HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapeutics based on its proprietary
arenavirus platform, today announced positive updated results from
its Phase 2 clinical trial of HB-200 in combination with
pembrolizumab in patients with recurrent/metastatic human
papillomavirus 16 positive (HPV16+) head and neck cancer.
The updated data presented at the ASCO 2024
Annual Meeting is as of March 29, 2024 (cutoff date) and includes
46 patients treated with HB-200 plus pembrolizumab in the first
line setting. Results showed rapid and durable activation of
antigen-specific CD8+ T cells and promising clinical activity.
Among 35 evaluable patients data showed a 37
percent confirmed objective response rate (ORR), 11 percent
complete response (CR) rate, and 69% disease control rate (DCR),
per RECIST 1.1 criteria. Duration of response was not yet mature
with 62 percent of responders still on treatment as of the cutoff
date.
In a subset of 17 evaluable patients with CPS of
20 or higher, the updated data showed a 53 percent confirmed ORR,
18 percent CR rate, and 82 percent DCR. These patients are
representative of the Company’s planned pivotal Phase 2/3 trial
population, which is targeted to begin enrolling patients in the
fourth quarter of 2024.
Additionally, preliminary PFS for the CPS 20 or
higher subgroup was 16.3 months and is encouraging based on the
historical PFS data of 3.4 months reported for pembrolizumab
alone1. The preliminary OS rate was 88% at 9 months, and median OS
was unreached as of the cutoff date with 16 of 19 patients still
alive. Median follow-up for these patients was 8.4 months.
“Based on the evidence from the Phase 2 trial of
HB-200 plus pembrolizumab, I am encouraged by the potential this
immunotherapy combination may provide as a targeted therapeutic
option for HPV16+ head and neck cancer patients,” said Dr. Alan Ho,
Head and Neck Oncologist at Memorial Sloan Kettering Cancer Center
and a trial investigator. “The data show that this combination has
been generally well-tolerated and can likely increase immunogenic
tumor cell death, leading to improved response rates and potential
durability.”
“HPV16+ disease is a unique indication that
requires a patient-centric and targeted therapeutic approach.
HB-200 plus pembrolizumab has shown to be a potentially powerful
combination that has consistently delivered positive outcomes for
our patients,” said Joern Aldag, Chief Executive Officer of
HOOKIPA. “Among published data in HPV+ disease, HOOKIPA has a
best-in-class asset with the HB-200 combination. We also have
alignment on a clinical development strategy with the U.S. Food and
Drug Administration with a path to potential accelerated approval.
Importantly, our pivotal seamless Phase 2/3 trial is just the
beginning—our platform continues to demonstrate the potential power
of arenaviral-based immunotherapies to help provide targeted
treatments for patients across disease areas and indications.”
Call Details: HOOKIPA
HB-200 ASCO Data UpdateTuesday, June 4, 2024, 4:15 p.m.
ETWebcast Registration Dial-in Registration
Results:HB-200 in combination
with pembrolizumab:Data were presented as of March 29, 2024, and
included 46 first line patients with HPV16+, PD-L1 positive,
recurrent or metastatic head and neck squamous cell carcinoma. The
updated data continue to demonstrate a favorable safety profile of
HB-200 in combination with pembrolizumab and promising clinical
activity as a first line treatment.
HB-200 + pembrolizumab was generally well
tolerated. Grade ≥3 treatment-related adverse events (TRAEs) were
reported in 7 (15%) patients, serious TRAEs in 2 (4%) patients, and
TRAEs leading to treatment discontinuation of HB-200 in 2 (4%)
patients. No treatment-related deaths were reported.
Among 35 evaluable patients, 4 confirmed
complete responses, 9 confirmed partial responses, and 11 confirmed
stable disease were observed. Notably, among patients with PD-L1
CPS ≥20 (N=17), ORR was 53% (9/17), complete response rate was 18%
(3/17), and DCR was 82% (14/17). All responses were confirmed per
RECIST 1.1. Preliminary PFS for the CPS 20 or higher subgroup was
16.3 months. The preliminary OS rate was 88% at 9 months, and
median OS was unreached as of the cutoff date with 16 of 19
patients still alive. Median follow-up for these patients was 8.4
months.
Abstract details: ASCO
2024 Annual MeetingTitle: HB-200
arenavirus-based immunotherapy plus pembrolizumab as first-line
treatment of patients with recurrent/metastatic HPV16-positive head
and neck cancer: Updated results
Presenter: Dr. Alan L. Ho, Head and Neck
Oncologist at Memorial Sloan Kettering Cancer Center and a trial
investigatorAbstract Type: Oral
abstractSession Name: Head and Neck
CancerSession Date and Time: June 4, 2024;
9:45 AM-12:45 PM CDTAbstract Number: 6005
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 (LCMV) and pichinde virus
(PICV). 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 and PRIME designation from the European Medicines
Agency for the treatment of first-line HPV16+ recurrent/metastatic
oropharyngeal squamous cell carcinoma. These designations are
supported by preliminary clinical evidence from the Phase 1/2,
open-label, clinical trial (NCT04180215) evaluating safety, T cell
response, and efficacy based on objective response rate (ORR) and
disease control rate (DCR) as defined by RECIST 1.1.
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.
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, KRAS-mutated cancers, and other undisclosed
programs. 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 “anticipates”, “believes,” “expects,” “plans,” “potential,”
“target,” “will,” “would” or similar expressions and the negative
of those terms. Forward-looking statements in this press release
include HOOKIPA’s statements regarding the potential of its product
candidates to positively impact quality of life and alter the
course of disease in the patients it seeks to treat, HOOKIPA’s
plans, strategies, expectations and anticipated milestones for its
preclinical and clinical programs, including the timing of
initiating clinical trials and patient enrollment and the
composition of patient populations for clinical trials, the
availability and timing of results from preclinical studies and
clinical trials, the timing of regulatory filings, the expected
safety profile of HOOKIPA’s product candidates, and the probability
of successfully developing and receiving regulatory approval for
its product candidates, including accelerated approval for HB-200.
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, plans and timelines for the preclinical and clinical
development of its product candidates, including the therapeutic
potential, clinical benefits and safety thereof, the timing,
success and data announcements of current ongoing preclinical and
clinical trials, the ability to initiate new clinical programs, the
risk that the results of current preclinical studies and clinical
trials may not be predictive of future results in connection with
current or future preclinical and clinical trials, including those
for HB-200, HB-700, HB-400 and HB-500, 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, HOOKIPA’s ability to achieve the
expected benefits of its strategic reprioritization 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 Annual Report on Form 10-K for the year ended
December 31, 2023, as well as discussions of potential
risks, uncertainties, and other important factors in HOOKIPA’s
subsequent filings with the Securities and Exchange Commission,
which are available on the SEC’s website at https://sec.gov
and HOOKIPA’s website at www.hookipapharma.com. Except as
specifically noted otherwise, all information in this press release
is as of the date of the release, and HOOKIPA undertakes no duty to
update this information unless required by law.
Availability of Other Information About
HOOKIPAInvestors and others should note that we announce
material financial information to our investors using our investor
relations website, www.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
investors 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 social media channels listed
on our investor relations website.
For further information, please contact:
Investors & Media
Michael Kaiser
michael.kaiser@hookipapharma.com
+1 (917) 984-7537
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