On April 25, 2024 HOOKIPA Pharma Inc., a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported its final pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab (Press release, Hookipa Biotech, APR 25, 2024, View Source [SID1234642344]). 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.

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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.

The Company also announced acceptance of its HB-200 study abstract as an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 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.

"It 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 (Free ASCO Whitepaper) 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 trial will treat patients with HPV16+ recurrent/metastatic PD-L1 CPS ≥ 20 oropharyngeal squamous cell carcinoma in the first line setting.
The trial is expected to enroll approximately 250 patients across the seamless Phase 2/3 design.
Patients will be randomized one-to-one for HB-200 plus pembrolizumab or placebo plus pembrolizumab.
The primary endpoints are objective response rate for the Phase 2 portion and overall survival for the Phase 3 portion.
The Company may seek accelerated approval based on data from the Phase 2 portion of the trial, from approximately half of the Phase 2/3 study patients, if favorable.
Phase 2 primary analysis expected in 2026 with potential subsequent filing for accelerated approval.
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.

Call Details:
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 (Free ASCO Whitepaper) 2024 Annual Meeting

HB-200:
Title: 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 investigator
Abstract Type: Oral abstract
Session Name: Head and Neck Cancer
Session Date and Time: June 4, 2024; 9:45 AM-12:45 PM CDT
Abstract Number: 6005

Title: Neoadjuvant HPV16-specific arenavirus-based immunotherapy HB-200 plus chemotherapy followed by response-stratified de-intensification in HPV16+ oropharyngeal cancer: TARGET-HPV
Presenter: Dr. Ari Rosenberg, Principal Investigator, TARGET-HPV Trial, University of Chicago Medicine
Abstract Type: Rapid oral abstract
Session Name: Head and Neck Cancer
Session Date and Time: June 3, 2024; 8:00 AM-9:30 AM CDT
Abstract Number: 6017
Trial Sponsor: UChicago Medicine

HB-700
Title: Development of an arenavirus-based immunotherapy for treatment of KRAS mutant cancer
Abstract Type: Abstract only
Session Date: May 23, 2024
Abstract Number: e14672

About HB-200
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 alone.