novel arenaviral
platform technology featured in this reputable journal, and we look
forward to seeing how clinical results of Gilead’s ongoing Phase 1
trial of HB-400 may further support its potential as a component of
a functional cure regimen for hepatitis B.”
About Hepatitis BHepatitis B
virus is the leading cause of liver cancer, as well as a major
cause of cirrhosis, liver failure and death globally. It is
estimated that nearly 300 million people live with chronic
hepatitis B infection, and there are 1.5 million new infections
annually.
About HOOKIPAHOOKIPA Pharma
Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company
focused on developing novel immunotherapies, based on its
proprietary arenavirus platform, which are designed to mobilize and
amplify targeted T cells and thereby fight or prevent serious
disease. HOOKIPA’s replicating and non-replicating technologies are
engineered to induce robust and durable antigen-specific CD8+ T
cell responses and pathogen-neutralizing antibodies. HOOKIPA’s
pipeline includes its wholly owned investigational arenaviral
immunotherapies targeting Human Papillomavirus 16-positive cancers,
prostate cancers, and other undisclosed programs. HOOKIPA is
collaborating with Roche on an arenaviral immunotherapeutic for
KRAS-mutated cancers. In addition, HOOKIPA aims to develop
functional cures of HBV and HIV in collaboration with Gilead.
Find out more about HOOKIPA online
at www.hookipapharma.com.
Forward Looking
StatementsCertain statements set forth 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 terms such
as “believes,” “expects,” “plans,” “potential,” “would” or similar
expressions and the negative of those terms. Such forward-looking
statements involve substantial risks and uncertainties that could
cause HOOKIPA’s research and clinical development programs, future
results, performance or achievements to differ significantly from
those expressed or implied by the forward-looking statements. Such
risks and uncertainties include, among others, the uncertainties
inherent in the drug development process, including HOOKIPA’s
programs’ early stage of development, the process of designing and
conducting preclinical and clinical trials, the regulatory approval
processes, the timing of regulatory filings, the challenges
associated with manufacturing drug products, HOOKIPA’s ability to
successfully establish, protect and defend its intellectual
property, risks relating to business
interruptions resulting from public health crises, the impact of
public health crises on the enrollment of patients and timing of
clinical results, and other matters that could affect the
sufficiency of existing cash to fund operations. HOOKIPA
undertakes no obligation to update or revise 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, as well as risks
relating to the business of the company in general, see HOOKIPA’s
quarterly report on Form 10-Q for the quarter ended
June 30, 2023, which is available on the SEC’s website
at www.sec.gov and HOOKIPA’s website
at www.hookipapharma.com.
Investors and others should note that we
announce material financial information to our investors using our
investor relations website (https://ir.hookipapharma.com/), SEC
filings, press releases, public conference calls and webcasts. We
use these channels, as well as social media, to communicate with
our members and the public about our company, our services and
other issues. It is possible that the information we post on social
media could be deemed to be material information. Therefore, we
encourage investors, the media, and others interested in our
company to review the information we post on the U.S. social media
channels listed on our investor relations website.
For further information, please contact:
Media |
Investors |
Instinctif Partners |
Michael Kaiser, Investor Relations |
hookipa@instinctif.com |
michael.kaiser@hookipapharma.com |
+44 (0) 7457 2020 |
+1 (917) 984-7537 |
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