Trinity Delta Successful SCOPE outcome and iSCIB1+ selection

Successful SCOPE outcome and iSCIB1+ selection

Lighthouse | 22 July 2025

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Latest data from the Phase II SCOPE study of SCIB1/iSCIB1+ in advanced melanoma have prompted the selection of next generation iSCIB1+ for future development, with plans for a potentially registrational Phase IIb/III trial now being accelerated based on the strength of the data. iSCIB1+ has the potential to address a much larger patient population (c 80% of advanced melanoma patients vs c 40% for SCIB1) that could be identified via a biomarker, with comparable efficacy to SCIB1, demonstrating improvements on currently achievable outcomes with standard-of-care (SoC).
Cohort 1 (SCIB1) and Cohort 3 (iSCIB1+) of the SCOPE study evaluated the addition of SCIB1/iSCIB1+ to SoC double checkpoint inhibitors (CPIs) nivolumab and ipilimumab over 25 weeks in patients with advanced melanoma. The combined overall response rate (ORR) from these Cohorts, which represent the target patient population, was 68.6% (based on 46 responses in 67 evaluable patients). This compares to CPI doublet therapy (ipilimumab/nivolumab), with an ORR of 48% in the real-world setting. The disease control rate (DCR, ie tumour shrinkage or stable disease) of the combined cohorts was 88.0%, with a complete response (CR) rate of 17.9%. The safety profile of the SCIB1/iSCIB1+ and CPIs combinations were consistent with that of SoC, with no additional toxicities.
Whilst survival data are not yet fully mature, progression-free survival (PFS) at 12-months in Cohort 1 was 64.6%, with PFS at 11-months of 80.8% for Cohort 3, vs SoC doublet CPI nivolumab and ipilimumab with a 12-month PFS of 43.9%. Although data from 9 patients in Cohort 2 (SCIB1 in combination with pembrolizumab) are less relevant given the change in SoC to doublet CPI therapy, data are reported as comparable to Cohorts 1 and 3.
A registrational global Phase IIb/III trial is already being planned, and is now being accelerated following these latest data which confirm that iSCIB1+ can improve efficacy, durability, and immunogenicity, all without adversely impacting safety. Input from the US FDA will be sought ahead of Cohort 4 data (iSCIB1+), which is examining intradermal administration (PharmaJet’s Tropis) and an accelerated dosing regimen; these data are expected around end-2025 and could provide useful insights to optimise the dosing regimen.

Trinity Delta view: The positive latest results from the SCOPE study of Scancell’s “off the shelf” cancer vaccine SCIB1/iSCIB1+ are important for three reasons: (1) data consistently show a clinically meaningful and commercially relevant improvement over currently achievable outcomes; (2) the better efficacy can be achieved without worsening SoC safety and tolerability; and (3) the selection of iSCIB1+ should allow a larger group of patients (c 80% of melanoma patients vs c 40% with SCIB1) to benefit. All these factors suggest that iSCIB1+, the candidate selected for future development, could offer many advantages to patients with advanced melanoma. Planning for a potentially pivotal Phase IIb/III trial is being accelerated based on the data from Cohorts 1 to 3. Our last published Scancell rNPV valuation is £330m, or 32p/share.

Lighthouse

22 July 2025


Price	10.35p
Market Cap	£107.3m
Primary exchange	AIM London
Sector	Healthcare
Company Code	SCLP

Corporate client	Yes

Company description

Scancell is a clinical-stage immuno-oncology specialist that has four broadly applicable technology platforms. Two are therapeutic vaccines, Moditope and ImmunoBody, and two are antibody based, GlyMab and AvidiMab.

Analysts

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

Philippa Gardner
pgardner@trinitydelta.org
+44 (0) 20 3637 5042

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