On November 11, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, "HOOKIPA", the "Company"), a clinical-stage biopharmaceutical company developing next generation immunotherapeutics for the treatment of cancer and serious infectious disease, reported that clinical collaborator Alan Ho, MD, PhD, Chief of the Head and Neck Oncology Service at Memorial Sloan Kettering Cancer Center, presented updated Phase 2 data from a study evaluating eseba-vec in combination with pembrolizumab as front line (1L) therapy in the setting of human papillomavirus type 16 positive (HPV16+) relapsed or metastatic head and neck squamous cell carcinoma (R/M HNSCC) at the 39th Annual Meeting for the Society for Immunotherapy in Cancer (SITC2024), being held in Houston Texas from November 8 – 10, 2024 (Press release, Hookipa Pharma, NOV 11, 2024, View Source [SID1234648083]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The late-breaking poster presentation focused on results from a subset of patients (PD-L1 CPS >20, n=27, with 25 response evaluable patients). The data showed an overall response rate (ORR) of 52% for all eseba-vec doses tested, with a disease control rate (DCR) of 80%, as of the September 30, 2024 data cut-off. While progression free survival (PFS) and overall survival (OS) data are still maturing, preliminary median PFS is greater than 16 months, with a 12-month OS rate of 83%, and 66.7% of confirmed responders ongoing. In addition, the observed clinical activity is supported by a rapid, robust, and durable tumor antigen specific T-cell response. Data are generally consistent for the selected Phase 3 dose level, including a 55% ORR, which is an approximately 2-fold increase compared to historical pembrolizumab monotherapy data. Patients experienced manageable toxicity and a low level of serious treatment related adverse events (7.6%).
"The expanded data presented at SITC (Free SITC Whitepaper) 2024 are encouraging to HOOKIPA. They provide highly consistent proof-of-concept results which suggest that the combination treatment could lead to improved clinical outcomes and survival in patients with HPV16+ R/M HNSCC CPS>20 in the first line setting," said Mark Winderlich, PhD, Chief Research and Development Officer.
Dr. Ho commented, "As a medical oncologist who specializes in head and neck cancers, I am inspired by the results of the expanded eseba-vec/pembrolizumab Phase 2 study because of the potentially clinically meaningful response rate and encouraging PFS and OS data. In addition, the regimen has a manageable safety profile that ensures most patients can maintain treatment."
The late-breaking poster: Eseba-vec (HB-200) plus pembrolizumab as first-line treatment of recurrent/metastatic HPV16-positive head and neck cancer: updated results in PD-L1 CPS ≥20 patients will be available on November 11, 2024 on the HOOKIPA website on the "Scientific Publications" tab of the "Our Science" page.
About Eseba-vec
Eseba-vec (also known as HB-200) is an investigational immunotherapeutic agent being evaluated for HPV16 positive cancers. The first indication for eseba-vec is for the potential treatment of patients with HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma (R/M OPSCC) with a PDL1 CPS of 20 or higher, in combination with pembrolizumab, in the first line (1L) setting. Eseba-vec has received Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency for the treatment of 1L HPV16+ OPSCC. Eseba-vec was developed using HOOKIPA’s proprietary arenavirus platform.