Company News: ISA Pharmaceuticals’ ISA101 Studied in Phase II Combination Trial with Checkpoint Inhibitor Nivolumab

Trial in patients with HPV16-positive, incurable solid tumors initiated by MD Anderson Cancer Center in collaboration with ISA and Bristol-Myers Squibb

ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced the start of a Phase II combination trial, which will be conducted at The University of Texas MD Anderson Cancer Center (Houston, TX).

The goal of the open-label Phase II study is to investigate whether a combination of ISA101 with Nivolumab can help to control cancer that has spread in the body. The safety of the study drugs will also be evaluated. Nivolumab, a PD-1 immune checkpoint inhibitor, is marketed by Bristol-Myers Squibb as Opdivo for the treatment of various cancers.

The study will enroll approximately 28 patients with HPV16-positive, incurable solid tumors. Patients will receive three subcutaneous administrations of ISA101 at three week intervals, and Nivolumab intravenously every 2 weeks, beginning on day 8 after receiving the first ISA101 dose.

The primary endpoint of the study is overall response rate (ORR) at 11 weeks, defined as the sum of patients with complete response (CR) and partial response (PR) divided by the number of evaluable subjects at 11 weeks from start of treatment. RECIST 1.1 criteria will be used for assessment. Further details of the study can be found at The study is expected to be completed in late 2018.

Funding is being provided in part by MD Anderson’s Moon Shots Program, which was launched in 2012 to dramatically improve survival for patients diagnosed with several types of cancer over the next decade. Additional funding for the trial comes from the Stiefel Oropharyngeal Research Fund in support of MD Anderson’s Oropharynx Program, which treats and conducts research on cancers that occur in the portion of the throat behind the mouth.

The trial is open to all HPV16-related cancers regardless of organ of origin.