Clinical-stage biopharmaceutical company Scancell Holdings plc (AIM: SCLP) has shared promising results from the initial stage of its Phase 2 SCOPE trial involving SCIB1 in combination with checkpoint inhibitors (CPIs) for advanced melanoma. The trial exhibited an 82% objective response rate (ORR) among 11 patients, surpassing the expected 70% ORR. The SCOPE trial aims to enhance ORR in patients with unresectable metastatic melanoma when using CPIs in conjunction with SCIB1.

The vaccine stimulates or strengthens immune responses, subsequently safeguarded within tumors by CPIs. During the first stage, 11 out of 16 stage IV metastatic patients reached the 13-week evaluation, with nine demonstrating an objective response. Reductions in tumor volume ranged from 31% to 94%. As the trial advances into the second stage with an additional 27 patients, the aim is to achieve at least 18 more responses, validating SCIB1's efficacy in combination with doublet therapy.

Furthermore, an amendment to the trial protocol, including a new parallel cohort with double CPIs and iSCIB1+, has been submitted. iSCIB1+ boasts increased potency and a broader patient population. Success in the second phase of the SCOPE trial could pave the way for a phase 2/3 registration program for unresectable melanoma, representing a potential $1.5 billion per annum market.

Scancell anticipates significant results in 2024 from its Modi-1 CPI combination data and promising opportunities from the GlyMab and AvidiMab platforms.

SCOPE is an open-label, multicohort, multicenter Phase 2 study of SCIB1 in patients with advanced unresectable melanoma receiving nivolumab with ipilimumab or pembrolizumab. The study assesses whether SCIB1 can improve the objective response rate (ORR) relative to checkpoint inhibitors alone.

ModiFY is an open-label, multicohort, multicenter adaptive Phase 1/2 trial of Modi-1 in patients with unresectable head and neck, ovarian, triple-negative breast, and renal cancer. The study evaluates the safety and efficacy of Modi-1, both alone and in combination with checkpoint inhibitors.

Scancell is focused on developing innovative medicines to address unmet needs in cancer and infectious disease. The company utilizes technology platforms such as Moditope, ImmunoBody, GlyMab and AvidiMab to build a pipeline of novel products.