HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapeutics based on its proprietary
arenavirus platform, today announced updated Phase 1 clinical,
biomarker and translational data on HB-200 as a monotherapy in
heavily pretreated patients with recurrent/metastatic Human
Papillomavirus 16-positive (HPV16+) head and neck cancer. The data
show HB-200 monotherapy induced robust, high-quality and durable
tumor-specific T cell responses, which showed a trend of clinical
benefit measured by a 44 percent disease control rate in a
difficult-to-treat patient population. The data were presented in a
poster presentation (abstract #679) at the 2023 Society for
Immunotherapy of Cancer (SITC) Annual Meeting.
“The data presented at SITC expand the body of
evidence that HB-200 monotherapy has the ability to induce targeted
T cells necessary for tumor control, which can translate into tumor
shrinkage and encouraging clinical activity, especially in a
difficult-to-treat population,” said Joern Aldag, Chief Executive
Officer at HOOKIPA. “As the data have matured, we have consistently
delivered best-in-class T cell activation, and we continue to see
the durability and functionality of tumor-specific T cells induced
by HB-200. We look forward to sharing continued analyses of HB-200
across all arms of our trial in the future.”
HB-200 Phase 1 biomarker
results (NCT04180215)As of March 31,
2023, 93 patients with HPV16+ recurrent/metastatic cancer were
treated in the Phase 1 trial of HB-200. The goal of the trial was
to determine the recommended dose for further evaluation in a Phase
2 study. All patients were heavily pretreated with a median of 3
prior therapies (range 1-11).
Biomarker and translational data resultsHB-200
demonstrated a robust increase in tumor-specific CD8+ T cells in
all evaluable patients with HPV16+ head and neck cancers. These
results are from intracellular staining of blood samples from 35
patients across all four dose levels tested in Phase 1. An analysis
of 29 of these patients—treated at either the recommended phase 2
dose (RP2D) or RP2D-1—showed that T cell increases were rapid and
sustained for at least 8 months, and T cell function improved over
time with repeat dosing. Quantity and quality of T cells are
considered important for tumor infiltration and subsequent tumor
control.
Importantly, paired biopsy data suggest an
association between the induction of robust, high-quality,
tumor-specific T cells after HB-200 treatment and best overall
response. Paired biopsy data from 13 heavily pretreated patients
show that patients who achieved disease control after treatment
with HB-200 monotherapy generally had greater CD8+ T cell
infiltration in tumors and the tumor microenvironment compared to
patients with a best overall response of disease progression.
Additional Phase 1 dataThe poster presentation
also includes updated clinical activity and safety data from the
Phase 1 study. As of the August 7 data cut-off, there were 27
evaluable patients with HPV16+ head and neck cancers who received
HB-200 at the at RP2D or RP2D-1. Among these difficult-to-treat
patients, HB-200 demonstrated a 44 percent disease control rate,
with 1 confirmed partial response and 11 patients with stable
disease. While overall survival is still maturing, median overall
survival is approximately 13 months, with a median follow-up period
of 6.3 months.
Phase 1 data also consistently demonstrate that
HB-200 was generally well tolerated among 93 patients treated
across all dose-level cohorts. Treatment-related adverse events
grade 3 or above were reported in 11.8 percent of patients (n=11),
while those leading to treatment discontinuation were reported in
only 2.2 percent of patients (n=2). This favorable tolerability
profile highlights the potential of HB-200—and arenaviral
immunotherapies in general—to be safely combined with other
immunotherapies.
Data presentation details:
- Title: Characterization of
tumor-specific CD8+ T cell responses in patients with
recurrent/metastatic HPV16-positive head and neck cancer receiving
HB-200 monotherapy as second or later-line treatment in a Phase 1
study
- Presenter: Dr. Winston Wong, Head
and Neck Oncologist at Memorial Sloan Kettering Cancer Center and a
trial investigator
- Abstract: 679
About HB-200HB-200 is HOOKIPA’s
lead oncology candidate engineered with the company’s proprietary
replicating arenaviral vector platform. It comprises two
single-vector compounds with arenaviral backbones based on
lymphocytic choriomeningitis virus and pichinde virus. Both express
the same transgene encoding an E7E6 fusion protein derived from
HPV16. HB-200 is an alternating 2-vector immunotherapy designed to
further focus the immune response against the encoded antigen.
HB-200 in combination with pembrolizumab received Fast Track
Designation from the U.S. Food and Drug Administration for the
treatment of 1st-line recurrent/metastatic HPV16+ head and neck
cancers.
About the HB-200 trial
(NCT04180215)This Phase 1/2 clinical trial is an
open-label trial evaluating HB-200 for the treatment of advanced
HPV16+ cancers. Phase 1 assessed various dose levels, regimen, and
modes of administration in a post-standard of care setting. Based
on safety and tolerability, initial anti-tumor activity and T cell
response data, HB-200 advanced for further development in Phase 2.
The Phase 2 part of the trial is open label with primary endpoints
of efficacy based on objective response and disease control rate as
defined by RECIST 1.1 and iRECIST. The trial is evaluating HB-200
in combination with pembrolizumab in the 1st-line and 2nd-line plus
settings, as well as HB-200 alone in the post-standard of care
setting.
About Human Papillomavirus-driven
CancersHuman Papillomavirus, or HPV, is a common viral
infection estimated to cause about 5 percent of the worldwide
cancer burden. This includes up to 60 percent of head and neck, 89
percent of cervical, 78 percent of vaginal, 88 percent of anal, 67
percent of vulvar and 50 percent of penile cancers.
While there are numerous HPV types associated
with cancer, HPV16 is the most common cause of cancer. Most HPV
infections 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 uptake can potentially lead to cancer since
expression of these proteins leads to alterations in cell cycle
control, which in turn predisposes these cells to become
cancerous.
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
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 public health crises, the impact of
public health crises 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, 2023, which is available on the SEC’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
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channels listed on our investor relations website.
For further information, please contact:
Media |
Investors |
Instinctif Partners |
Michael Kaiser, Investor Relations |
hookipa@instinctif.com |
michael.kaiser@hookipapharma.com |
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+1 (917) 984 7537 |
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