Hookipa Pharma, a developer of immunotherapeutics based on its proprietary arenavirus platform, has entered a clinical collaboration and supply agreement with Merck USA (known as MSD outside of the US and Canada) to evaluate the combination of HB-200, a novel arenaviral immunotherapeutic, and Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab) as first-line treatment for patients with advanced head and neck squamous cell carcinoma (HNSCC).
“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, CEO 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 has reportedly been initiated based on promising data from the ongoing HB-200 Phase I/II 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% 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. Preliminary data on HB-201/HB-202 therapy showed a disease control rate of 100% (four of four patients). Importantly, the Phase I data on 38 evaluable patients showed the therapy has a favourable safety profile in heavily pre-treated patients with HPV16+ cancers, underlining its potential as a monotherapy and in possible combination with checkpoint inhibitors.
Hookipa anticipates initiating a Phase II trial with HB-200 in combination with KEYTRUDA in 2022. Additional Phase II expansion cohorts are also planned to start in Q1 2022.