UK-based Scancell has reported completion of its Phase I/II clinical trial of SCIB1 with positive results while treating patients with Stage III/IV malignant melanoma.
SCIB1 is the company's first cancer vaccine, which is plasmid DNA designed to encode human antibody molecule engineered to express two cytotoxic T-cell epitopes derived from the melanoma antigens Tyrosinase-Related Protein 2 (TRP2) and gp100 plus two helper T-cell epitopes.
Results of the study suggested safe and tolerable administration of SCIB1 over a dose range of 0.4mg to 8mg.
Patients without tumours experienced stronger immune responses than patients with a detectable tumour, which thereby establishes efficacy of SCIB1 as a monotherapy to treat early stage patients with a small tumour.
At a dose level of 8mg, SCIB1 was observed to have triggered strong immune response in the patients.
Scancell CEO Dr Richard Goodfellow said: “We are pleased that the clinical study report on our SCIB1 Phase I/II clinical trial in patients with melanoma has now been finalised, and will be able to support our US IND submission.
“We are very encouraged by the compelling survival data generated in this study, which now demonstrates a median observation time since trial entry of more than four years for the 16 patients with resected tumours and receiving 2mg / 4mg doses of drug.
“This is supported by our long-term immune analysis that suggests continued dosing of SCIB1 may control disease in resected patients.”
The company is planning to file an investigational new drug (IND) application for SCIB1 in the first half of this year.