ISCIB1+ MHRA CTA Approval for Ph3 trial

Scancell Receives UK MHRA Clinical Trial Authorization for the Phase 3 Registrational Trial of iSCIB1+ in Advanced Melanoma

Phase 3 registrational study of iSCIB1+ in advanced melanoma to enrol 550 patients across 90 global sites

The authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) approval follows the IND clearance from the U.S. Food and Drug Administration (FDA); additional regulatory submissions in the E.U., Canada and Australia are in progress

Commencement of global registrational Phase 3 trial is expected by the end of 2026 with initial progression-free survival (PFS) data expected in the second half of 2028.

Scancell Holdings plc (AIM: SCLP), a late-stage clinical immuno-oncology company developing active immunotherapies designed to enhance anti-tumor immune responses in difficult-to-treat cancers, announced today that the MHRA has granted a Clinical Trial Authorization (CTA) for the Phase 3 registrational trial of its lead ImmunoBody® iSCIB1+ in patients with advanced melanoma.

The Phase 3 randomized, double-blind, placebo-controlled registrational trial of iSCIB1+ in advanced melanoma has an adaptive trial design and aims to enroll 550 patients with stage III or IV unresectable melanoma, across approximately 90 global sites in the U.S., E.U., U.K., Canada, and Australia. Patients will be randomized 1:1 to receive either 8 mg iSCIB1+ plus ipilimumab and nivolumab or placebo plus ipilimumab and nivolumab. The primary endpoint of PFS is designed to support an accelerated approval with overall survival (OS) as the secondary endpoint, intended to support an application for full approval. The Phase 3 design was informed by the Phase 2 SCOPE trial in which iSCIB1+ in combination with ipilimumab and nivolumab demonstrated sustained PFS of 77% at 22 months, and OS of 87.4% at 18 months.

Dr Phil L'Huillier, CEO of Scancell, said: "Our regulatory strategy continues to build momentum. The MHRA CTA for the Phase 3 trial of our lead asset iSCIB1+ in patients with advanced melanoma is an important milestone bringing us one step closer to delivering iSCIB1+ to patients in a global registrational trial setting."

The Phase 3 trial has received an IND clearance from the FDA in January 2026 and initiation activities will continue and are on track to commence by the end of 2026. Initial PFS data, which could support accelerated approval under our trial design, is targeted for the second half of 2028.

About iSCIB1+

iSCIB1+ is a DNA ImmunoBody® in development for the treatment of melanoma. Administered by needle-free intramuscular injection, iSCIB1+ encodes an antibody targeting the melanoma-associated antigens gp100 and TRP-2, priming high-avidity T cells to generate a robust and durable anti-tumor response. The Phase 2 SCOPE trial, iSCIB1+ in combination with ipilimumab and nivolumab demonstrated a PFS of 77% at 22 months in the target HLA population in first-line advanced melanoma, with no increase in checkpoint inhibitor-related toxicities. iSCIB1+ has been granted Fast Track Designation for the treatment of advanced melanoma from the FDA. The registrational Phase 3 trial of iSCIB1+ in patients with advanced melanoma has received an IND clearance from the FDA and CTA from the UK MHRA, and is expected to begin in the second half of 2026. A Phase 2 trial of iSCIB1+ in patients with neo/adjuvant melanoma is planned for the first half of 2027. iSCIB1+ has demonstrated a favorable safety profile and clinically meaningful activity as a monotherapy in Phase 1 and in combination with checkpoint inhibitors in the Phase 2 SCOPE trial in advanced melanoma.

iSCIB1+ is an investigational medicinal product. It has not been approved by the MHRA, the FDA or any other regulatory authority for the treatment of melanoma or any other indication,

and its safety and efficacy have not been established.

Scancell (LSE:SCLP; www.scancell.co.uk) is a late-stage clinical biotechnology company developing targeted, off-the-shelf, active immunotherapies, generated by the ImmunoBody® and Moditope® platforms, designed to stimulate durable anti-tumor responses. The lead product, iSCIB1+, is a DNA ImmunoBody® that has demonstrated a favorable safety profile and clinically meaningful activity both as a monotherapy, in a Phase 1 trial, and in combination with checkpoint therapies in a Phase 2 trial in patients with melanoma. Modi-1 is a Moditope peptide currently being evaluated in a Phase 2 study in head & neck and renal cancers. In addition, Scancell is advancing a pipeline of high affinity GlyMab® antibodies targeting tumor specific glycans, two of which have been licensed for further development to Genmab A/S, an international biotechnology company and global leader in the antibody therapeutics space.

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