Research Update
MWN-AI** Summary
Scancell Holdings plc (AIM: SCLP) recently presented promising Phase 2 data for its iSCIB1+ Immunobody® at the 2025 SITC Annual Meeting in National Harbor, MD. The ongoing SCOPE trial is investigating this DNA-based immunotherapy combined with checkpoint inhibitors for patients with advanced, unresectable melanoma. The trial's results indicate that iSCIB1+ may set a new standard in treatment efficacy, showing a 78% progression-free survival (PFS) at 11 months among the target population, significantly surpassing the historical benchmark of 46% PFS with the current dual checkpoint therapy of ipilimumab and nivolumab.
Dr. Nermeen Varawalla, Scancell's Chief Medical Officer, highlighted the therapeutic potential of iSCIB1+, noting its ability to enhance immune responses and disease control while maintaining a robust safety profile, suitable for standard care integration. The combined data across several cohorts also revealed a 22-month PFS of 69%, indicating substantial improvement over traditional therapies. iSCIB1+ demonstrated superior overall response rates and disease control rates regardless of whether it was combined with dual or single checkpoint therapies.
As a result of these positive findings, Scancell plans to accelerate the development of iSCIB1+, engaging in regulatory discussions and potential partnerships. Randomized studies paving the way for registration are projected to commence in 2026. The SCOPE trial aims to enroll over 140 patients and will guide the design of a Phase 2b/3 registration trial, potentially expanding the treatment's reach to roughly 80% of late-stage melanoma patients.
With their lead Immunobody® product demonstrating meaningful clinical benefits, Scancell is well positioned in the competitive landscape of cancer immunotherapy.
MWN-AI** Analysis
**Market Analysis: Scancell Holdings plc on iSCIB1+ Phase 2 Data Release**
Scancell Holdings plc (AIM: SCLP) has released promising Phase 2 data from its SCOPE trial, showcasing its iSCIB1+ Immunobody® in combination with checkpoint inhibitors for treating late-stage melanoma. The trial's interim results indicate a striking 78% progression-free survival (PFS) rate at 11 months, significantly surpassing traditional doublet checkpoint therapy, which reported a mere 46% PFS at 12 months. This data positions iSCIB1+ as a potential game-changer in melanoma treatment, potentially setting a new benchmark in efficacy, safety, and durability.
The robust results from over 100 patients bolster Scancell’s reputation as a leading innovator in cancer immunotherapy. With plans to accelerate development, including regulatory discussions and anticipated randomized studies beginning in 2026, investors might see Scancell transitioning from a clinical-stage company to a contender in the oncology market.
Given the significant improvement in PFS and overall response rates and disease control rates, iSCIB1+ is primed for broad adoption, potentially reaching 80% of late-stage melanoma patients. Combined with a favorable safety profile, Scancell’s prospects are further enhanced by its proprietary DNA Immunobody® platform, which could expand its treatment offerings into earlier-stage melanoma and other cancers.
In light of these developments, investors should consider Scancell's stock as an attractive long-term opportunity. The favorable outlook, coupled with ongoing trial advancements and potential strategic partnerships, signals a positive trajectory for future growth. However, market participants should remain vigilant, factoring in the inherent risks associated with clinical trials and regulatory approvals. Continuous monitoring of trial progress and market sentiment will be key for informed investment decisions in Scancell Holdings plc.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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 i n 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
NOTTINGHAM, United Kingdom, Nov. 07, 2025 (GLOBE NEWSWIRE) -- 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 ) 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.
Scancell (LSE:SCLP; 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) David Wilson, Claes Spang | +44 (0) 20 3705 9330 |
| Investor and media relations Mary-Ann Chang | +44 (0) 20 7483 284853 MaryAnnChang@scancell.co.uk |
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com .
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1 Ipilimumab and Nivolumab in Checkmate 067
FAQ**
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Given the impressive progression-free survival rates reported in the SCOPE trial, what are the projected market implications for Scancell Holdings plc's stock and its position within the oncology sector compared to treatments like "Scancell Holdings Plc Ord SCNLF"?
Can Scancell Holdings plc provide insights into the anticipated timeline for the commencement of randomized studies on iSCIB1+, and how will this timeline influence the company's growth outlook and stock performance related to "Scancell Holdings Plc Ord SCNLF"?
**MWN-AI FAQ is based on asking OpenAI questions about Scancell Holdings Plc Ord (OTC: SCNLF).
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