HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapeutics based on its proprietary
arenavirus platform, today presented updated data from its ongoing
Phase 2 trial of HB-200 in combination with pembrolizumab in
patients with recurrent/metastatic Human Papillomavirus 16-positive
(HPV16+) head and neck cancer.
The preliminary data presented at the European
Society for Medical Oncology (ESMO) Congress 2023 showed a 42
percent confirmed objective response rate (ORR) and disease control
rate (DCR) of 74 percent across 19 evaluable patients treated with
HB-200 in combination with pembrolizumab in the 1st-line,
checkpoint inhibitor (CPI)-naïve setting, doubling the 19 percent
ORR for pembrolizumab alone1. Best overall response for the
evaluable population included one patient with a confirmed complete
response, seven patients with confirmed partial responses, and six
patients with stable disease. All evaluable patients were alive at
the data cutoff (DCO), and the median follow-up time at DCO was 8.3
months. Median overall survival and progression-free survival data
are still maturing.
Importantly, results showed significant
activation of antigen-specific CD8+ T cells, the body’s primary
driver of tumor killing activity. Out of 17 patients with available
peripheral blood mononuclear cells (PMBC) samples, all patients
showed an increase of tumor antigen-specific circulating HPV16+
CD8+ T cells. These T cell activation data are consistent with
previously reported monotherapy data for HB-200.
“We have observed objective response rate,
disease control rate, and activation of antigen-specific T cells
which demonstrate the potential of the intended mechanism to
stimulate the immune system to combat tumors. We have also observed
generally favorable tolerability to date among the patient
population, supporting the investigational therapy’s potential in
combination settings,” said Dr. Alan L. Ho, Head and Neck
Oncologist at Memorial Sloan Kettering Cancer Center and a trial
investigator.
“We continue to see encouraging results in the
first-line patient setting for our HB-200 trial in combination with
pembrolizumab as we have consistently observed patient responses
that are double the ORR observed in standard of care treatments
alone—reinforcing previously reported data,” said Joern Aldag,
Chief Executive Officer at HOOKIPA. “These results give us great
conviction to proceed with our planned randomized trial.”
Results: HB-200 in combination
with pembrolizumab in the 1st-line setting (NCT04180215)As of the
DCO, August 7, 2023, the updated interim efficacy analysis included
19 evaluable patients with at least two imaging assessments out of
the first 20 patients with HPV16+ recurrent/metastatic head and
neck cancers treated with HB-200 in combination with pembrolizumab
in the 1st-line setting as part of the Phase 2 trial. Of the
intent-to-treat population (n=20) one patient was not evaluable due
to COVID-related death prior to the first tumor scan. All patients
received HB-200 intravenously every three weeks for the first five
doses and every six weeks thereafter. HB-200 is a 2-vector
investigational therapy with alternating administration of
Lymphocytic Choriomeningitis Virus (LCMV), and Pichinde Virus
(PICV) vectors, encoding the same HPV16 E6/E7 antigens.
HB-200 in combination with pembrolizumab
demonstrated promising initial anti-tumor activity with a 42
percent ORR (8 of 19 evaluable patients with confirmed responses by
investigator assessment under RECIST 1.1) among CPI-naïve patients
with 1st-line recurrent/metastatic HPV16+ PD-L1+ head and neck
cancer. These data represent a doubling of the 19 percent ORR
reported for pembrolizumab alone1 and are consistent with
previously reported HB-200 data. Eight patients responded including
one with a confirmed complete response and seven with confirmed
partial responses. Another six patients achieved stable disease
representing a DCR of 74 percent (14 of 19 patients). While
recruitment is ongoing, based on these data, HOOKIPA is preparing
to start a randomized trial of HB-200 in combination with
pembrolizumab as 1st-line treatment of recurrent/metastatic HPV16+
PD-L1+ head and neck cancers in 2024.
ImmunogenicityTumor-specific CD8+ T cell levels
induced by HB-200 in combination with pembrolizumab are
unprecedented and consistent with levels observed with HB-200
monotherapy. Among the 17 patients with available peripheral blood
mononuclear cells (PMBC) samples, all patients showed an increase
in the percent of tumor antigen-specific circulating HPV16+ CD8+ T
cell responses per intercellular cytokine staining analysis. Peak
percentage of antigen-specific circulating HPV16+ CD8+ T cell
responses reached up to 31 percent with a median of 3.36 percent.
Max response on treatment vs. before treatment of systemic HPV-16
E7 and E6 specific T cells measured by ELISPOT showed that the
median fold-increase for these patients’ total tumor specific T
cells was a 451-fold increase over baseline, with the maximal
increase of 4,000-fold.
Safety and tolerability profileResults from the
HB-200 in combination with pembrolizumab in 1st-line patients arm
of the Phase 2 part of the trial showed that HB-200 was generally
well tolerated among 20 patients treated. Two patients (10 percent)
showed serious adverse events related to the treatment with HB-200
or pembrolizumab. Only one patient (5 percent) discontinued due to
a treatment-related adverse event (related to pembrolizumab). The
updated safety profile adds to the previously reported safety and
tolerability data from all 132 patients across all arms of the
trial who received HB-200 monotherapy or HB-200 in combination with
pembrolizumab. This generally favorable tolerability profile
highlights the potential of HB-200—and arenaviral immunotherapies
in general—to be successfully combined with other immunotherapies
where tumor antigen-specific T cell induction is of potential
benefit.
ESMO HB-200 Poster
Presentation
Title: HB-200 Arenavirus-Based
Immunotherapy Plus Pembrolizumab as a First-Line Treatment in
Patients with Recurrent/Metastatic HPV16-Positive Head and Neck
CancerPresenter: Dr. Alan L. Ho, Head and Neck
Oncologist at Memorial Sloan Kettering Cancer Center and a trial
investigatorSession Date: October 22,
2023Poster Board Number: 921PAbstract
Number: 2212
About HB-200HB-200 is HOOKIPA’s
lead oncology candidate engineered with the company’s proprietary
replicating arenaviral vector platform. HB-200 is an alternating
2-vector immunotherapy designed to focus the immune response
against the encoded antigen. It comprises two single-vector
compounds with arenaviral backbones based on LCMV and PICV. Both
encode and express an identical E7E6 fusion protein, comprising
well characterized tumor-specific antigens for HPV16+ cancers.
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 was 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.
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.
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 risk that interim
or preliminary data may differ from final data from 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
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