Drugs / iSCIB1+
last change Aug 2026 re-read 9 days ago

iSCIB1+

Vaccine

Developed for
cutaneous melanoma
Investigated by
Egeen · PPD, Part of Thermo Fisher Scientific · Scancell Ltd

Trials 1

20272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT07815574 Dec 2026 → Dec 2028 expected cutaneous melanoma Scancell Ltd Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 9

DateIssuerRelease
2026-08-19 Scancell Ltd Regulatory Scancell Receives UK MHRA Clinical Trial Authorization for Phase 3 Registrational Trial of iSCIB1+ in Advanced Melanoma scancell.co.uk ↗
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.
2026-04-28 Scancell Ltd Regulatory Scancell Receives FDA Fast Track Designation for iSCIB1+ scancell.co.uk ↗
Scancell Holdings plc (AIM: SCLP), the developer of active immunotherapies to treat cancer, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead ImmunoBody® iSCIB1+ for the treatment of advanced melanoma.
2026-01-26 Scancell Ltd Regulatory Scancell announces FDA clearance of IND application for global Phase 3 trial of iSCIB1+ in advanced melanoma scancell.co.uk ↗
Scancell Holdings plc ( AIM: SCLP ), the developer of active immunotherapies to treat cancer , announces the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a registrational Phase 3 trial of its iSCIB1+ Immunobody® in advanced melanoma, with progression free survival as the agreed surrogate endpoint.
2025-12-09 Scancell Ltd Results Scancell updated Phase 2 data shows continued improvement in progression free survival with iSCIB1+ scancell.co.uk ↗
Updated data in this cohort show progression free survival (PFS) was 74% at 16 months in the target population.
2025-11-07 Scancell Ltd Results Scancell to present positive Phase 2 data on Immunobody ® iSCIB1+ in late-stage melanoma at SITC 2025 scancell.co.uk ↗
2025-07-22 Scancell Ltd Results Scancell reports Phase 2 data showing strongly improved outcomes in Late-Stage Melanoma with its Immunobody ® iSCIB1+ scancell.co.uk ↗
2024-01-17 Scancell Ltd Regulatory MHRA approval to add a third cohort using iSCIB1+ to the SCOPE trial scancell.co.uk ↗
MHRA approval to add a third cohort using iSCIB1+ to the SCOPE trial
2023-11-28 Scancell Ltd Regulatory Update on SCOPE trial scancell.co.uk ↗
Scancell has also received MHRA correspondence requesting a preclinical mouse safety study with iSCIB1+ prior to resubmission of the a
2023-09-19 Scancell Ltd Regulatory Scancell announces positive data from the first stage in its Phase 2 SCOPE trial with SCIB1 cancer vaccine delivered by needle free injection for advanced melanoma scancell.co.uk ↗

All press releases naming this drug 13 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as iSCIB1+ ClinicalTrials.gov intervention name — accepted as the source's own label NCT07815574 ↗
Modality Vaccine “DNA-based therapeutic cancer vaccine” NCT07815574 ↗
Route Intramuscular “administered by intramuscular injection” NCT07815574 ↗