REG - Scancell Holdings - Strong Phase 2 data on iSCIB1+ in Melanoma

Scancell HoldingsAnnouncement

Tue 07:00

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RNS Number : 9482R  Scancell Holdings Plc  22 July 2025

22 July 2025

 

Scancell Holdings plc

 

Scancell reports Phase 2 data showing strongly improved outcomes in Late-Stage
Melanoma with its Immunobody® iSCIB1+

SCOPE trial of SCIB1/iSCIB1+ plus standard of care shows excellent results
encompassing efficacy, durability, immune responses and safety

Overall response rate for iSCIB1+ was 69% for target HLA type patients,
representing 80% of total patients - greatly exceeding the 48-50% for standard
of care

12-month progression-free survival also markedly improved, with a 20% increase
over standard of care

iSCIB1+ Immunobody® selected for future development; planning for
registrational Phase 2b/3 global study accelerated

Data provides option for patient selection biomarker for future registrational
study

Scancell to host presentation and Q&A on data at 13:00 BST

 

Scancell Holdings plc (AIM: SCLP), the developer of Immunobody® and
Moditope® active immunotherapies to treat cancer, announces further positive
data from the ongoing Phase 2 SCOPE trial of SCIB1/iSCIB1+ Immunobody® DNA
active immunotherapies in combination with checkpoint inhibitors in patients
with advanced unresectable melanoma. The data demonstrates a potential new
benchmark for treatment of patients with late-stage melanoma in terms of
efficacy, durability, immune responses and safety.

Dr Heather Shaw, lead for the Medical Oncology Skin Cancer Service at
University College London Hospital, London and principal investigator of the
SCOPE trial, said: "The addition of SCIB1 or iSCIB1+ to standard-of-care
checkpoint inhibitors has demonstrated extremely exciting early signals,
including improved overall response rates and progression-free survival to
date, without a meaningful increase in treatment-related toxicity. These
findings highlight the real potential for a significant clinical benefit for
patients with advanced melanoma, where there is an unmet need. As the
progression-free survival and overall survival data matures, expediting the
planned registrational randomised controlled trial will be critical. This
study will have the potential to redefine current treatment paradigms for a
disease that remains challenging for many patients."

Patients in Cohorts 1 and 3 received SCIB1 or iSCIB1+, respectively, in
combination with ipilimumab and nivolumab, the current standard of care
("SoC"). The combined overall response rate ("ORR") for evaluable patients in
Cohorts 1 and 3 was 68.6% (46 out of 67 patients), with a disease control rate
("DCR") of 88.0% and complete response rate ("CR") of 17.9% (12 out of 67
patients). Cohort 2 evaluating SCIB1 in combination with pembrolizumab showed
comparable results in the 9 target patients after the cohort was stopped due
to the change in SoC in the UK. These results represent a substantial
improvement over the previously reported ORR for ipilimumab + nivolumab of 50%
in the Checkmate 067 study and about 48% in the real-world setting*.

Cohort 1 achieved 12-month progression-free survival ("PFS") of 64.6%, and
Cohort 3 demonstrated 11-month PFS of 80.8%. These compare favorably to
previously reported PFS of 43.9% for ipilimumab plus nivolumab at 12 months*.
The safety profiles of the SCIB1/ iSCIB+ combinations with SoC were consistent
with that seen previously with the ipilimumab and nivolumab combination alone,
suggesting the Immunobody® therapy did not add any safety issues and is well
tolerated.

Dr Nermeen Varawalla, Chief Medical Officer of Scancell, said: "iSCIB1+ has
shown meaningful benefits in terms of responses, disease control,
progression-free survival and immune responses, which offer a potentially huge
improvement for patients. Furthermore, its strong safety profile suggests that
iSCIB1+ could be used in addition to SoC without adding toxicities. These data
demonstrate the potential of iSCIB1+ in patients with metastatic melanoma as
well as highlight the significant potential in earlier stage resectable
disease when administered in the neoadjuvant / adjuvant setting. The results
also provide the option of a biomarker to predict responders which could be a
significant advantage in selecting participants in a future registrational
study."

The recent updated data showed that all six epitopes in the DNA Immumobody®
therapy iSCIB1+, generated targeted T cell responses. CD8 T cell responses
were associated with an improved clinical response rate of 83%. These T cells
both kill tumor cells and induce memory T cells, resulting in a deep and
prolonged response. The CD8 T cell response could be predicted using the human
leukocyte antigen ("HLA") class I alleles which in turn could be a patient
selection biomarker. This next-generation Immunobody® iSCIB1+, includes
additional epitopes targeting HLA class 1 alleles present in 80% of the
population, has improved avidity from Scancell's AvidiMab® platform, and
showed equipotency and equal safety compared to SCIB1. iSCIB1+ is efficacious
in a wider patient population than SCIB1, 80% compared with 40% for SCIB1 and
is therefore the candidate of choice for further development. This rapid
development of iSCIB1+ demonstrates the potential of Scancell's technology
platforms for continuous product refinement and improvement so as to provide
greater benefits for larger numbers of patients. The SCOPE study also provides
Scancell with the option of a patient selection biomarker for a future
registrational study.

Dr Phil L'Huillier, CEO of Scancell, said: "These data demonstrate that we can
add iSCIB1+ to the combination of nivolumab and ipilimumab, or potentially
combine it with pembrolizumab, to produce a marked benefit for patients with
advanced melanoma. In the US alone, ipilimumab plus nivolumab has a market
share of 65-70% of metastatic melanoma patients. We have selected iSCIB1+ for
further development and are now accelerating our planning for a global
registrational study in the advanced melanoma setting and assessing the
potential of a second trial in earlier lines of disease. We expect to engage
with the U.S. Food and Drug Administration on the design of this trial ahead
of reporting interim data from Cohort 4, which we expect around the year end."

SCOPE (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
enroll 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 randomized controlled registration trial.

Scancell will host a presentation on the SCOPE data, followed by a Q&A
with management, on 22 July at 13:00 BST. Please click here
(https://sparklive.lseg.com/ScancellHoldings/events/333037ab-7ab7-47b0-b278-416719b77a0a)
to register for the call.

*European Journal of Cancer 2022 (Serra-Bellver et al)

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

-ENDS-

SCIB1 is the lead product from the Company's DNA Immunobody® platform, which
uses the body's immune system to identify, attack and destroy tumors. iSCIB1+
is a modified version of SCIB1 developed using Scancell's AvidiMab® platform
to enhance its potency compared to SCIB1. iSCIB1+ also includes additional
melanoma-specific epitopes so it has the potential to be effective in a broad
patient population.

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 tumor-specific immunity for
a cancer-free future. iSCIB1/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 tumors. In addition, Scancell's
wholly-owned subsidiary, Glymab Therapeutics Ltd., is developing an exciting
early-stage pipeline of high affinity GlyMab® antibodies targeting tumor
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

 

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