Scancell Holdings (SCLP) , a developer of immunotherapies for the treatment of cancer, announced its final results for the year ended April 30, 2024 plus a post-period update.
Scancell's lead cancer vaccine SCIB1 saw positive data from the first stage of its Phase 2 SCOPE trial for advanced melanoma, with an objective response rate exceeding the 70% target set for continuation of the study. The trial also added an additional cohort for iSCIB1+, a next-gen variant suitable for a broader patient population.
Full cohort data with SCIB1 and iSCIB1+ is expected in Q4 2024 and H1 2025 respectively. Additionally, a Phase 2/3 registration study in advanced melanoma is planned for 2025, supported by strategic guidance from key stakeholders.
Scancell's other main asset, the Modi-1 vaccine, completed dose escalation and safety cohorts of the Phase 1/2 'ModiFY' study, and continues in the expansion cohorts. Early data showed good safety and ability to induce stable disease for long periods. A cohort in advanced RCC patients evaluating Modi-1 was approved and added to the ModiFY study, with an early clinical read-out expected in H1 2025.
Financially, SCLP reported an operating loss for the 12-month period to April 30, 2024 of £18.3m, an increase from last year due to higher investment in its vaccine and antibody platforms. Financing in late 2023 raised gross proceeds of £11.9m, boosting the group's cash balance to £14.8m as of April 30, 2024, with cash runway through to calendar Q3 2025 beyond expected near-term clinical milestones.
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Scancell reports significant clinical progress across its portfolio in the rapidly growing sector of cancer immunotherapy, with both lead assets set for major milestones over the next 18 months. Scancell's flagship SCIB1 for advanced melanoma saw 11 out of 13 patients achieving at least a partial response in the first stage of its Phase 2 study, exceeding the study's target.
Simultaneously, the next-gen version of the vaccine, iSCIB1+, was added as an additional cohort. The programme promises to become the new standard for first-line treatment of unresectable melanoma and one of the world's first off-the-shelf cancer vaccines - a major potential milestone and value inflection point for Scancell. Investors can look forward to a pivotal Phase 2/3 registration study in 2025, supported by guidance from stakeholders.
Scancell's other lead candidate Modi-1 likewise saw substantial development during the period, including the addition of a RCC cohort with checkpoint inhibitors. For its remaining assets, the group continued to seek partners, having signed post-period an agreement with a major biotech to exclusively evaluate an antibody in SCLP's GlyMab portfolio, receiving $1m in July 2024.
The financing in late 2023 raised a total of £11.9m, leaving the company funded through Q2 2025, beyond the data readout from SCIB1's Phase 2 SCOPE trial and early data from the new renal cohort of the ModiFY trials.
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