Scancell's Cancer Therapies Set to Reach Key Milestones in 2025

Scancell Holdings PLC is gearing up for pivotal cancer trial data in 2025 and larger studies that could lead to regulatory approval. Its lead programme, iSCIB1+, has shown improved progression-free survival in melanoma patients. Interim results for Modi-1 vaccine in head and neck cancer showed a 43% response rate. The company has expanded into antibodies through its GlyMab platform and has a licensing deal with Genmab. Scancell has enough cash to fund operations into the second half of 2026.

Scancell Holdings PLC, a clinical-stage biotechnology company developing targeted off-the-shelf active immunotherapies, has reported significant progress in its efforts to address unmet needs in cancer treatment. The company's lead program, iSCIB1+, has demonstrated improved progression-free survival (PFS) in melanoma patients, while interim results for Modi-1 vaccine in head and neck cancer showed a 43% response rate. Scancell has also expanded into antibodies through its GlyMab platform and secured a licensing deal with Genmab.

The company's latest business update and financial results for the year ended 30 April 2025 highlight its clinical and organizational advancements. The Phase 2 SCOPE trial in advanced melanoma showed that iSCIB1+ in combination with checkpoint inhibitors has the potential to set the new standard for advanced melanoma treatment. The PFS for iSCIB1+ in the target HLA population at 11 months is 78%, comparing favorably against the historic 12-month PFS of 46% reported by doublet checkpoint therapy of ipilimumab and nivolumab. The combined data for the defined HLA target population across Cohorts 1 and 3 shows a 22-month PFS of 69%, representing a meaningful improvement over historic doublet checkpoint therapy Scancell reports Business Update and Financial Results for the Year Ended 30 April 2025^[1].

Scancell's Modi-1, part of the Moditope® platform, has shown early clinical efficacy in head and neck cancer, with a 43% response rate when combined with a single checkpoint inhibitor. The company continues to make progress with Modi-1, with further data expected in renal cell carcinoma later this year. The GlyMab® platform has also received additional validation through a second commercial license with Genmab, with the company establishing GlyMab Therapeutics Limited to hold and develop its antibody assets Scancell reports Business Update and Financial Results for the Year Ended 30 April 2025^[1].

The company's financial results for the year ended 30 April 2025 show an operating loss of £15.0 million, compared to £18.3 million in 2024. The group cash balance at 30 April 2025 was £16.9 million, up from £14.8 million at the same time last year. The company raised gross proceeds of £11.3 million in late 2024 through financing, with participation from both existing and new healthcare specialist investors Scancell reports Business Update and Financial Results for the Year Ended 30 April 2025^[1].

Scancell's leadership team has been significantly strengthened through key appointments, including Dr. Phil L'Huillier as Chief Executive Officer and Dr. Nermeen Varawalla as Chief Medical Officer. The company's CEO commented on the progress made and the future outlook, stating, "Scancell is making strong clinical and organizational progress, meeting its commitments and building momentum towards near-term developmental milestones. Our DNA ImmunoBody® iSCIB1+ has shown significant potential to address the unmet needs of advanced melanoma patients, with a clinically meaningful improvement on progression-free survival over standard of care, with excellent tolerance. We are now accelerating preparations for randomized studies on the path to registration to start in 2026 and are in active discussions with potential partners on future development. We continue to make good progress with Moditope® Modi-1, achieving early clinical validation in head and neck cancer, with further data in renal cell carcinoma expected later this year. The innovative GlyMab® platform has received additional validation through a second commercial license with Genmab and we have now established GlyMab Therapeutics Limited, a wholly owned subsidiary, to bring focus and strategic optionality as we look to unlock further value in these antibodies. We are determined to realize the potential of our active immunotherapies for patients on our mission towards a cancer-free future" Scancell reports Business Update and Financial Results for the Year Ended 30 April 2025^[1].

Scancell's future development plans include further iSCIB1+ cohort 3 data and initial Cohort 4 data in Q4 2025, as well as randomized studies on the path to registration anticipated to begin in 2026. The company continues to assess partnering or out-licensing options for clinical stage assets and GlyMab Therapeutics Ltd. Scancell has a cash runway through to the second half of 2026, with further upside opportunities Scancell reports Business Update and Financial Results for the Year Ended 30 April 2025^[1].

Scancell's progress and strategic initiatives position the company well for future development and potential regulatory approval. The company's focus on clinical data, commercial partnerships, and organizational capabilities is evident in its recent achievements and future plans. Investors and financial professionals should closely monitor Scancell's progress as it continues to advance its innovative immunotherapies towards a cancer-free future.