Scancell Holdings Plc · LSE:SCLP
Scancell — ESMO Immuno-Oncology Congress 2025
25 slides from Scancell's conference presentation, Dec 10, 2025
Slide 1: SCOPE, a phase 2 trial with off-the-shelf DNA vaccine in first line advanced melanoma
SCOPE, a phase 2 trial with off-the-shelf DNA vaccine in first line advanced melanoma in combination with check point inhibition Data Update: Safety and Efficacy Dr Heather Shaw Department of Medical Oncology, Mount Vernon Cancer Centre and University College London Hospital 10 December 2025
Slide 2: Declaration of Interests
Declaration of Interests Consulting –Novartis, BMS, MSD, Immunocore, Idera, Iovance, Genmab, Sanofi Genzyme, Regeneron, Macrogenics, Roche, Agenus, Ideaya, iOnctura, CDR-Life, NovalGen, Therakos/Mallinkrodt Pharmaceuticals, Scancell Ltd Speakers bureau –Novartis, BMS, MSD, Sanofi Genzyme, Regeneron,
Slide 3: Immunobody dual mode of action to maximise anti-tumour immune response
Immunobody dual mode of action to maximise anti-tumour immune response following needle free injection • By Direct Presentation ImmunoBody targets antigen presenting cells (APCs) via CD64 resulting in engineered antibodies • By Cross Presentation secretion of engineered antibodies that via Fc domain
Slide 4: SCIB1 & iSCIB1+ are off-the-shelf DNA plasmid cancer vaccines with CD8 & CD4 epitopes
SCIB1 & iSCIB1+ are off-the-shelf DNA plasmid cancer vaccines with CD8 & CD4 epitopes from TRP-2 and gp100 . • SCIB1 and iSCIB1 + incorporate CD8 and CD4 epitopes from TRP-2 and gp100 into an antibody framework to allow direct and Fc targeting of activated dendritic cells • TRP-2 and gp 100 epitopes
Slide 5: SCOPE Program - advanced melanoma with checkpoint inhibitors
SCOPE Program - advanced melanoma with checkpoint inhibitors Phase 2 open label multi cohort translational study enrolling over 140 patients at 16 clinical trial sites in the UK initiated in 2022. STUDY POPULATION STUDY SCHEDULE Advanced melanoma in week combination with standard of 0 1 3 4 7 10 13
Slide 6: Patient Characteristics of Combined SCIB1 & iSCIB1+ HLA eligible population
Patient Characteristics of Combined SCIB1 & iSCIB1+ HLA eligible population Characteristic SCOPE HLA eligible Number of patients 80 Age in years Mean 58 Range 25 - 81 Sex: female % 46.3 ECOG Performance Status in % 0-1 98.8 not reported 1.25 Stage at treatment start in % M0 2.5 M1a, M1b 61.2 M1c 36.
Slide 7: SCOPE: Data Update 27.10.25 data cut
SCOPE: Data Update 27.10.25 data cut Cohort No of Mean follow-up PFS DCR ORR patients SCIB1 HLA 41 13 mths 55% @ 26 mths 83% (34/41) 63% (26/41) Restricted iSCIB1+ Broad HLA 39 8 mths 74% @16 mths 79% (31/39) 56% (22/39) Combined 80 10.5 mths 60% @ 26 mths 81% (65/80) 60% (48/80) HLA Ineligible 13 N
Slide 8: Long term tumour control reflected in durability
Long term tumour control reflected in durability (Target HLA Population (SCIB & iSCIB1+ with SoC ipilimumab/nivolumab (n= 80)) SCIB1: Target Population (HLA-A2) (n=41) ▪ iSCIB1+: Target Population (HLA-A2, A3, A31, B35,Bw4, A33, B44 (n=39) 8
Slide 9: PFS: Target HLA Population iSCIB1+ (n=39)
PFS: Target HLA Population iSCIB1+ (n=39). PFS at 16 months = 74% PFS at 16 months = 74% • 29 Patients Censored (i.e. Ongoing) • 10 Patients with a RECSIT 1.1 PD or Death PFS: 46% at 12 months for SoC nivolumab & ipilimumab 9
Slide 10: PFS Combined SCIB1 & iSCIB1+ in HLA eligible patients (n=80)
PFS Combined SCIB1 & iSCIB1+ in HLA eligible patients (n=80) PFS at 26 months = 60% • 53 Patients Censored PFS: 48% at 24 months for SoC nivolumab & ipilimumab • 27 Patients with RECIST 1.1 PD or Death 10
Slide 11: Overall Survival SCIB1 in HLA-A2 (n=41) with 26 months follow up
Overall Survival SCIB1 in HLA – A2 (n=41) with 26 months follow up OS at 26 months = 77% • 13 Patients Censored • 8 Patients Died OS: 63% at 24 months for SoC nivolumab & ipilimumab 11
Slide 12: PFS: SCIB1 (41) vs iSCIB1+ (39)
PFS: SCIB1 (41) vs iSCIB1+ (39) Circa 12% PFS improvement from next gen iSCIB1+ iSCIB1+ SCIB1 12
