Phase 2/3 pivotal trial design and protocol for HB-200 in combination with pembrolizumab for the 1L treatment of patients with HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma (OPSCC) aligned with FDA feedback
“It has been a dream of mine—and my HOOKIPA colleagues—to translate our science into a product that will make an impact for patients and help them fight cancer and infectious diseases. I am happy to say that we are taking a very big step forward to making this dream a reality,” said Joern Aldag, Chief Executive Officer of HOOKIPA. “We believe our data is best-in-class and puts us in the lead position for OPSCC in the first line setting. We have alignment with the FDA on our pivotal trial design and protocol, as well as PRIME designation for HB-200 in combination with pembrolizumab for the treatment of patients with OPSCC in the first line setting from the European Medicines Agency. We believe our trial design and alignment with our primary regulators can help us reach a potential registration more quickly. Further, we have been accepted for an oral abstract presentation at ASCO in June 2024 where we will present an update from our Phase 1/2 trial with approximately 40 patients treated with the combination of HB-200 and pembrolizumab.”
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