NEW YORK – The National Health Service England said Monday it will expand melanoma patients' access to Scancell's cancer vaccine within a Phase II trial.
In the Phase II SCOPE trial, researchers are evaluating Scancell's DNA cancer vaccines SCIB1 and iSCIB1+ in patients with advanced, unresectable melanoma alongside immunotherapy, either Bristol Myers Squibb's Opdivo (nivolumab) and Yervoy (ipilimumab) or Merck's Keytruda (pembrolizumab). Patients in the trial are tested for tumor HLA positivity to establish if they are HLA-A2, HLA-DR4, HLA-DR7, HLA-DR53, or HLA-DQ6 and determine if they're eligible for treatment with SCIB1. Patients don't have to have a certain HLA type to receive iSCIB1+.
The trial is part of the NHS England's Cancer Vaccine Launch Pad (CVLP), which aims to fast-track eligible cancer patients into studies testing vaccines in nearby hospitals. CVLP will recruit dozens of patients by October into SCOPE, which is to include up to 173 patients across four cohorts.
SCIB1 and iSCIB1+ are DNA vaccines that are taken up into antigen-presenting immune cells and are engineered to cause these immune cells to express the TRP-2 and gp100 epitopes, which occur in pigment-producing melanomas. These immunes cells then train a patient's immune cells to recognize and attack melanoma cancer cells.
"Recent clinical data has demonstrated that our potent, tumor-targeted 'off-the-shelf' cancer vaccine delivers strong efficacy, with the potential for meaningful long-term survival benefits in patients with advanced metastatic melanoma," Scancell Chief Medical Officer Nermeen Varawalla said in a statement. "Our partnership with the CVLP will give patients expedited access to this landmark study and is an important step in accelerating the clinical development of this important new treatment."