HOOKIPA Pharma Updates Phase 2 Data at ASCO 2024 Annual Meeting

HOOKIPA, a company specialized in developing immunotherapeutics using its proprietary arenavirus platform, has released promising updated data from its Phase 2 clinical trial. The trial investigates HB-200 combined with pembrolizumab in patients suffering from recurrent and metastatic human papillomavirus 16 positive (HPV16+) head and neck cancer. The findings, presented at the ASCO 2024 Annual Meeting, reflect data up to March 29, 2024.

The study encompassed 46 patients who were administered HB-200 along with pembrolizumab in a first-line treatment setting. The primary results indicate a rapid and sustained activation of antigen-specific CD8+ T cells, showing substantial clinical efficacy. In the subset of 35 patients deemed evaluable, key outcomes included a 37% confirmed objective response rate (ORR), an 11% complete response (CR) rate, and a 69% disease control rate (DCR) as per RECIST 1.1 criteria. Additionally, 62% of the responders were still undergoing treatment as of the data cutoff.

A focused analysis of 17 evaluable patients with a PD-L1 combined positive score (CPS) of 20 or higher revealed even more impressive outcomes. This group, which represents the target population for HOOKIPA's forthcoming pivotal Phase 2/3 trial, exhibited a 53% confirmed ORR, an 18% CR rate, and an 82% DCR. The initial progression-free survival (PFS) for these patients was 16.3 months, significantly surpassing the 3.4 months historical data for pembrolizumab monotherapy. The overall survival (OS) rate at nine months was 88%, with the median OS not yet reached as 16 out of 19 patients remained alive. The median follow-up duration for this subgroup was 8.4 months.

Dr. Alan Ho, a leading Head and Neck Oncologist at Memorial Sloan Kettering Cancer Center and a trial investigator, expressed optimism about the combination therapy's potential. He highlighted that the regimen has been generally well-tolerated and could significantly enhance tumor cell death, culminating in improved response rates and durability. Joern Aldag, HOOKIPA's Chief Executive Officer, echoed this sentiment, noting that the HB-200 and pembrolizumab combination has delivered consistently positive outcomes, making it a promising candidate for addressing HPV16+ head and neck cancers.

Safety data from the trial also indicated that HB-200 plus pembrolizumab was generally well-tolerated. Grade 3 or higher treatment-related adverse events (TRAEs) were reported in 15% of the patients, with serious TRAEs in 4% and treatment discontinuations in another 4%. Crucially, no treatment-related deaths were reported.

The data supports the ongoing development of HB-200, which utilizes HOOKIPA's proprietary replicating arenaviral vector platform. This platform involves two single-vector compounds from lymphocytic choriomeningitis virus (LCMV) and pichinde virus (PICV), both encoding an E7E6 fusion protein derived from HPV16. The alternating 2-vector approach aims to intensify the immune response against the targeted antigen.

HB-200 has already achieved Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency for treating first-line HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma. These designations are rooted in preliminary evidence from the ongoing Phase 1/2 trial evaluating safety, T cell response, and efficacy metrics like ORR and DCR.

In conclusion, the updated Phase 2 trial results for HB-200 in combination with pembrolizumab are encouraging, displaying notable clinical efficacy and tolerability in treating HPV16+ head and neck cancer. With the planned pivotal Phase 2/3 trial on the horizon, HOOKIPA is poised to further validate these findings and potentially offer a new targeted therapeutic option for patients.

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