Scancell announces FDA clearance of IND application for global Phase 3 trial of iSCIB1+ in advanced melanoma
MWN-AI** Summary
Scancell Holdings plc has achieved a significant milestone with the FDA's clearance of its Investigational New Drug (IND) application for a Phase 3 trial of the iSCIB1+ Immunobody® in patients with advanced melanoma. This clearance paves the way for a registry-focused Phase 3 trial expected to begin in 2026, with progression-free survival (PFS) identified as the primary surrogate endpoint.
The decision follows promising outcomes from the Phase 2 SCOPE study, which involved 140 patients and revealed iSCIB1+'s potential to redefine the standard of care in melanoma treatment. Notably, the trial data shows a remarkable 24% improvement in PFS compared to historical benchmarks, indicating a PFS of 74% at 16 months among patients receiving iSCIB1+, significantly outperforming the current standard of care combination of ipilimumab and nivolumab, which reported a PFS of 50% at 11.5 months.
Dr. Phil L'Huillier, CEO of Scancell, expressed confidence in the IND clearance, viewing it as a testament to the clinical benefits and safety profiles of their innovative product. The analysis from the SCOPE trial also allowed for the identification of specific human leukocyte antigen (HLA) alleles, which will be utilized to enrich the patient population for the Phase 3 trial. The positive PFS results were consistent across various subgroups, further enhancing the therapeutic potential of iSCIB1+.
As Scancell prepares for this pivotal Phase 3 trial, it is exploring financing options and partnerships to support its advancement. This development marks a significant leap forward for Scancell in its mission to develop effective immunotherapies for cancer with the broader goal of achieving sustainable tumor-specific immunity.
MWN-AI** Analysis
Scancell Holdings plc (LSE: SCLP) has recently made a significant stride by securing FDA clearance for its IND application concerning the iSCIB1+ Immunobody® in advanced melanoma. This pivotal moment, marking the transition to a registrational Phase 3 trial anticipated to commence in 2026, highlights the potential of iSCIB1+ as a contender to redefine the current treatment paradigm for melanoma.
The data emerging from the Phase 2 SCOPE trial is particularly compelling. An interim 24% improvement in progression-free survival (PFS) against standard care and historical controls suggests that iSCIB1+ could deliver superior outcomes for patients suffering from late-stage melanoma. Given that the therapeutic landscape operates under increasingly stringent regulatory compliance, this FDA endorsement underscores the drug’s robust clinical profile and safety.
For investors, Scancell presents an intriguing opportunity. The firm is further refining its Phase 3 trial design to include patients with select human leukocyte antigen (HLA) alleles, which cover 80% of melanoma cases. This strategic focus could enhance the treatment's efficacy in key populations, potentially leading to better commercialization trajectories and market adoption upon successful outcomes.
Moreover, Scancell is actively pursuing various financing options, including potential partnerships, to support this pivotal trial. This proactive stance may stabilize its financial position and increase investor confidence as the company prepares to enter a more resource-intensive stage of development.
In summary, Scancell's recent advancements in melanoma therapy represent a promising landscape, both clinically and financially. Investors should closely monitor developments as the Phase 3 trial unfolds while considering the company’s strategic financial maneuvers, which could significantly influence its market performance and therapeutic impact in the oncology sector.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Unlocks path towards registrational Phase 3 trial planned to start in 2026
Data from Phase 2 SCOPE trial show iSCIB1+ has potential to redefine standard of care (SoC)
iSCIB1+ shows an interim 24%-point improvement in progression free survival (PFS) over real world SoC and historic controls
NOTTINGHAM, United Kingdom, Jan. 26, 2026 (GLOBE NEWSWIRE) -- 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.
Scancell has completed the 140-patient SCOPE Phase 2, open-label, multi-centre study evaluating ImmunoBody® immunotherapies (SCIB1 and iSCIB1+) in combination with nivolumab plus ipilimumab in previously untreated unresectable stage IIIB/IV melanoma. In addition to demonstrating potentially best-in-class efficacy and durability, from the data analysis we have identified a selection marker to enrich the phase 3 trial for responders.
Dr Phil L'Huillier, CEO of Scancell, said: "This IND clearance creates a clear pathway for late-stage registrational development of our iSCIB1+ Immunobody®. Data from the Phase 2 SCOPE trial shows a significant improvement in progression free survival as well as emerging overall survival with iSCIB1+ compared to historic benchmarks. I take this endorsement of our program as a strong measure of the clinical benefit and safety of our very novel product as well as the quality of our manufacturing and preclinical work. We are continuing our dialogue with regulators broadly as we continue to evaluate all financing options, including partnering discussions, for the Phase 3 trial."
Results from the SCOPE Phase 2 trial have enabled Scancell to select iSCIB1+, administered needle-free intramuscularly, for further development in patients with selected human leukocyte antigen (HLA) alleles, representing 80% of melanoma patients. This profile is reflected within Cohort 3 of the SCOPE trial.
Updated data in this cohort show PFS was 74% at 16 months in the target population. This compares favourably to PFS reported with ipilimumab plus nivolumab alone, the current standard of care, of 50% at 11.5 months[1]. The favourable PFS remains consistent across key subgroups analysed including PD-L1 low, BRAF Wildtype and prior checkpoint inhibitor exposure, who might be expected to have worse outcomes.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
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 enrolling 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 define the parameters to design a Phase 3 randomised 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 a 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 |
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[1] Ipilimumab and Nivolumab in Checkmate 06
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FAQ**
How does the 24%-point improvement in progression-free survival (PFS) for iSCIBcompare to current treatment options provided by Scancell Holdings Plc Ord SCNLF and what implications could this have for market positioning?
What specific selection markers have been identified in the SCOPE trial to enrich the Phase 3 trial population for potential responders, and how might that influence the development strategy for Scancell Holdings Plc Ord SCNLF?
Can Scancell Holdings Plc Ord SCNLF elaborate on the ongoing dialogue with regulators and potential partnerships or financing options being considered for the upcoming Phase 3 trial?
Given the favorable PFS results across key subgroups, how might Scancell Holdings Plc Ord SCNLF leverage this data to enhance patient recruitment and retention in the registrational Phase 3 trial set to start in 2026?
**MWN-AI FAQ is based on asking OpenAI questions about Scancell Holdings Plc Ord (OTC: SCNLF).
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