HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company
developing a new class of immunotherapeutics based on its
proprietary arenavirus platform, today announced positive
preliminary data from its ongoing Phase 2 study of HB-200 in
combination with pembrolizumab in patients with
recurrent/metastatic Human Papillomavirus 16-positive (HPV16+) head
and neck cancer. New data show a 43 percent objective response rate
(ORR) with HB-200 in combination with pembrolizumab in checkpoint
inhibitor (CPI)-naïve patients, doubling the 19 percent response
rate for pembrolizumab alone. HOOKIPA plans to share the full data
at a medical conference later this year and is preparing to start a
pivotal trial of HB-200 in combination with pembrolizumab in the
1st-line setting in 2024. The company will host a webcast call June
1st at 8:00 a.m. EDT.
“Given the unmet medical need for patients with
recurrent/metastatic HPV16+ head and neck cancers, we are thrilled
to share the preliminary data on HB-200 in combination with
pembrolizumab as they show a robust improvement in objective
response rate and prolonged tumor control compared to pembrolizumab
alone,” said Joern Aldag, Chief Executive Officer at HOOKIPA.
“Efficacy, immunogenicity and safety data observed in our HB-200
program to-date support our decision to progress to a pivotal trial
of HB-200 in combination with pembrolizumab as 1st-line treatment
for these patients. The data also underscore the scalability of our
arenaviral platform across a range of cancers.”
HB-200 results
(NCT04180215)As of March 31, 2023, 35 patients
with HPV16+ recurrent/metastatic head and neck cancers received
HB-200 in combination with pembrolizumab as part of the Phase 2
study: 20 patients were treated with HB-200 and pembrolizumab in
the 1st-line setting and 15 in the 2nd-line setting. All received
HB-200 intravenously every three weeks for the first five doses and
every six weeks thereafter. HB-200 means 2-vector therapy with
alternating application of HB-201 (LCMV), HB-202 (PICV) vectors,
encoding HPV16 E6/E7 antigens.
1st-line combination dataHB-200 in combination
with pembrolizumab demonstrated promising anti-tumor activity with
a 43 percent objective response rate (6 of 14 patients with
confirmed responses by investigator assessment under RECIST 1.1)
among CPI-naïve patients with recurrent/metastatic HPV16+ PD-L1+
head and neck cancer. These data represent a doubling of the 19
percent objective response rate reported with pembrolizumab alone.1
As of March 31, 2023, 14 patients with at least two imaging
assessments were included in the interim efficacy analysis. Six
patients responded (one with confirmed complete response and five
with confirmed partial responses), with a 71 percent disease
control rate (10 of 14 patients), meaning stable disease or a
complete or partial response. While recruitment is ongoing, based
on these data, HOOKIPA is preparing to start a pivotal trial of
HB-200 in combination with pembrolizumab as 1st-line treatment of
recurrent/metastatic HPV16+ PD-L1+ head and neck cancers in
2024.
2nd-line plus combination dataData on HB-200 in
combination with pembrolizumab in the 2nd-line plus setting are
trending positively in this small initial cohort, but they are
preliminary and need further maturation. As of March 31, 2023, five
patients with at least two imaging assessments were included in the
interim efficacy analysis based on RECIST 1.1. Preliminary results
show one confirmed partial response and three patients with stable
disease. Preliminary median progression-free survival in this small
cohort was 5.3 months. Enrollment is ongoing, and a decision on a
potential path forward in the 2nd-line plus setting will be made in
2024.
Monotherapy dataGiven the limited options for
heavily pre-treated patients with recurrent/metastatic HPV16+ head
and neck cancers, HOOKIPA continues to evaluate HB-200 as
monotherapy among these patients in the ongoing Phase 1/2 trial.
Follow-up data show HB-200 monotherapy demonstrated a preliminary
median overall survival of 14.2 months in the intent-to-treat
population, indicating potential for prolonged clinical benefit in
this heavily pre-treated population. These data are based on 11
patients who received HB-200 as monotherapy at the same dose being
evaluated in combination with pembrolizumab, with a median
follow-up period of 12.8 months. Additional patients are also being
followed to continue to assess median overall survival in a larger
cohort.
ImmunogenicityImportantly, new follow-up data
from heavily pre-treated patients show an association between the
induction of unprecedented levels of functional T cells after
treatment with HB-200 monotherapy and clinical benefit. T cell
increases were rapid and sustained for at least 8 months, as of
data cut-off. Patients who achieved disease control after treatment
with HB-200 monotherapy generally had greater CD8+ T cell
infiltration in tumors compared to patients whose disease
progressed, suggesting an association of HB-200-induced T cells and
clinical benefit.
Safety and tolerability profileResults from the
Phase 1/2 study showed that HB-200 was generally well tolerated
among 132 patients treated. The safety profile was similar for
patients who received HB-200 monotherapy or HB-200 in combination
with pembrolizumab. This favorable tolerability profile highlights
the potential of HB-200 – and arenaviral immunotherapies in general
– to be combined with other immunotherapies where tumor
antigen-specific T cells are needed. Only seven percent of patients
showed serious adverse events related to the treatment with HB-200.
Only two percent of patients discontinued due to such events.
Webcast: HOOKIPA will host a
live webcast on June 1, 2023 at 8:00 a.m. EDT. Joern Aldag, Chief
Executive Officer, Katia Schlienger M.D., Ph.D., Chief Medical
Officer, and Klaus Orlinger, Ph.D., Chief Scientific Officer will
provide an overview of the HB-200 data and future plans for
HOOKIPA’s oncology program. Alan Ho, M.D., Ph.D., a study
investigator, will also offer commentary on the unmet medical need
for patients with head and neck cancer.
Dial In: +1 646 876 9923UK Dial In: +44 208 080
6591Austria Dial In: +43 72 011 5988Webinar ID: 899 3030
4628Webcast: Link
The webcast and the presentation will be
available within the Investors & Media section of HOOKIPA’s
website at https://ir.hookipapharma.com/events. An archived replay
will be accessible for 30 days following the event.
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. HOOKIPA anticipates sharing an
additional data update at an upcoming medical conference.
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 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
March 31, 2023, 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:
Media Instinctif
Partners hookipa@instinctif.com
+44 (0) 7457 2020 |
InvestorsReinhard KanderaChief Financial
OfficerIR@hookipapharma.com |
1 Harrington et al. Pembrolizumab With or
Without Chemotherapy in Recurrent or Metastatic Head and Neck
Squamous Cell Carcinoma: Updated Results of the Phase III
KEYNOTE-048 Study. Journal of Clinical Oncology.
2023;41(4);790-802.
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