REG - Scancell Hlds - Partnership with NHS Cancer Vaccine Launch Pad

Scancell HoldingsAnnouncement

14/04/2025 07:00

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RNS Number : 8597E  Scancell Holdings Plc  14 April 2025

14 April 2025

 

Scancell Holdings plc

("Scancell" or the "Company")

 

Partnership with NHS Cancer Vaccine Launch Pad Enabling

Fast-Tracked Access for Melanoma Patients

 

 

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapy
products for the treatment of multiple cancers, announces a partnership with
the NHS Cancer Vaccine Launch Pad (CVLP) to fast-track access for NHS patients
into the fourth cohort of the Company's Phase 2 clinical SCOPE study. This
cohort will evaluate intradermal administration of Scancell's iSCIB1+, potent,
targeted "off-the-shelf" Immunobody® second generation DNA cancer vaccine, in
patients with advanced unresectable melanoma receiving standard of care
immunotherapy treatments.

 

The CVLP, launched in May 2024, is a world-leading NHS trial "matchmaking"
service to help find new life-saving treatments. NHS Hospitals across the
country will be able to take part in this transformational study, with
eligible patients from around the UK being referred to a participating NHS
site. The partnership is being coordinated and run by the Southampton Clinical
Trials Unit, with the first patients expected to be referred from May.
Scancell is the first British company to join the CVLP, and iSCIB1+ is the
first DNA vaccine to be part of this initiative.

 

Melanoma is the fifth most common cancer in the UK, accounting for around 4%
of all new cancer cases. While immunotherapy is a standard treatment for
advanced melanoma patients, only about half of patients respond well, leaving
the rest at risk of disease progression and metastases. iSCIB1+ precisely
targets activated antigen presenting cells via CD64 and effectively activates
high-avidity T cells, leading to a potent, lasting immune response thereby
creating an immune memory that may prevent the cancer from recurring. As a
part of the trial, patient tissue type or "HLA" type will need to be
determined by using a blood test to look for the presence or absence of genes
which control how the immune system works.

 

Dr Nermeen Varawalla, Chief Medical Officer, Scancell, said: "Cancer vaccines
have the potential to transform immunotherapy, redefine treatment options and
ultimately save lives. Recent clinical data has demonstrated that our potent,
tumour-targeted 'off-the-shelf' cancer vaccine delivers strong efficacy, with
the potential for meaningful long-term survival benefits in patients with
advanced metastatic melanoma. Our partnership with the CVLP will give patients
expedited access to this landmark study and is an important step in
accelerating the clinical development of this important new treatment."

 

NHS national cancer director Professor Peter Johnson said: "Skin cancer can
have a devastating impact, and we know that cancer vaccines have the potential
to revolutionise cancer care for patients in this country and across the world
- and to save more lives. It's incredibly exciting that the NHS is expanding
its world-leading programme so more patients with different types of cancer
could benefit from the development of new vaccines that could stop their
cancer coming back."

 

The SCOPE study will enrol over 140 patients across four cohorts. Reported
phase 2 clinical data from 25 patients in cohort 1 receiving the
first-generation vaccine SCIB1 i.m. in combination with checkpoint inhibitors,
ipilimumab and nivolumab, have shown 80% progression free survival (PFS) and
20% complete response rate (CR). Cohort 3, investigating the next generation
iSCIB1+i.m. in combination with ipilimumab and nivolumab, has now completed
recruitment of 45 patients and the fourth cohort, to be recruited in
partnership with CVLP, will evaluate intradermal administration of iSCIB1+

 

Data from all study cohorts in the SCOPE trial will inform the design of the
upcoming randomised trial, which is planned for in H2 2026, either by Scancell
or in partnership. Clinical data from SCIB1 in cohort 1 and iSCIB1+ in cohort
3 is expected around mid-2025, while clinical data from iSCIB1+ in cohort 4,
following the partnership with CVLP, is expected late 2025.

 

Phil L'Huillier, Chief Executive Officer, Scancell, commented: "We are
delighted to announce our partnership with the CVLP. This partnership offers
melanoma patients in the UK faster access to our developmental cancer vaccine,
iSCIB1+, that we see is bringing long term immune control of the tumours to
these advanced melanoma patients. It additionally underscores the potential
benefit of iSCIB1+ to advanced stage melanoma patients and the longer-term
market opportunity. Data from the SCOPE study will allow us to implement a
robust development plan for the next phase towards registration in 2026."

