Gradalis, a US-based clinical-stage biopharmaceutical company, has begun a Phase ll study of its proprietary, personalised cancer vaccine Vigil, in combination with Bristol-Myers Squibb's Opdivo (nivolumab), a monoclonal antibody against programmed death-1 receptor (PD-1) to treat patients with advanced non-small cell lung cancer (NSCLC).
The open label Phase ll study will evaluate the combination of Vigil and nivolumab in advanced or metastatic NSCLC that is progressive on or after one prior platinum-based systemic therapy.
Patients who meet the study eligibility criteria will receive Vigil and nivolumab every two weeks.
The primary end point of the study is objective response rate (ORR) for the combination versus the historical ORR of single-agent nivolumab in this patient population. The study will also monitor the safety and tolerability.
Moreover, patients will be observed for tumour-specific immune response using sequential IFN?-ELISPOT (immune activation) assays to evaluate the functional response of the patient's circulating immune cells to unmodified patient-specific tumour samples, starting at baseline (pre-treatment) and sequentially after treatment.
Gradalis chief medical officer John Nemunaitis said: "Our goal is to demonstrate that Vigil, when combined with a PD-1 immune checkpoint inhibitor such as Opdivo, enhances the immune response, leading to more favourable outcomes, particularly in patients expected to be less responsive to Opdivo."
The company is also conducting several other clinical targets for Vigil using its personalised immunotherapy platform in the treatment of cancer, including Ewing's sarcoma, advanced melanoma and advanced ovarian cancer.
Gradalis noted that a patient's tumour cells are engineered to bring out a systemic T-cell directed immune response when administered to the patient through intradermal injections.
By utilising the patient's own tumour as the antigen source, Vigil is designed to elicit an immune response that is both specifically targeted and largely relevant to each patient's unique tumour antigens.