HOOKIPA Pharma Announces Publication of HB-101 Phase 1 Results in The Journal of Infectious Diseases
April 21 2020 - 7:00AM
HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapeutics targeting infectious diseases and
cancers based on its proprietary arenavirus platform, today
announced the publication in The Journal of Infectious Diseases of
the Phase 1 results of HOOKIPA's VaxWave®-based prophylactic
Cytomegalovirus (CMV) vaccine candidate HB-101, which is currently
in a Phase 2 clinical trial.
The paper concludes that HB-101 was well
tolerated and induced CMV-specific poly-functional CD8 T cell and
neutralizing antibody responses in nearly all subjects. The absence
of vector-neutralizing antibody responses allowed all CMV
antigen-specific immune responses to be increased in a
statistically significant manner upon repeated vaccine
re-administration, which should facilitate additional booster
vaccinations. Hence, HOOKIPA's vaccine candidate holds promise for
prevention of clinically significant CMV infection in transplant
recipients and unborn children.
“The impact of CMV infections, especially in the
field of immunosuppressed patients, like transplant recipients, is
severe and a prophylactic CMV vaccine would be game-changing,”
commented Paul Griffiths, MD DSc FRCPath, Professor of Virology,
Institute of Immunity & Transplantation at University College
London. “The field needs a vaccine that induces both cell-mediated
and humoral immunity. These Phase 1 results from HOOKIPA are very
encouraging, so I look forward to seeing the results from the Phase
2 trial that is underway in transplant patients.”
Cytomegalovirus, or CMV, is a virus that is
commonly transmitted in childhood and early adulthood.
Approximately 60% of the U.S. population has been exposed and is
latently infected. Worldwide data indicate that half the people in
industrialized countries and up to 99% of people in developing
countries, including China and India, have been infected.
Infections typically result in lifelong latent persistence of the
virus with few symptoms, if any. However, in unborn children, when
infected in utero, CMV infection can lead to significant morbidity
and mortality. In addition, in immunosuppressed patients, such as
transplant recipients, primary CMV infection or reactivation of CMV
causes significant morbidity, mortality and graft rejection.
The publication, “A randomized dose-escalating
Phase I trial of a replication-deficient lymphocytic
choriomeningitis virus vector-based vaccine against human
cytomegalovirus,” is available online in The Journal of Infectious
Diseases.
About
HOOKIPAHOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical
stage biopharmaceutical company developing a new class of
immunotherapeutics targeting infectious diseases and cancers based
on its proprietary arenavirus platform that is designed to
reprogram the body’s immune system.
HOOKIPA’s proprietary arenavirus-based
technologies, VaxWave®, a replication-deficient viral vector, and
TheraT®, a replication-attenuated viral vector, are designed to
induce robust antigen specific CD8+ T cells and
pathogen-neutralizing antibodies. Both technologies are designed to
allow for repeat administration to augment and refresh immune
responses. TheraT® has the potential to induce CD8+ T cell response
levels previously not achieved by other immuno-therapy approaches.
HOOKIPA’s “off-the-shelf” viral vectors target dendritic cells in
vivo to activate the immune system.
HOOKIPA’s VaxWave®-based prophylactic
Cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2
clinical trial in CMV-negative patients awaiting kidney
transplantation from living CMV-positive donors as well as
CMV-positive patients awaiting kidney transplantation from
CMV-positive or -negative donors. To expand its infectious disease
portfolio, HOOKIPA has entered into a collaboration and licensing
agreement with Gilead Sciences, Inc. to jointly research and
develop functional cures for HIV and chronic Hepatitis B
infections.
In addition, HOOKIPA is building a proprietary
immuno-oncology pipeline by targeting virally mediated cancer
antigens, self-antigens and next-generation antigens. The TheraT®
based lead oncology product candidates, HB-201 and HB-202, are in
development for the treatment of Human Papilloma Virus16-positive
cancers. The Phase 1/2 clinical trial for HB-201 was initiated in
December 2019. The HB-202 IND submission is intended for the first
half of 2020.
Find out more about HOOKIPA online at
www.hookipapharma.com.
HOOKIPA 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 and other matters that could affect the sufficiency
of existing cash to fund operations and HOOKIPA’s ability to
achieve the milestones under the agreement with Gilead. 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 full year ended December 31,
2019 which is 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
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
Nina Waibel
Senior Director - Communications
nina.waibel@hookipapharma.com |
InvestorsMatt Beck Executive
Director - Investor Relationsmatthew.beck@hookipapharma.com |
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Media enquiriesAshley TappInstinctif
Partnershookipa@instinctif.com+44 (0)20 7457 2020 |
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