Slide 13: Combined SCIB1 & iSCIB1+ in HLA eligible patients (n=80)
Combined SCIB1 & iSCIB1+ in HLA eligible patients (n=80) PD SD PR CR RESPONSES RECIST 1.1 Best Overall Response: Waterfall Plot ORR: 60% (48/80) 15 17 36 12 DCR: 81% (65/80) 13
Slide 14: SCIB1 and iSCIB1+ tolerability
SCIB1 and iSCIB1+ tolerability The administration of SCIB1 and iSCIB1⁺ in combination with ipilimumab and nivolumab was generally safe and well tolerated in a dose range from 0.4 - 8mg. Overall incidence and profile of AEs consistent with those reported for ipilimumab and nivolumab combination thera
Slide 15: Interim Safety Summary – SCIB1 and iSCIB1+ (n = 133)
Interim Safety Summary – SCIB1 and iSCIB1+ (n = 133) Related to SCIB1 or iSCIB1+ Related to checkpoint inhibitors TEAE 305 in 75 (55%) patients 940 in 120 (90%) patients (Total 2156 in 130 (98%) Majority comprised of elevated ALT/AST, injection site bruising, fatigue, Majority comprised of elevated
Slide 16: Conclusions
Conclusions Efficacy benefit, durability & tolerability of iSCIB1+ confirmed with Progression Free Survival improvement is a critically important signal HLA matched population with MHC – class 1 A2, A3, A31, Bw4, B44, B35 comprising 80% of the patient population identified Stable (at -20C) off-the-s
Slide 17: Poster Presentation: T-cell response data with clinical correlation
Poster Presentation: T-cell response data with clinical correlation A DNA plasmid melanoma cancer vaccine, SCIB1 and iSCIB1+ combined with nivolumab and ipilimumab in advanced unresectable melanoma induces potent clinically meaningful CD8 T cell responses in 80% of the patient population. Kate Young
Slide 18: Acknowledgements and Appreciation
Acknowledgements and Appreciation Patients, their Families and Carers Investigators and Clinical Trial Sites Scancell Team Nermeen Varawalla Heather Shaw – Mount Vernon Cancer Centre/University College London Hospital Joe Thornton Pippa Corrie - Addenbrooke's Hospital, Cambridge Georgia Goodhew Sara
Slide 19: European Society for Medical Oncology (ESMO)
European Society for Medical Oncology (ESMO) Via Ginevra 4, CH-6900 Lugano T. +41 (0)91 973 19 00 esmo@esmo.org esmo.org
Slide 20: Extra slides
Extra slides European Society for Medical Oncology (ESMO) Via Ginevra 4, CH-6900 Lugano T. +41 (0)91 973 19 00 esmo@esmo.org esmo.org
Slide 21: Patients with no previous CPI exposure fare better
Patients with no previous CPI exposure fare better Prior exposure N = 18, No prior exposure N = 62 OCTOBER 24 CONFIDENTIAL 21
Slide 22: Combined SCIB1 & iSCIB1+ in HLA eligible patients with no prior CPI exposure (n=62)
Combined SCIB1 & iSCIB1+ in HLA eligible patients with no prior CPI exposure (n=62) PD SD PR CR RESPONSES RECIST 1.1 Best Overall Response: Waterfall Plot ORR: 59.68% (37/62) 11* 13 29 8 DCR: 80.65% (50/62)
Slide 23: Overview of Categories of TEAEs (N=123)
Overview of Categories of TEAEs (N=123) No of Events (n) No. of patients Total Related to Related to Related to Related to (%) IMP / Nivo Ipi/Nivo needle free vaccine procedure All AEs 129 (97) 2148 305 167 750 154 SAEs 80 (60.2) 152 12 13 97 0 AEs ≥ Grade 3 90 (67.7) 197 32 12 125 3 AEs leading to
Slide 24: Summary of Most Frequently Reported TEAEs Related to iSCIB1+ or SCIB1
Summary of Most Frequently Reported TEAEs Considered Related to iSCIB1+ or SCIB1 (in >5% participants Treated with Either IMP) Preferred Term iSCIB1+, n (%) patients [events]N=80 SCIB1, n (%) patients [events] N=53 All Grade ≥3 All Grade ≥3 Injection site bruising 9 (11.3) [16] 0 6 (11.3) [11] 0 ALT
Slide 25: SCIB1-002: Serious Adverse Events in >1 Participant Overall, by SOC and PT
SCIB1-002: Serious Adverse Events in >1 Participant Overall, by SOC and PT (n =133) Primary System Organ Class Preferred Term n (%) patients [events] Endocrine disorders Hypophysitis 5 (3.8) [5] Gastrointestinal disorders Colitis 12 (9.0) [13] Diarrhea 12 (9.0) [17] Enterocolitis 2 (1.5) [2] Immune-
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