Scancell positions iSCIB1+ for pivotal melanoma trial as data and manufacturing scale-up accelerate

Scancell Holdings faces a pivotal 18 months as it advances plans for a large, registrational study of iSCIB1+, an off‑the‑shelf DNA vaccine for melanoma, after a year of supportive clinical and operational progress.

House broker Panmure Liberum and management said the company is already in talks with regulators in the United States, Europe and the UK on the design of a pivotal trial, with formal feedback expected before the end of 2026. The broker expects the study to recruit more than 450 patients and to test iSCIB1+ against the current double immunotherapy standard of nivolumab and ipilimumab, with progression‑free survival likely to be the primary endpoint.

The regulatory planning follows July’s SCOPE data, which analysts described as a strong endorsement of Scancell’s DNA vaccine approach. In the trial’s first cohort, progression‑free survival extended to 22 months. When cohorts one and three were combined, the objective response rate reached 69 percent and disease control 88 percent. Cohort three, which combined iSCIB1+ with Bristol Myers Squibb’s nivolumab and ipilimumab, produced a progression‑free survival rate of 80.8 percent at 11 months. Safety data reported to date have shown a clean profile, according to the company and its advisers.

Scancell and Panmure have highlighted the commercial and practical advantages of an off‑the‑shelf design. Unlike personalised vaccines, which must be manufactured individually for each patient, iSCIB1+ follows a standardised manufacturing process that could enable faster production, lower costs and broader patient access if clinical efficacy is confirmed.

Preparations for a large trial are underway. Scancell has scaled up manufacturing capacity, engaged in discussions with contract research organisations and opened a fourth SCOPE cohort to test alternative dosing schedules and intradermal delivery. Results from that cohort are expected later in 2025. The company also cited the UK’s NHS Cancer Vaccine Launch Pad as a potential recruitment conduit to accelerate patient enrolment.

Scancell’s pipeline extends beyond iSCIB1+. Modi‑1, another off‑the‑shelf cancer vaccine, is in clinical development for several solid tumours; management has said kidney cancer data are expected in summer 2026 and head and neck cancer results later in 2025. The company is also developing GlyMab, an antibody platform, and plans to spin it out into a separate vehicle to attract partners and reduce internal headcount by about 25 staff. Two GlyMab assets have already been licensed to Genmab, which provided roughly $5 million upfront per asset and potential milestone payments reported by the company at more than $600 million apiece. The lead GlyMab programme, SC134, is being developed for small‑cell lung cancer.

Management has cited potential market sizes of $7.5 billion for the melanoma opportunity and $3 billion for Modi‑1’s indications, while Panmure and the company caution that those figures represent market size estimates rather than company revenue forecasts.

Despite the clinical progress and corporate deals, Scancell’s share price has drifted, reflecting investor caution common in small‑ and mid‑cap biotechnology stocks where clinical risk and long development cycles weigh on valuations. Upcoming catalysts include the regulator feedback expected in 2026, the fourth SCOPE cohort readout later in 2025 and the sequence of Modi‑1 and GlyMab milestones through 2026. Analysts and investors will be watching whether the planned pivotal study design, manufacturing scale‑up and recruitment pathways can be aligned to support a registrational programme for iSCIB1+.