On May 26, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that complete 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+) cancers, including the recommended Phase 2 dose for HB-202/HB-201, will be shared in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 (Press release, Hookipa Biotech, MAY 26, 2022, https://ir.hookipapharma.com/news-releases/news-release-details/hookipa-present-complete-hb-200-phase-1-results-and-recommended [SID1234615087]). Data as of March 31, 2022 will be presented on 68 patients, 54 of whom had head and neck squamous cell carcinoma (HNSCC).

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"We look forward to sharing the full Phase 1 data results on our HB-200 program at ASCO (Free ASCO Whitepaper). The final analysis shows that HB-201 and 2-vector HB-202/HB-201 were generally well tolerated and showed anti-tumor activity in these difficult-to-treat patients. We also will share additional translational data that continue to show robust tumor-specific T cell responses from use of our HB-200 therapies," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We are continuing to advance this truly novel science through the clinic, and the learnings from this phase help deepen our understanding of the potential of our technology. These insights inform our path as we advance the 2-vector HB-202/HB-201 immunotherapy into the ongoing Phase 2 HNSCC portion of the study, as well as our approach to our HB-300 program in prostate cancer."

The abstract is available on the ASCO (Free ASCO Whitepaper) website with key details noted below:

Recommended Phase 2 dose (RP2D) of HB-200 arenavirus-based cancer immunotherapies in patients with HPV16+ cancers

Abstract # 2517, Developmental Therapeutics – Immunotherapy

Poster session: Sunday, June 5, 8:00 a.m. – 11:00 a.m. CDT
Poster discussion session: Sunday, June 5, 11:30 a.m. – 1:00 p.m. CDT in Hall D2
Presenter: Siqing Fu, M.D., 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 showed anti-tumor activity in heavily pre-treated patients with HPV16+ head and neck cancer

HB-201 was evaluated at three dose levels, with two dosing schedules and two administration routes for safety, efficacy and immunogenicity

HB-202/HB-201 was evaluated at four dose levels and two administration routes for safety, efficacy, and the recommended Phase 2 dose

Anti-tumor activity in this heavily pre-treated patient population was observed with HB-201 and HB-202/HB-201 treatments alone, including sustained tumor control and partial responses.
About HB-202/HB-201
HB-201 and HB-202/HB-201 are HOOKIPA’s lead oncology candidates engineered with the company’s proprietary replicating arenaviral vector platform. HB-201 is a single-vector compound that uses Lymphocytic Choriomeningitis Virus as its arenaviral backbone. HB-202 is a single-vector compound that uses Pichinde Virus as its arenaviral backbone. Both express the same antigen, an E7E6 fusion protein derived from HPV16. HB-202/HB-201 is an alternating 2-vector immunotherapy designed to further focus the immune response against the target antigen. In pre-clinical studies, alternating administration of HB-201 and HB-202 resulted in a ten-fold increase in immune response and better disease control than either compound alone. Both novel immunotherapy candidates, in combination with pembrolizumab, received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of 1st-line advanced/metastatic HPV16+ head and neck cancers.

About the HB-200 trial (NCT04180215)
This Phase 1/2 clinical trial is an open-label trial exploring different dose levels and dosing schedules in individuals with treatment-refractory HPV16+ head and neck cancers who progressed on standard of care, including checkpoint inhibitors. The HB-200 trial is evaluating two HOOKIPA compounds: HB-201 as 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, as well as preliminary efficacy defined by RECIST 1.1. The trial also includes exploratory objectives on T cell response and pharmacodynamic biomarkers.

The Phase 2 part of the trial is open-label with a primary endpoint of preliminary anti-tumor activity, 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, 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-driven Cancers
Human 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.