HOOKIPA Pharma Begins Phase 2 Trial of Eseba-vec for Head & Neck Cancer

HOOKIPA Pharma Inc., a clinical-stage biopharmaceutical firm, has announced significant progress in its research efforts focused on treating HPV16+ head and neck cancer. In cooperation with Memorial Sloan Kettering Cancer Center (MSKCC), the first patients have been administered doses in an investigator-initiated trial (IIT) of the immunotherapeutic agent eseba-vec.

This study is spearheaded by Dr. Winston Wong, Head and Neck Oncologist, and Dr. Alan Ho, Chief of the Head and Neck Oncology Service at MSKCC. Designed to evaluate eseba-vec in patients who have minimal residual disease (MRD+) following treatment for HPV-driven head and neck cancer, the trial marks a crucial step forward. The data generated from this study could potentially expand the application of eseba-vec into adjuvant care, addressing a significant unmet need within this patient population.

Dr. Mark Winderlich, HOOKIPA's Chief Research and Development Officer, emphasized the broad potential of eseba-vec across HPV16+ cancers, citing positive Phase 2 data in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). He expressed enthusiasm for exploring eseba-vec as an adjuvant treatment for locally advanced HNSCC. Dr. Winderlich also highlighted the ongoing collaboration with Drs. Wong and Ho and the team at MSKCC, aiming to pave the way for more effective treatments for HNSCC patients.

Malte Peters, CEO of HOOKIPA, highlighted that eseba-vec has shown promising safety and efficacy results, particularly when used in combination with pembrolizumab in HPV+ R/M HNSCC patients. Peters reiterated the company's commitment to expanding eseba-vec's application into adjuvant care and revealed that the company is gearing up to initiate the pivotal AVALON-1 Phase 2/3 study by the end of 2024. Initial results from the IIT are anticipated in 2026.

Dr. Winston Wong noted the potential role of targeted immunotherapeutic agents in treating patients with HPV16+ HNSCC. He pointed out that the combination data from Phase 2 trials with pembrolizumab showed rapid and durable activation of antigen-specific CD8+ T cells and promising clinical response rates. Dr. Wong is optimistic that eseba-vec could become an effective adjuvant treatment option for patients who remain HPV16+ after standard treatment.

The Phase 2 randomized, double-blind, placebo-controlled study (NCT06373380) will focus on disease-free survival as its primary endpoint, with secondary endpoints assessing safety and tolerability. The trial aims to enroll approximately 50 patients.

Eseba-vec, also known as HB-200, is an investigational immunotherapeutic agent designed for HPV16 positive cancers. Its initial focus is on treating 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 setting. The agent has received Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency.

HOOKIPA Pharma Inc., listed on NASDAQ under the ticker HOOK, is devoted to developing next-generation immunotherapeutics based on its proprietary arenavirus platform. The company's product candidates aim to induce specific, robust, and durable CD8+ T cells and antibodies to combat cancers and serious infectious diseases. HOOKIPA's pipeline includes therapies targeting HPV16+ cancers, KRAS mutated cancers, and other targets. Additionally, HOOKIPA has partnered with Gilead to develop therapies aimed at providing functional cures for hepatitis B virus (HBV) and human immunodeficiency virus-1 (HIV-1).