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 that the first patient has been dosed in a Phase 1/2
clinical trial (NCT04180215) of HB-201, an immunotherapy for the
treatment of Human Papillomavirus 16-positive (HPV16+) cancers.
This trial is HOOKIPA’s first clinical trial in immuno-oncology.
HB-201 is a TheraT® platform-based vector
(replication attenuated) from the arenavirus family expressing a
non-oncogenic but highly antigenic E6/E7 fusion protein from HPV16.
In preclinical studies, HB-201 was observed to be highly
immunogenic, resulting in a robust CD8+ T cell response as compared
to the levels induced by other approaches including adoptive cell
therapies. In addition to strong immunogenicity, HOOKIPA observed
robust anti-tumor activity in mouse models. HOOKIPA believes that
HB-201 has the potential to provide therapeutic benefit to patients
across the HPV16+ cancer setting.
Joern Aldag, Chief Executive Officer at HOOKIPA,
commented: “We are excited to begin first-in-human testing with
HB-201, our first clinical trial in immuno-oncology. Translating
our promising preclinical data to cancer patients is an important
milestone. We believe HOOKIPA’s approach can supercharge the
natural defence mechanisms by inducing strong T cell responses to
the benefit of patients affected by cancer and infectious
diseases.”
About the HB-201 Clinical
Trial
The HB-201 Phase 1/2 trial is an open-label
dose-escalation and dose-expansion trial in 100 patients with
treatment-refractory HPV16+ cancers. It is designed to evaluate the
safety and tolerability and preliminary efficacy of HB-201 as
monotherapy and in combination with an immune checkpoint
inhibitor.
For Phase 1 dose escalation, the patient
population will be divided into two groups of 20 patients, each:
the first group will include patients with progressing HPV16+
tumors who will receive monthly intravenous (IV) administration of
HB-201; the second group will include patients with progressing
HPV16+ tumors and an accessible tumor site who will receive one
intratumoral (IT) administration of HB-201 followed by monthly IV
administration of HB-201.
The primary endpoint of the Phase 1 portion of
this trial will be to evaluate safety and tolerability to determine
the recommended dose for the Phase 2 portion. Secondary endpoints
will evaluate anti-tumor activity, as defined by RECIST (Response
Evaluation Criteria In Solid Tumors) 1.1, and immunogenicity. The
Phase 2 portion of the trial will also investigate the efficacy of
HB-201 alone and in combination with a PD-1 inhibitor. HOOKIPA
expects to provide interim safety, dose escalation, and efficacy
data from HB-201 in late 2020 or early 2021. These data will be
supplemented by a series of translational data sets designed to
demonstrate the mechanism of action.
About Human Papillomavirus
Human Papillomavirus (HPV) is estimated to cause
about 5% of the worldwide burden of cancer including approximately
99% of cervical cancers, 25% to 60% of head and neck cancers, 70%
of vaginal cancers and 88% of anal cancers1. 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.
1
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5520228/
About
HOOKIPA
HOOKIPA 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 vaccine candidate is currently in a Phase 2
clinical trial in patients awaiting kidney transplantation from
living Cytomegalovirus-positive 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 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 filing is intended for the first half
of 2020.
Find out more about HOOKIPA online at
www.hookipapharma.com.
*Registered in Europe; Pending in the US.
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 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 September 30, 2019 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 |
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Media enquiries Ashley Tapp Instinctif
Partners Hookipa@Instinctif.com +44 (0)20 7457 2020 |
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