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.
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