HOOKIPA Pharma to Present Positive Clinical Data at ASCO 2024

HOOKIPA Pharma Inc. has announced the presentation of new clinical data from its Phase 1/2 trial of HB-200, combined with pembrolizumab, for the treatment of HPV16-positive head and neck cancers. The data will be shared at the American Society for Clinical Oncology (ASCO) 2024 Annual Meeting on June 4. The company highlighted the promising safety profile and clinical activity of the combination, especially in patients with a PD-L1 combined positive score (CPS) of 20 or higher.

Study Results & Patient Subset Analysis

As of the January 12, 2024 data cutoff, 42 patients had been treated with HB-200 plus pembrolizumab. The treatment was generally well tolerated, with few treatment-related discontinuations and no deaths. Notably, among 17 evaluable patients with CPS ≥20, the confirmed objective response rate (ORR) was 53%, the complete response (CR) rate was 18%, and the disease control rate (DCR) was 82%. These results are significant for the subset of patients who could be eligible for the upcoming pivotal Phase 2/3 trial, set to begin enrollment in the fourth quarter of 2024.

Presentation at ASCO 2024

The detailed findings will be presented during the Head and Neck Oral Abstract Session at ASCO on June 4. The session will also include preliminary data on progression-free survival and overall survival for patients with CPS ≥20.

Joern Aldag, CEO of HOOKIPA, expressed optimism about the results, stating that the data reinforces the company's strategy for the pivotal Phase 2/3 trial. He emphasized the potential of HB-200 to offer a new targeted therapy option for patients with HPV16+ head and neck cancer.

Adverse Events and Safety Profile

Among the 35 evaluable patients, the combination treatment demonstrated a favorable safety profile. Grade 3 or higher treatment-related adverse events (TRAEs) were reported in 14% of patients, serious TRAEs in 7%, and treatment discontinuation due to TRAEs in 5%. There were no treatment-related deaths.

Additional Data on HB-200 and Chemotherapy

In a separate Investigator Initiated Trial (IIT) led by Dr. Ari Rosenberg, the combination of HB-200 and chemotherapy for non-metastatic HPV16+ oropharyngeal cancers (OPC) showed early efficacy signals. In this study, 21 patients received neoadjuvant HB-200/chemotherapy, and deep responses were observed in 81% of patients. Those treated with higher dose levels showed even better responses. This study concluded that the combination is safe and feasible, meriting further investigation.

Preclinical Data on HB-700

HOOKIPA also shared preclinical data on HB-700, an investigational immunotherapy targeting KRAS-mutated cancers. The therapy showed efficient induction of KRAS mutation-specific T cell responses in HLA transgenic mice, capable of targeting and destroying KRAS mutant cells without affecting wild-type KRAS cells. This data supports the initiation of a Phase I study for HB-700 in treating KRAS-mutated cancers.

Conclusion

HOOKIPA Pharma's updated clinical and preclinical data showcase the potential of its proprietary arenavirus-based immunotherapy platform. The positive results from the HB-200 Phase 1/2 trial, combined with pembrolizumab, are particularly promising for advancing treatment options for HPV16+ head and neck cancer. The company's progress with HB-700 for KRAS-mutated cancers also represents a significant step forward in developing targeted immunotherapies. As these trials advance, HOOKIPA aims to provide new therapeutic options for patients battling these challenging cancers.

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