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RNS Number : 5721G  Scancell Holdings Plc  07 November 2025

7 November 2025

 

Scancell Holdings plc

 

Scancell holds oral presentation of positive Phase 2 data on Immunobody®
iSCIB1+ in late-stage melanoma at SITC 2025

Data from SCOPE trial show a potential new benchmark in efficacy, durability,
immune responses and safety

Progression-free survival (PFS) for iSCIB1+ in target population at 11 months
is 78%, compared with historic 12 months PFS of 46% with doublet checkpoint
therapy of ipilimumab and nivolumab

Development plans for iSCIB1+ accelerated including regulatory and partnering
discussions, with randomised studies on path to registration expected to start
in 2026

Scancell Holdings plc (AIM: SCLP), the developer of Immunobody® and
Moditope® active immunotherapies to treat cancer, announces the presentation
of positive data from the ongoing Phase 2 SCOPE trial of its iSCIB1+
Immunobody® DNA active immunotherapy, in combination with checkpoint
inhibitors in patients with advanced unresectable melanoma, at the Society for
Immunotherapy of Cancer (SITC) 40(th) Anniversary Annual Meeting in National
Harbor, MD, USA.

The data, first reported in July and now outlined in an oral presentation,
show that iSCIB1+ is a potential new benchmark for treatment of patients with
late-stage melanoma in terms of efficacy, durability, immune responses and
safety. SCOPE results to date show progression-free survival (PFS) for iSCIB1+
in the target human leukocyte antigen (HLA) population at 11 months is 78%,
compared with the historic 12-month PFS of 46% reported by doublet checkpoint
therapy of ipilimumab and nivolumab. 1 

Dr Nermeen Varawalla, Chief Medical Officer of Scancell, said: "The data from
SCOPE so far indicate that iSCIB1+ has groundbreaking potential to deliver
meaningful clinical benefits to patients. It has been shown to enhance
response rates, disease control, progression-free survival and immune
activation, combined with a robust safety profile that allows integration with
standard of care without added toxicity. This positions iSCIB1+ as a
transformative option for patients with metastatic melanoma and opens
possibilities for earlier-stage, resectable disease in neoadjuvant or adjuvant
settings, and we are looking forward to moving this exciting ImmunoBody® into
randomised studies, on the path to registration, in 2026."

Combined data for the defined HLA target population across Cohorts 1 and 3
shows 22-month PFS of 69%, representing a meaningful improvement over historic
doublet checkpoint therapy. The overall response rate (ORR) and disease
control rate (DCR) for SCIB1 and iSCIB1+ also demonstrate superiority whether
combined with doublet checkpoint or single checkpoint therapy, and data from
more than 100 patients across the trial show a favourable safety profile.

Based on these data, iSCIB1+ has been selected for future development
expanding the addressable patients to around 80% of late-stage melanoma
patients and with longer patent life. Development plans are now accelerated
including regulatory and partnering discussions. Randomised studies on the
path to registration are anticipated to begin in 2026.

 

Details of the presentation

Title: SCOPE, an open label phase 2 parallel multi cohort clinical trial
evaluating an off-the-shelf DNA plasmid vaccine in first line advanced
melanoma combined with check point blockade - interim read-out.

Abstract Number: 1325

Session: Clinical Oral Abstract Session 2

Date and time: Saturday, November 8, 2025, 1:45 PM ET

 

 

SCOPE (ClinicalTrials.gov: NCT04079166
(https://clinicaltrials.gov/study/NCT04079166?cond=Melanoma%20Metastatic&term=SCOPE&rank=1)
) is a Phase 2, UK multi-centre open-label study investigating SCIB1/iSCIB1+
in combination with checkpoint inhibitors in late-stage melanoma and will
enrol more than 140 patients across four cohorts. Its aim is to evaluate the
efficacy, safety and durability of SCIB1 or iSCIB1+ DNA Immunobody® therapies
when given to patients in combination with SoC checkpoint inhibitors in stage
IIIB/IV unresectable metastatic melanoma, and to inform the design of a Phase
2b/3 randomised controlled registration trial.

-ENDS-

Scancell (LSE:SCLP; www.scancell.co.uk (http://www.scancell.co.uk) ) is a
clinical stage biotechnology company developing targeted off-the-shelf active
immunotherapies, to generate safe and long-lasting tumour-specific immunity
for a cancer-free future. iSCIB1+, the lead product from their DNA
ImmunoBody® platform has demonstrated safe, durable and clinically meaningful
benefit as a monotherapy as well as additional benefit when combined with
checkpoint therapies in an ongoing Phase 2 trial in melanoma. Modi-1, the lead
peptide immunotherapy from their Moditope® platform, is being investigated in
a Phase 2 study in a broad range of solid tumours. In addition, Scancell's
wholly owned subsidiary, GlyMab Therapeutics Ltd., has been established with
the intention to hold and develop an exciting early-stage pipeline of high
affinity GlyMab® antibodies targeting tumour specific glycans, two of which
already have been licensed and are being developed by Genmab A/S, an
international biotechnology company and global leader in the antibody
therapeutics space.

For more information please contact:

 Scancell Holdings plc                                   +44 (0) 20 3709 5700
 Phil L'Huillier, CEO
 Sath Nirmalananthan, CFO

 Panmure Liberum (Nominated Adviser and Joint Broker)    +44 (0) 20 7886 2500
 Emma Earl, Will Goode, Mark Rogers (Corporate Finance)

 Rupert Dearden (Corporate Broking)

 WG Partners LLP (Joint Broker)                          +44 (0) 20 3705 9330

 David Wilson, Claes Spang

 Investor and media relations                            +44 (0) 20 7483 284853

 Mary-Ann Chang                                          MaryAnnChang@scancell.co.uk

 

 1  Ipilimumab and Nivolumab in Checkmate 067

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