 

 For further information, please contact:

 Scancell Holdings plc                                   +44 (0) 20 3709 5700
 Phil L'Huillier, CEO
 Sath Nirmalananthan, CFO
 Dr Jean-Michel Cosséry, Non-Executive Chairman

 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

 ICR Healthcare                                          +44 (0) 20 3709 5700

 Mary-Jane Elliott, Stephanie Cuthbert, Chris Welsh      scancell@consilium-comms.com (mailto:scancell@consilium-comms.com)

 

About SCIB1/iSCIB1+

 

SCIB1 is the lead product from the Company's ImmunoBody® DNA Vaccine
platform, which uses the body's immune system to identify, attack and destroy
tumours. 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 broader patient population beyond the 40% of patients with the
tissue type treatable with SCIB1, where treatment is human leukocyte antigen
(HLA) dependent.

 

About the SCOPE Study

 

The SCOPE Study (NCT04079166
(https://clinicaltrials.gov/study/NCT04079166?term=scib1&rank=2) ) is a
Phase 2, Multicentre, Open-Label, Umbrella Study of SCIB1 and iSCIB1+ in
Patients With Advanced Unresectable Melanoma Receiving Nivolumab With
Ipilimumab or SCIB1 With Pembrolizumab to determine the response rate and
safety and tolerability of intramuscular SCIB1 or iSCIB1+ when added to
nivolumab (Opdivo) with ipilimumab (Yervoy) or SCIB1 with pembrolizumab
(Keytruda). Conducted across approximately 15 sites in the United Kingdom,
this multi-site trial aims to demonstrate durable and potent anti-tumour
activity and ORR of SCIB1/iSCIB1+ in addition to standard of care checkpoint
inhibitors. Additional endpoints include disease control rate (DCR), duration
of response (DOR), progression free survival (PFS), overall survival (OS),
safety, and tolerability. Participants receive up to 10 doses of
either SCIB1 or iSCIB1+ using PharmaJet Stratis® needle-free injection
device system in the upper arm or upper leg. up to 85 weeks, in combination
with nivolumab with ipilimumab or SCIB1 with pembrolizumab. More
information on this trial can be found at clinicaltrials.gov
(https://www.globenewswire.com/Tracker?data=kFdkwwLSgbD6z3fn9vUCka0Qz0AJKqFORBMc75T9h3-ujhX_zVQAo_xfzHMq1VSVaSwzYC-I4BJQN091N6PmYaksDhJ1Zxmuq5mzXzNqNFmb1OF68oHsNmON1xEoQHNN)
 or www.clinicaltrialsregister.eu
(https://www.globenewswire.com/Tracker?data=xr5c6tg-TO35E29FgLlaybp84b5tzMcxFBAWSK6wNjjVV9lFuc0E-ved76qXQ6iE3li1AgSKKhIzCZ7ZVeGWf0BwH1imiXxE1qEd6o-HwfgHdY4-D7q9cstA7wq7LA7s)
.

 

About Scancell

 

Scancell (LSE:SCLP) develops immunotherapies for a Cancer-free future by
enhancing long-lasting tumour specific immunity. As a clinical stage
biotechnology company with deep roots in cancer immunology and translational
research, Scancell develops tumour targeted off-the-shelf vaccines, with
highly favourable safety and durable systemic immune responses. Scancell's
lead product, iSCIB1+, a DNA vaccine, is currently showing strong promise on
top of checkpoint therapies in a multi-arm phase 2 study in first-line
melanoma. The second vaccine Modi-1 is being investigated in a phase 2 study
in a broad range of solid tumours. Scancell is also developing a pipeline of
high affinity antibodies targeting tumour specific glycans using its
proprietary platforms. Two of these antibodies are now being developed in
major biopharma partnerships and a further two antibodies targeting lung and
epithelial cancers, are actively being developed in-house.

https://www.scancell.co.uk (https://www.scancell.co.uk)

 

 

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