ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, 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 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 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 antitumour 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.

“This is the second trial that we have initiated with our lead product this year,” said Jan Fagerberg, Chief Medical Officer of ISA Pharmaceuticals. “In this trial, we are exploring ISA101 with or without interferon in combination with chemotherapy. We expect increased and more robust immunological responses against HPV16, hopefully leading to improved clinical efficacy as compared to chemotherapy alone. We have already seen synergies between SLP vaccinations and chemotherapy in HPV16 animal tumour survival models. Moreover, after treatment with carboplatin-paclitaxel, stronger specific T-cell responses after vaccination with ISA101 have been observed in a pilot study in women with cervical cancer.

Source: ISA Pharmaceuticals