Several clinical trials of ISA Pharmaceuticals´ lead compound ISA101b 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. The paper titled ‘Strong vaccine responses during chemotherapy are associated with prolonged survival’ has been published in Science Translational Medicine and can be found here.
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 monotherapy. Results were published in JAMA Oncology (Massarelli et al. 2018).
To date, combinations with ISA101b were well-tolerated and safe, without increase in serious adverse events compared to chemotherapy or anti-PD-1 alone.
Currently, ISA101b is being studied in combination with cemiplimab (Libtayo®), an anti-PD-1 antibody being developed by Regeneron and Sanofi. There are three trials ongoing with this combination under our strategic collaboration with Regeneron: two in HPV16-positive oropharyngeal cancer and one in cervical cancer.
If you would like to receive more information about ongoing trials, please send an e-mail to firstname.lastname@example.org.