HOOKIPA Announces First Person Dosed in Phase 1a/b Clinical Trial of HB-400, in Collaboration with Gilead, for Treatment of Hepatitis B
09 5월 2023 - 8:01PM
HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapeutics based on its proprietary
arenavirus platform, today announced that the first person has been
dosed in a Gilead-led Phase 1 clinical trial of HB-400, an
investigational therapeutic vaccine for chronic hepatitis B. HB-400
is one of two novel compounds being developed in collaboration with
Gilead.
“Dosing of the first person in the Phase 1
clinical trial of HB-400 is an important milestone for HOOKIPA, as
another program with our novel arenaviral technology progresses to
the clinic,“ said Joern Aldag, Chief Executive Officer at HOOKIPA.
”More importantly, the start of the HB-400 trial is an important
milestone for the hepatitis B community as hepatitis B remains an
area of critical unmet need. We look forward to working with Gilead
to assess the potential impact of our novel arenaviral technology
as part of a combination regimen for people living with the
disease.”
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.
The Phase 1 clinical trial (NCT05770895) aims to
evaluate the safety and tolerability of repeated doses of HB-400 in
healthy participants and participants with chronic hepatitis B.
Gilead is solely responsible for further development and
commercialization of HB-400, referenced as GS-2829 and GS-6779.
HOOKIPA earned a $5 million non-dilutive
payment under its collaboration agreement in January 2023,
following the submission of the clinical trial application (IND
equivalent) and the completion of the regulatory support package
for the Phase 1 clinical trial.
The hepatitis B program is one of two
independent development programs in HOOKIPA’s collaboration
and license agreement with Gilead. The other program aims to
develop a novel arenaviral vaccine as a component of a potential
functional curative regimen for human immunodeficiency virus (HIV).
HOOKIPA is responsible for advancing the investigational HIV
therapeutic vaccine through completion of a Phase 1b clinical
trial.
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.
For further
information, please contact: |
MediaInstinctif Partnershookipa@instinctif.com+44
(0)20 7457 2020 |
InvestorsReinhard Kundera, Chief Financial
OfficerIR@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 the coronavirus (COVID-19) disease
outbreak or similar public health crises, the impact of COVID-19 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 annual report on Form 10-K for the year ended
December 31, 2022, which is available on the Security and
Exchange Commission’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
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