Company News: ISA Pharmaceuticals Initiates Phase I/II Clinical Trial With ISA101 in Women with Cervical Cancer

– Therapeutic vaccine against Human Papilloma Virus type 16 (HPV16) tested together with chemotherapy in women with HPV16-positive advanced or recurrent cervical cancer –

ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced the initiation of a Phase I/II clinical study of its lead candidate ISA101 in women with HPV16-positive advanced or recurrent cervical cancer, eligible for standard chemotherapy with carboplatin and paclitaxel (CervISA study). The first patient was vaccinated this month.

ISA101 is a synthetic long peptide (SLP®) vaccine for the treatment of diseases induced by human papilloma virus (HPV) type 16, such as cervical cancer, ano-genital premalignant and malignant lesions, and head and neck cancer.

The open-label, multicenter CervISA study is designed to determine the safety and immune-modulating effects of ISA101 at different doses with or without pegylated interferon alpha in combination with carboplatin and paclitaxel.

Patients will receive up to six standard chemotherapy cycles (paclitaxel 175 mg/m2 and carboplatin AUC 6 every three weeks) and three vaccinations at different dose levels during the same period. Half the women at each dose level will also receive pegylated interferon alpha. Primary endpoints of the trial are safety and HPV-specific immune responses. The secondary endpoint is antitumor efficacy according to RECIST 1.1.

Virtually all cervical cancers are caused by HPV infections, with HPV16 being responsible for about 50-60% percent of all cases.