REG - Scancell Holdings - Continued improvement in PFS with iSCIB1+

Scancell HoldingsAnnouncement

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RNS Number : 7242K  Scancell Holdings Plc  09 December 2025

9 December 2025

 

Scancell Holdings plc

Scancell updated Phase 2 data shows continued improvement in progression free
survival with iSCIB1+ in patients with first line advanced melanoma

Progression free survival (PFS) of 74% at 16 months compares favourably to
standard of care PFS of 50% at 11.5 months (1)

Strong PFS consistent across key subgroups

Reaffirms selection of iSCIB1+ and target HLA population for late-stage
development

Early overall survival (OS) data, most advanced for SCIB1, showing a 14%
improvement at 26 months over SoC(1)

In advanced planning for registrational trials with positive scientific advice
from regulators

To hold late-breaking oral presentation on SCOPE trial at ESMO IO conference

Investor webinar on Thursday 11(th) December 2025 at 2.00pm GMT

Scancell Holdings plc (AIM: SCLP), the developer of active immunotherapies to
treat cancer, announces updated positive data from the SCOPE Phase 2 trial
of iSCIB1+ in combination with ipilimumab and nivolumab, current standard of
care (SoC). A late-breaking abstract on the data has been released, and an
additional poster presentation will be made during an oral session at the ESMO
Immuno-Oncology Congress 2025 (ESMO IO) conference on 11(th) December 2025.

Results from SCOPE to date have enabled Scancell to select Immunobody iSCIB1+,
administered needle-free intramuscularly, for further development in patients
with selected human leukocyte antigen (HLA) alleles ("the target population"),
representing 80% of melanoma patients. This profile is reflected within Cohort
3 of the SCOPE trial.

Updated data in this cohort show progression free survival (PFS) was 74% at 16
months in the target population. This compares favourably to PFS reported with
ipilimumab plus nivolumab alone 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. Cohort 3 comprised a total of 50 patients of which 39
were in the target HLA population, 10 outside the target HLA population and
one was non-evaluable due to active brain metastases. Data in this cohort from
the non-target population support the use of HLA as a biomarker for a
registrational trial, with PFS of 20% at 14 months and overall response rate
of 20%, albeit in a small number of patients.

Dr Heather Shaw, lead for the Medical Oncology Skin Cancer Service at
University College London Hospital, London and principal investigator of the
SCOPE trial at Mount Vernon Cancer Centre, said: "The prolonged progression
free survival demonstrates iSCIB1+ in combination with checkpoint inhibitors
has potential to redefine standard of care. This therapy combination increases
the number of advanced melanoma patients who would benefit and improves the
duration of their clinical response versus equivalent timepoints with
checkpoint inhibition alone, thus representing an important step forward for
patient outcomes."

Overall response rate for the target population in Cohort 3 was 56%, with a
disease control rate of 79%. iSCIB1+ specific T cell responses correlated
positively with clinical benefit, seen in 72% of patients mounting a T-cell
response to both GP100 and TRP2 epitopes, thereby overcoming immune escape. A
memory T-cell response phenotype was also characterised in these patients.
Early overall survival (OS) data, most advanced for SCIB1, shows a 14%
improvement at 26 months over SoC.

Dr Nermeen Varawalla, Chief Medical Officer of Scancell, said: "iSCIB1+, in
combination with checkpoint inhibitors, is showing a significant 24%
improvement in PFS over standard of care and more efficacy than the first
generation SCIB1. This provides additional confidence in the Immunobody®
being taken forward towards registrational trials. The translational data
backing these clinical outcomes is also compelling, showing that iSCIB1+
drives a powerful durable T-cell response."

The Company has held positive discussions with the U.S Food and Drug
Administration (US FDA) and other regulatory agencies. The feedback received
to date supports our plans to move to Phase 3 registrational development with
iSCIB1+ with alignment on trial design, dose, manufacturing and progression
free survival as the expected registrational endpoint. The Company will
continue active partnering, whilst assessing options to finance the next stage
of development.

