HOOKIPA presents complete HB

  • Phase 1 data show that single-vector HB-201 and 2-vector HB-202/HB-201 were generally well tolerated, rapidly induced tumor-specific T cells, and anti-tumor activity in heavily pretreated head and neck cancer patients showed
  • Poster presentation of data to support the recommended phase 2 dose for alternating 2-vector HB-202/HB-201 and phase 2 development schedules in head and neck cancer

NEW YORK and VIENNA, Austria, May 26, 2022 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. (HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary Arenavirus platform, announced today announced that HB-200 Phase 1 results (NCT04180215) for single-vector HB-201 and alternating 2-vector HB-202/HB-201 in patients with advanced human papillomavirus 16-positive (HPV16+) cancer, including those recommended Phase 2 dose for HB-202 /HB-201, will be presented in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3-7, 2022. Data as of March 31, 2022 are presented on 68 patients, 54 of whom had head and neck squamous cell carcinoma (HNSCC).

We look forward to presenting the complete Phase 1 data results from our HB-200 program at ASCO. The final analysis shows that HB-201 and the 2-vector HB-202/HB-201 were generally well tolerated and demonstrated antitumor activity in these difficult-to-treat patients. We will also share additional translational data that continue to show robust tumor-specific T cell responses using our HB-200 therapiessaid Jörn Aldag, Chief Executive Officer at HOOKIPA. “We continue to advance this truly novel science through the clinic, and the insights from this phase help deepen our understanding of the potential of our technology. These findings inform our journey as we advance the 2-vector HB-202/HB-201 immunotherapy into the ongoing Phase 2 HNSCC portion of the trial, as well as our approach to our HB-300 program in prostate cancer.”

The summary is available on the ASCO website with the key details below:

  • Recommended phase 2 dose (RP2D) of HB-200 arenavirus-based cancer immunotherapies in patients with HPV16+ cancer
    • Summary No. 2517, Developmental Therapeutics – Immunotherapy
      • Poster Session: Sunday, June 5, 8:00 a.m. – 11:00 a.m. CDT
      • Poster Discussion: Sunday, June 5, 11:30 a.m. – 1:00 p.m. CDT in Hall D2
  • Presenter: Siqing Fu, MD, Ph.D., Professor of Investigational Cancer Therapeutics and Principal Investigator at the University of Texas MD Anderson Cancer Center
  • Key Findings:
    • Single-vector HB-201 and 2-vector HB-202/HB-201 immunotherapies were generally well tolerated and demonstrated antitumor activity in heavily pretreated HPV16-positive head and neck cancer patients
    • HB-201 was evaluated for safety, efficacy, and immunogenicity at three dose levels with two dosing schedules and two routes of administration
    • HB-202/HB-201 was evaluated for safety, efficacy and the recommended Phase 2 dose at four doses and two routes of administration
    • Anti-tumor activity in this heavily pretreated patient population was observed with HB-201 and HB-202/HB-201 treatments alone, including sustained tumor control and partial response.

About HB-202/HB-201
HB-201 and HB-202/HB-201 are HOOKIPA’s lead oncology candidates developed using the company’s proprietary replicating arenavirus vector platform. HB-201 is a single vector compound that uses lymphocytic choriomeningitis virus as an arenaviral backbone. HB-202 is a single vector compound that uses Pichinde virus as the arenavirus backbone. Both express the same antigen, an HPV16-derived E7E6 fusion protein. HB-202/HB-201 is a 2-vector alternating immunotherapy designed to further focus the immune response against the target antigen. In preclinical studies, the alternating administration of HB-201 and HB-202 resulted in a 10-fold increase in immune response and better disease control than either compound alone. Both novel immunotherapy candidates received fast track designation for the treatment of 1 in combination with pembrolizumab from the U.S. Food and Drug AdministrationSt-line advanced/metastatic HPV16+ head and neck cancer.

About the HB-200 process (NCT04180215)
This Phase 1/2 clinical trial is an open-label study evaluating different doses and dosing regimens in people with treatment-refractory HPV16+ head and neck cancer who have progressed with standard of care, including checkpoint inhibitors. The HB-200 study is evaluating two HOOKIPA compounds: HB-201 as a single-vector therapy, HB-202/HB-201 as an alternating 2-vector therapy, and both in combination with a PD-1 inhibitor. The primary endpoint of Phase 1 is a recommended Phase 2 dose. Secondary endpoints include safety and tolerability and preliminary efficacy per RECIST 1.1. The study also includes exploratory targets on T cell response and pharmacodynamic biomarkers.

The Phase 2 portion of the study is open-label with a primary endpoint of preliminary anti-tumor activity, as defined by RECIST 1.1, for objective response rate and disease control rate. Secondary endpoints including safety, overall survival, progression-free survival and duration of response. Phase 2 is ongoing and evaluating HB-201 in combination with pembrolizumab in 1St— and 2nd-Line plus settings, with additional arms planned based on final Phase 1 results.

About human papillomavirus-related cancers
Human papillomavirus, or HPV, is a common viral infection estimated to cause about 5 percent of the global 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 types of HPV that are associated with cancer, HPV16 is the most common cause of cancer. Most HPV infections are cleared from the body with no lasting effects. However, in some cases, HPV DNA becomes integrated into chromosomal DNA. When host cells take up this DNA, they express the HPV proteins E6 and E7. This uptake can potentially lead to cancer, as the expression of these proteins leads to changes in cell cycle control, which in turn predisposes these cells to become cancerous.

HOOKIPA Pharma Inc. (HOOK) is a clinical-stage biopharmaceutical company focused on the development of novel immunotherapies based on its proprietary arenavirus platform designed to mobilize and augment targeted T cells and thereby treat serious diseases to combat or prevent. HOOKIPA’s replicating and non-replicating technologies are designed to induce robust and sustained antigen-specific CD8+ cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its investigational-owned arenaviral immunotherapeutics targeting HPV16+ cancer, prostate cancer, KRAS-mutated cancer (including colon, pancreatic and lung cancer), and other undisclosed programs. Additionally, HOOKIPA aims to develop functional cures for HBV and HIV in collaboration with Gilead.

Learn more about HOOKIPA online at www.hookipapharma.com. For more information please contact:

Forward-Looking Statements

Certain statements in this press release are “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are identified by terms such as “believes”, “expects”, “plans”, “potential”, “would” or similar expressions and the negative of these terms. Such forward-looking statements involve significant risks and uncertainties that could cause HOOKIPA’s research and clinical development programs, future results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the uncertainties inherent in the drug development process, including the early development phase of HOOKIPA programs, the process of designing and conducting pre-clinical and clinical studies, regulatory approval processes, the timing of regulatory filings, the challenges associated with the Manufacturing of pharmaceuticals, HOOKIPA’s ability to successfully establish, protect and defend its intellectual property, risks related to business interruptions resulting from the outbreak of the coronavirus disease (COVID-19) or similar public health crises, the impact of COVID-19 on patient enrollment and timing of clinical results and other matters that could impact the availability 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, and risks associated with the Company’s operations generally, please see HOOKIPA’s Quarterly Report on Form 10-Q for the Quarter ended March 31, 2022 which is available on the Security and Exchange Commission’s website at www.sec.gov and HOOKIPA’s website at www.hookipapharma.com.



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