clinical studies

overview

Several clinical trials of ISA Pharmaceuticals´ lead compound ISA101 are ongoing or planned in HPV16-positive cancer indications, in particular in patients suffering from cervical cancer and head & neck cancer.

The goals of the company-sponsored CervISA trial have been met. In this study, patients were treated with standard-of-care chemotherapy and precisely timed ISA101. Prolonged overall survival is associated with strong antigen-specific T cell responses, so called high responders. Initial results have been presented at ASCO-SITC and ASCO, a manuscript has been submitted.

At the MD Anderson Cancer Center, the team of Prof. B. Glisson conducted a clinical trial in incurable HPV16-positive cancer patients. In this study, patients were treated with a combination of ISA101 and nivolumab, an anti-PD-1 being developed by Bristol Meyers Squibb. In patients with relapsed head  & neck cancer, the percentage of patients with a meaningful tumor response was twice the rate achieved with nivolumab on its own. Results were published in JAMA Oncology (Massarelli et al. 2018).

To date, combinations with ISA101 were well-tolerated and safe, without increase in serious adverse events compared to chemotherapy or anti-PD-1 alone.

Currently, ISA101 is being studied in combination with cemiplimab (Libtayo®), an anti-PD-1 antibody being developed by Regeneron Pharmaceuticals, in patients with platinum-refractory HPV16-positive oropharyngeal cancer (OPC). This randomized phase 2 trial, performed in close collaboration with Regeneron, has opened in December 2018 and will be conducted at about 50 sites across Europe and the United States. The goal is to improve the percentage of patients benefiting from combination therapy and to improve their chances of long-standing disease control.

If you would like to receive more information about ongoing trials, please send an e-mail to info@isa-pharma.com.

current clinical trials

A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive Oropharyngeal Cancer (OpcemISA)

Study ID: NCT03669718

A blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b.

This study will assess the ability of ISA101b to improve Overall Response Rate (ORR) in subjects with platinum-refractory (i.e. progression on or within 6 months of platinum therapy), HPV16-positive OPC when combined with cemiplimab, an investigational anti-PD-1 antibody being developed by Regeneron Pharmaceuticals. ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16. Trials in HPV16-driven malignancies indicate it has activity in these indications, including oropharyngeal and cervical cancers. Cemiplimab, also known as REGN2810, is in late-stage trials and appears to have similar activity to approved anti-PD-1 antibodies in a number of malignancies.

Hespecta Vaccination in HPV+ Tumors or Malignant Lesions

Study ID: NCT02821494

completed clinical trials

Study of the Therapeutic Vaccine (ISA101/ISA101b) to Treat Advanced or Recurrent Cervical Cancer (CervISA)

Study ID: NCT02128126

Results: Melief et al. 2017 ASCO poster (interim results)

Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors

Study ID: NCT02426892

Results: Massarelli et al. 2018 JAMA Oncology

Therapeutic HPV-16 Vaccination for the Treatment of Anal Dysplasia (VACCAIN-T)

Study ID: NCT01923116

early ISA101 trials