ISA Pharmaceuticals to Present First Clinical Trial Data of ISA101b and Libtayo® in Head and Neck Cancer

ISA Pharmaceuticals, a clinical-stage biotechnology company developing immunotherapies to treat cancers and serious infectious diseases, today announces that it will present the first clinical data of the combination of ISA101b and Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with recurrent metastatic Human Papilloma Virus type 16 (HPV16) induced head and neck cancer who progressed on pembrolizumab or nivolumab.

Patients with recurrent and/or metastatic HPV16 positive OPC who experienced disease progression during or within 6 months after prior anti-PD1 therapy were to be treated until disease progression or withdrawal. Patients that never responded to prior treatment were also included. Further information can be found on clinicaltrials.gov (NCT04398524). Recruitment in this study is ongoing; results of the complete trial will become available mid-2024.

ISA101b immunotherapy targets human papillomavirus type 16 (HPV16) positive cancers. It induces strong and specific immune responses to the HPV16 virus, and (re-)establishes a powerful and targeted T-cell immune response against infected and/or cancerous cells and tissues. Re-ignition of an anti-tumor effect of anti-PD1 therapy after failure of checkpoint inhibition by the addition of a therapeutic vaccine is a unique feature.

Head-and-neck cancer can be a severe and life-threatening disease. HPV16 is a major cause of head-and-neck cancer. Recurrent and metastatic HPV16 positive OPC is a form of head-and-neck cancer with a high unmet medical need. In September 2021 ISA101b was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent and metastatic HPV16 positive OPC.