Full Press Release Details
HOOKIPA Pharma Announces Pivotal Phase 2/3
Trial Design for HB-200 in Combination with Pembrolizumab
NEW YORK and VIENNA,
April 25, 2024 - HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA or the Company), a company developing a new class of immunotherapeutics
based on its proprietary arenavirus platform, today announced its final pivotal Phase 2/3 trial design for HB-200 in combination with
pembrolizumab. The Phase 2/3 trial design and protocol are based on alignment with the U.S. Food and Drug Administration (FDA) following
the Company's Type C meeting with the FDA.
The seamless Phase 2/3
trial is for the investigational product HB-200 in combination with pembrolizumab for the treatment of patients with Human Papillomavirus
16-positive (HPV16+) recurrent/metastatic PD-L1 CPS 20 oropharyngeal squamous cell carcinoma (OPSCC) in the first line setting. The
Company anticipates the first patient will be enrolled in the fourth quarter of 2024.
Company also announced acceptance of its HB-200 study abstract as an oral presentation at the American Society of Clinical Oncology (ASCO)
2024 Annual Meeting in the head and neck cancer session to be held on June 4, 2024. The presentation will include data for approximately
40 head and neck cancer patients treated with HB-200 in combination with pembrolizumab.
has been a dream of mine-and my HOOKIPA colleagues-to translate our science
into a product that will make an impact for patients and help them fight cancer and infectious
diseases. I am happy to say that we are taking a very big step forward to making this dream a reality," said
Joern Aldag, Chief Executive Officer of HOOKIPA.
"We believe our data is best-in-class and puts us in the lead position for OPSCC in
the first line setting. We have alignment with the FDA on our pivotal trial design and protocol, as well as PRIME designation for HB-200
in combination with pembrolizumab for the treatment of patients with OPSCC in the first line setting from the European Medicines Agency.
We believe our trial design and alignment with our primary regulators can help us reach a potential registration more quickly.
Further, we have been accepted for an oral abstract presentation at ASCO in June 2024 where we will present an update from our Phase
1/2 trial with approximately 40 patients treated with the combination of HB-200 and pembrolizumab."
HB-200 in combination with pembrolizumab pivotal
Phase 2/3 trial design summary
The Company will host a conference call today
where HOOKIPA's Executive Team will discuss the full details of the trial design, and the Company's clinical development
strategy for oncology.
HOOKIPA HB-200 Phase 2/3 Clinical Trial Update
Thursday, April 25, 2024, 8:00 a.m. ET
Webcast Registration
Dial-in Registration
Abstract details: ASCO 2024 Annual Meeting
arenavirus-based immunotherapy plus pembrolizumab as first-line treatment of patients with recurrent/metastatic HPV16-positive head and
neck cancer: Updated results
L. Ho, Head and Neck Oncologist at Memorial Sloan Kettering Cancer Center and a trial investigator
Abstract Type: Oral abstract
Session Name: Head and
Session Date and Time: June 4,
2024; 9:45 AM-12:45 PM CDT
Abstract Number: 6005
HPV16-specific arenavirus-based immunotherapy HB-200 plus chemotherapy followed by response-stratified de-intensification in HPV16+ oropharyngeal
Rosenberg, Principal Investigator, TARGET-HPV Trial, University of Chicago Medicine
Abstract Type: Rapid
Session Name: Head and
Session Date and Time:
June 3, 2024; 8:00 AM-9:30 AM CDT
Abstract Number: 6017
Trial Sponsor: UChicago
of an arenavirus-based immunotherapy for treatment of KRAS mutant cancer
Abstract Type: Abstract
Session Date: May 23,
Abstract Number: e14672
HB-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. and iRECIST. As
presented at the European Society for Medical Oncology Annual Congress 2023, HB-200 in combination with pembrolizumab showed a 42 percent
confirmed ORR and disease control rate DCR of 74 percent across 19 evaluable patients, doubling the 19 percent ORR for pembrolizumab
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, KRAS-mutated cancers, and other unnamed indications. 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
release contains 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,"
"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 expectations regarding the design and protocol
of the Company's upcoming pivotal Phase 2/3 clinical trial of HB-200 in combination with pembrolizumab, the timing of patient enrollment
in clinical trials and the availability of data therefrom, and the timing o submissions concerning regulatory approval, and other statements
that are not historical fact. 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 results of preclinical studies and clinical trials may not be predictive
of future results in preclinical studies or 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 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 http://hookipapharma.com/.
In addition, any forward-looking statements represent HOOKIPA's views only as of today and should not be relied upon as
representing its views as of any subsequent date. HOOKIPA explicitly disclaims any obligation to update any forward-looking statements.
No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
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