dm+d

Unassigned

New Medicines

Advanced, unresectable or metastatic melanoma - with pembrolizumab

Information

New molecular entity
Scancell
Scancell

Development and Regulatory status

Phase II Clinical Trials
None
None
Yes
Yes
Feb 14FDA grants orphan drug status to SCIB 1 for the treatment of metastatic melanoma [3].

Category

A DNA vaccine candidate, developed using proprietary ImmunoBody® vaccine technology in which, a plasmid DNA, encodes a human IgG1 antibody engineered to express three epitopes from gp100 and a melanoma antigen called tyrosinase-related protein 2 (TRP 2) engineered into its CDR regions and two helper T cell epitopes. Injected with a small, hand-held electroporation device (TriGrid™ delivery system). Four doses given monthly, followed by every 12 weeks, each time as 2 injections in different limbs .
In 2011, the UK age-standardised incidence of melanoma for females was 17.6 (11.7 in 2001) and for males 17.5 (10.1 in 2001) per 100,000 population [1].
Advanced, unresectable or metastatic melanoma - with pembrolizumab
Intramuscular

Trial or other data

Aug 21PII trial (NCT04079166) is recruiting [2].
Aug 19PII trial to evaluate the tumour response rate, progression free survival, and overall survival following the treatment with combination of SCIB 1 and pembrolizumab in patients with metastatic melanoma starts (SCIB1-002; NCT04079166). The trial intends to enroll 44 adults in the UK (at Velindre University NHS Trust, East and North Hertfordshire NHS Trust, Nottingham University Hospitals NHS Trust and Oxford University Hospital NHS Foundation Trust). SCIB1 will be administered with a small, hand-held electroporation device (TriGrid™ delivery system version 2.0 [TDS-IM v2.0]). SCIB1 will be given for up to 85 weeks, in combination with pembrolizumab. After receiving the first dose of SCIB1, the patient will receive SCIB1 at 4, 7, 13 and 25 weeks, then every 12 weeks up to Week 85. Pembrolizumab treatment will be started 1 week after the first dose of SCIB1 and given every 6 weeks. On each occasion, SCIB1 will be given by two injections into a muscle in a different limb, e.g. one into the upper arm and the other into the thigh. Instead of a normal needle and syringe, a small, hand-held electroporation device (TDS-IM v2.0) will be used to inject SCIB1 into the muscles. Collection of primary outcome data (safety and tolerability) is due to complete Dec 23 [2].