SCIB1 is a cancer vaccine candidate that is being developed for the treatment of melanoma.
SCIB1 is a plasmid DNA which encodes a 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.
SCIB1 is an aqueous solution of plasmid DNA administered by intramuscular injection using the TDS-IM electroporation device (Ichor Medical Systems, Inc.)
Following immunization, the engineered antibody is expressed and taken up by dendritic cells, resulting in the development of immune responses against tumor cells expressing the TRP2 and gp100 antigens.
The major advantage of the Immunobody® technology is that the Fc component of the engineered antibody will be recognized by the high-affinity CD64 receptor present on dendritic cells, leading to a significant enhancement of both the frequency and avidity of the T cell immune response.
The induction of high avidity T cells against TRP-2 and gp100 destroys both primary and metastatic tumors, leading to longer progression-free survival.
July 1, 2019: Scancell announced it is weeks away from enrolling patients into its phase 2 trial of their melanoma drug SCIB1, its lead T-cell boosting immunotherapy, in the UK.
Clinical Trial NCT01138410: A Phase 1/2 Study of a DNA Immunotherapy to Treat Melanoma
The trial is an open-label, non-randomised study to determine the safety and tolerability of four doses of SCIB1 administered intramuscularly using an electroporation device (TDS-IM, manufactured by Ichor Medical Systems, USA).
The study will also assess immune effects and anti-tumor activity in patients with melanoma. The trial is being conducted in patients with both unresected and resected disease.
Patients with Stage III or Stage IV melanoma received up to five doses of the SCIB1 vaccine over a 6 month period.
In addition, some patients are being given long term treatment every 3-6 months for up to 5 years. The results to date have been highly encouraging.
All 20 patients with resected tumors are still alive and only five have progressed. This compares very favorably with data from historical controls.
All patients will receive 5 injections of SCIB1 over 5.5 months.
At the discretion of the investigator, patients may continue to receive SCIB1 at 3-6 month intervals for 5 years.
The study will be conducted at major cancer centers in the UK only and is expected to last for seven years. Patients will be followed up for five years after they have completed the trial.