HOOKIPA Announces FDA Clearance of its IND Application for HB-202/201 Clinical Trial to Treat HPV-Positive Cancers
June 17 2020 - 7:00AM
HOOKIPA Pharma Inc. (NASDAQ: HOOK), a company developing a new
class of immunotherapeutics targeting infectious diseases and
cancers based on its proprietary arenavirus platform, today
announced that the U.S. Food and Drug Administration (FDA) has
cleared its Investigational New Drug (IND) Application for HB-202.
This IND allows HOOKIPA to initiate an additional arm in its Phase
1/2 clinical trial for HB-201 (NCT04180215) for the treatment of
Human Papillomavirus 16-positive (HPV 16+) cancers. With the
IND clearance of HB-202, HOOKIPA will be able to examine not only
the safety and efficacy of HB-201 alone but also HB-201 in
combination with HB-202 as an alternating two-vector therapy.
In preclinical studies, HOOKIPA has observed
that the sequential administration of HB‑202 and HB‑201 induced
tumor specific CD8 T cell levels that were greater than levels
achieved after the repeat administration of either agent alone. The
presence of tumor specific CD8 T cells are believed to be an
indicator of anti-tumor activity.
HB-202 and HB-201 have been engineered from
different viruses of the arenavirus family. Both constructs express
the same non-oncogenic but highly antigenic, E7/E6 fusion protein
derived from HPV16. In a mouse model of HPV16+ tumors, single doses
of HB‑202 were shown to be similarly effective as single doses of
HB‑201. The combination of HB-202 and HB-201 in the same model has
been shown to eliminate the tumor and prevent recurrence in a
certain number of mice. In 2021, HOOKIPA expects to also combine
HB-202/201 with an approved checkpoint inhibitor.
Joern Aldag, HOOKIPA’s Chief Executive Officer,
said: “This is a tremendous achievement for HOOKIPA’s oncology
platform and new applications of our arenavirus technologies. I
commend the HOOKIPA team for its steadfast focus on the execution
of this project under difficult, COVID-19 pandemic
circumstances. We are eager to continue screening and
treating patients at our HB-201 clinical sites as they are coming
back online, and look forward to treating the first HB-202/201
patient later this year.”
About Human
Papillomavirus (HPV) - associated head and neck cancersHPV
is estimated to cause about 5% of the worldwide burden of cancers,
including approximately 99% of cervical cancers, 25% to 60% of head
and neck cancers, 70% of vaginal cancers, and 88% of anal cancers.
The majority of these cancers are caused by the HPV serotype 16.
Most infections with HPV are cleared from the body with no lasting
consequences. However, in some cases, HPV DNA becomes integrated
into chromosomal DNA. When host cells take up this DNA, they
express the HPV E6 and E7 proteins. This can potentially lead to
cancer, since expression of these proteins leads to alterations in
cell cycle control, which in turn predisposes these cells to
becoming cancerous.
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 Virus 16-positive
cancers. The Phase 1/2 clinical trial for HB-201 was initiated in
December 2019. The HB-202 IND application was cleared by the FDA in
June 2020.
Find out more about HOOKIPA online at
www.hookipapharma.com.
HOOKIPA Forward Looking
Statements
Certain 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 for HB-101 and other programs, 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 quarterly report on Form 10-Q for
the quarter ended March 31, 2020 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
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:
MediaNina Waibel Senior Director -
Communications nina.waibel@hookipapharma.com
InvestorsMatt BeckExecutive Director - Investor
Relationsmatthew.beck@hookipapharma.com
Media enquiries Instinctif Partners
hookipa@instinctif.com +44 (0)20 7457 2020
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