HOOKIPA announces strategic collaboration and license agreement with Roche to develop novel arenaviral immunotherapy for KRAS-mutated cancers
October 20 2022 - 07:00AM
GlobeNewswire Inc.
HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapies based on its proprietary arenavirus
platform, announced today a strategic collaboration and license
agreement with Roche to develop HB-700 for KRAS-mutated cancers and
a second undisclosed novel arenaviral immunotherapy. This
represents HOOKIPA’s first oncology licensing collaboration.
Through the collaboration, HOOKIPA will conduct
research and early clinical development through Phase 1b for
HB-700, a novel investigational arenaviral immunotherapy for the
treatment of KRAS-mutated cancers. Upon the completion of the Phase
1b trial, Roche has the right to assume development responsibility
and to commercialize licensed products across multiple indications
upon approval. The agreement also includes an option for Roche to
license a second arenaviral cancer immunotherapy.
“Roche is an ideal partner, both in terms of
development and reaching patients with novel cancer therapeutics.
We look forward to working with them to benefit people with
KRAS-mutated cancers,” said Joern Aldag, Chief Executive Officer at
HOOKIPA. “This collaboration validates the potential of our
arenavirus platform and accelerates the development pathway to
bring new treatments to people with cancer.”
“We are excited to collaborate with HOOKIPA in
leveraging their arenaviral technology, which has clinically
demonstrated the ability to induce potent antigen specific CD8+ T
cell responses and represents a promising approach for new cancer
immunotherapies,” said James Sabry, Global Head of Pharma
Partnering at Roche. “This collaboration further strengthens our
leadership in oncology, and we are optimistic about advancing this
innovative platform to potentially provide more options for people
with KRAS-mutated cancers, as well as other potential cancer
types.”
Under the terms of the agreement, HOOKIPA will
receive an upfront payment of $25 million. Roche will have the
option to expand the initial collaboration by adding an additional
product candidate, whereafter HOOKIPA will receive an additional
$15 million payment at option exercise. Including this option
payment, HOOKIPA is eligible for research, development and
commercialization milestone-based payments for HB-700 and the
additional product candidate totaling up to approximately $930
million. Upon commercialization, HOOKIPA is eligible to receive
tiered royalties of a high single-digit to mid-teens percentage on
the worldwide net sales of HB-700 and the additional product
candidate.
About KRAS-mutated cancersKRAS
is a gene that acts as an on/off switch for cell growth. When there
is a mutation, or error, in the gene, cells can grow out of
control. KRAS mutations are among the most common mutations that
cause cancer. While KRAS-mutated, tumor-specific treatments exist,
there remains an opportunity to target a broader range of
KRAS-mutations simultaneously to potentially help more people
impacted by these cancers.
About HOOKIPA’s Arenaviral
TechnologyHOOKIPA’s novel, replicating arenaviral
technology has demonstrated the ability to induce potent
antigen-specific T cell responses and promising anti-tumor activity
in a Phase 1 clinical trial which treated patients with advanced
Human Papillomavirus 16-positive head and neck cancers. Preclinical
studies have also demonstrated the ability of arenaviral
immunotherapies to break self-tolerance and induce potent T cell
responses to tumor self-antigens and mutated epitopes, or target
parts of a mutated, cancer-causing gene. These findings provide
scientific rationale for the HB-700 program.
About HB-700HB-700 is an
investigational arenaviral immunotherapy designed to treat
KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700
is a replicating 2-vector therapy that targets the most common KRAS
mutations: (G12D, G12V, G12R, G12C and G13D) and thereby benefits
more patients than single mutation inhibitors.
About HOOKIPA
HOOKIPA 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:
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Investors |
Instinctif
Partners
hookipa@instinctif.com+44 (0)20 7457 2020 |
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Matt
Beck
Executive Director - Investor
Relationsmatthew.beck@hookipapharma.com+1 917 209 6886 |
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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, 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, 2022, which is available on the Security and Exchange
Commission’s website at www.sec.gov and HOOKIPA’s website
at www.hookipapharma.com.
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