“Our collaboration with Merck & Co., Inc., Kenilworth, NJ., USA, a proven immuno-oncology leader, is an important step as we advance our HB-200 program for the treatment of Human Papillomavirus 16-positive (HPV16+) cancers and seek to introduce a new class of immunotherapeutics,” said Joern Aldag, chief executive officer at Hookipa. “There remains considerable unmet treatment need for people with metastatic head and neck cancers, and we believe the combination of HB-200 and Keytruda may offer hope. We have seen encouraging early responses in heavily pre-treated patients with the addition of Keytruda in our ongoing HB-200 trial. We are excited to explore the potential benefit of HB-200 as a first-line treatment in combination with Keytruda, a leading anti-PD-1 inhibitor globally, and the possibility of making a meaningful impact on patients’ lives.”
The collaboration was initiated based on promising data from the ongoing HB-200 Phase 1/2 clinical trial (NCT04180215) in advanced HPV16+ cancers. As reported at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, 15 patients with metastatic head and neck cancers were eligible for the efficacy analysis, as of data cut-off. HB-201 monotherapy showed an 18 percent overall response rate and median progression-free survival of 3.45 months in heavily pretreated head and neck cancer patients, better than current 2nd-line treatment.
In addition, preliminary data on HB-201/HB-202 therapy showed a disease control rate of 100 percent (4/4 patients). Importantly, the Phase 1 data on 38 evaluable patients showed that HB-200 therapy has a favorable safety profile in heavily pre-treated patients with HPV16+ cancers, underlining its potential as a monotherapy and in possible combination with checkpoint inhibitors.
With a HB-200 program data read-out anticipated by Q4 2021, Hookipa anticipates initiating a Phase 2 trial with HB-200 in combination with Keytruda in 2022. Additional Phase 2 expansion cohorts are also planned to start in Q1 2022.