Dr Phil L'Huillier, CEO of Scancell, said: "These results give further
momentum to our advanced planning for late-stage clinical development. We are
continuing our positive discussions with the US FDA and other regulators, with
feedback supporting our plans to move iSCIB1+ to late-stage development in
2026. The positive and growing durability of responses with iSCIB1+ delivered
intramuscularly demonstrate that this method of administration is the optimal
form to be investigated in late-stage development, and as a result we have
decided not to continue with Cohort 4, with iSCIB1+ delivered intradermally.
In parallel, we are also in active discussions with potential partners as we
assess the optimal options to finance this next stage."

Scancell will host a presentation on the SCOPE data, followed by a Q&A
with management, on 11 December at 14:00 GMT. Please click here
(https://sparklive.lseg.com/ScancellHoldings/events/c3721d93-4edd-4d52-98ca-842f89c79198/scancell-scope-update-with-esmo-io-data-december-2025)
to register for the call.

Details of the ESMO IO oral and poster presentation

Title: SCOPE, phase 2 clinical trial with off-the-shelf DNA plasmid vaccine in
first line advanced melanoma with check point inhibition

Presenter: Professor Heather Shaw, Medical Oncology, Mount Vernon Cancer
Centre, University College London

Time: Thursday December 11, 11:50 GMT

Location: 2025 ESMO Immuno-Oncology Annual Congress, Queen Elizabeth II
Conference Centre, London

 

                                                                       Cohort 1                                                                 Cohort 3                                                                   Cohort 3    Combined Cohorts                                                       CheckMate 067
 Product                                                               SCIB1                                                                    iSCIB1+                                                                    iSCIB1+     SCIB1 & iSCIB1+
 HLA population                                                        Target                                                                   Target                                                                     Non Target  Target                                                                 n/a

                                                                       A2                                                                       A2, A3, A31, Bw4, B35 and B44                                              A1          A2, A3, A31, Bw4, B35 and B44
 N=                                                                    41                                                                       39                                                                         10          80                                                                     314
 Overall Survival (OS)                                                 77%                                                                      Too early                                                                  Too early   Too early                                                              63%

                                                                       26 months                                                                                                                                                                                                                              26 months
 Progression Free Survival                                             55%                              26 months                               74%                               16 months                                20%         60%                             26 months                              50%                              11.5 months
 (PFS)

                                                                                                                                                                                                                           14 months
 DCR                                                                   83%                                                                      79%                                                                        40%         81%                                                                    63%
 ORR                                                                   63%                                                                      56%                                                                        20%         60%                                                                    50% confirmed
 Non-evaluable                                                         2                                                                        1                                                                          -           -                                                                      -

Note: Combined cohorts illustrative of larger target HLA population. Cohort 2
was halted previously due to a change in standard of care. Cohort 4 too early
for meaningful PFS analysis.

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014 (MAR).

-ENDS-

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 define the parameters to
design a Phase 3 randomised registration trial.

iSCIB1+ incorporates specific epitopes from the proteins gp100 and TRP-2 which
play key roles in the production of melanin in the skin and were identified
from T cells of patients who achieved spontaneous recovery from melanoma skin
cancers. iSCIB1+ was designed to work in HLA alleles A1, A2, A3, A31, A33,
Bw4, B35, and B44, representing close to 100% of late-stage melanoma patients.
The Phase 2 study has confirmed iSCIB1+ combination with SoC is efficacious in
patients with A2, A3, A31, Bw4, B35 and B44 epitopes, representing 80% of the
melanoma patients, though the combination did not stimulate a clinical
response in patients with A1 and other HLA types with no matched epitopes. The
selected HLA alleles of A2, A3, A31, Bw4, B35 and B44 are thus defined as the
target HLA population. This HLA selection can be used as a tool to select for
responders in future clinical development.

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.

Progression free survival:  The length of time during and after treatment
that a patient lives with a disease without it worsening.

Overall survival: The length of time from diagnosis or treatment for a
disease, that patients are still alive.

 

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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