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REG - Scancell Hlds - Scancell to present at 2025 AACR Annual Meeting

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RNS Number : 0979D  Scancell Holdings Plc  01 April 2025

1 April 2025

 

Scancell Holdings plc

("Scancell" or the "Company")

 

Scancell to Present Clinical Data from the Ongoing Phase 2 SCOPE Trial of
SCIB1 at 2025 AACR Annual Meeting

 

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapy
products for the treatment of multiple cancers, today announce clinical data
from the ongoing Phase 2 SCOPE trial will be presented at the American
Association for Cancer Research (AACR) Annual Meeting, taking place in
Chicago, Illinois on 25-30 April 2025.

 

SCIB1 is a potent, targeted DNA melanoma cancer vaccine, that effectively
activates high-avidity T cells, leading to a potent, lasting immune response
by creating an immune memory that prevents the cancer from recurring.

 

The SCOPE study (NCT04079166) is a Phase 2, Multicentre Open-Label, Study,
investigating SCIB1/ iSCIB1+, with double checkpoint inhibitors ("CPIs") in
late-stage melanoma. The first cohort includes 43 patients receiving SCIB1 in
combination with ipilimumab and nivolumab. Initial data in 25 patients has
shown

·      84% disease control rate;

·      80% progression free survival, with 20% complete response rate;
and

·      72% objective response rate.

 

Scancell CMO Nermeen Varawalla will present the SCOPE clinical trial program,
preliminary results of cohort 1 and their correlation with T cell responses.
These data along with those expected from ongoing study cohorts, 3 & 4
will determine the design for the planned follow-on randomised registration
clinical trial.

 

The AACR conference is an internationally recognised annual meeting, bringing
together world-leading experts to share the latest advances in oncology.

 

Phil L'Huillier, Chief Executive Officer, Scancell, commented: "We are excited
to share these SCOPE trial results with the scientific community at AACR. The
strong disease control and response rate, with an excellent safety profile
reinforces the potential of our vaccine to transform melanoma treatment. Our
next generation vaccine iSCIB1+ is also being evaluated in a broader patient
population within other cohorts of the study. The findings from the overall
study will inform the design of our planned global randomized control
registration trial."

 

Presentation Details:

 

Title: A DNA plasmid melanoma cancer vaccine, SCIB1, combined with nivolumab +
ipilimumab in patients with advanced unresectable melanoma: Efficacy and
safety results from the open-label Phase 2 SCOPE Trial

Session: LBPO.CL01 - Late-Breaking Research: Clinical Research 1

Session Date and Time: Monday 28 April, 2:00 - 5:00 PM

Location: McCormick Place Convention Center - Section 53

Published Abstract Number: LB214 / 11

Presenter: Nermeen Varawalla

Authors: Heather Shaw, Poulam Patel, Miranda Payne, Satish Kumar, Sarah
Danson, Martin Highley, Clare Barlow, Kellati Prasad, Ioannis Karydis, Maria
Marples, Kate Young, Pippa Corrie, Robert Miller, Georgia Goodhew, Samantha
Paston, Gaelle Cane, Joe Chadwick, Lindy Durrant and Nermeen Varawalla

 

 

 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, Satheesh Nadarajah

 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 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 is a clinical stage biopharmaceutical company that is leveraging its
proprietary research, built up over many years of studying the human adaptive
immune system, to generate novel medicines to treat significant unmet needs in
cancer. The Company is building a pipeline of innovative products by utilising
its four technology platforms: Moditope® and ImmunoBody® for vaccines and
GlyMab® and AvidiMab® for antibodies.  Adaptive immune responses include
antibodies and T cells (CD4 and CD8), both of which can recognise damaged or
infected cells. In order to destroy such cancerous or infected cells, Scancell
uses either vaccines to induce immune responses or monoclonal antibodies
(mAbs) to redirect immune cells or drugs. The Company's unique approach is
that its innovative products target modifications of proteins and lipids. For
the vaccines (Moditope® and ImmunoBody® ) this includes citrullination and
homocitrullination of proteins, whereas its mAb portfolio targets glycans or
sugars that are added onto proteins and / or lipids (GlyMab® ) or enhances
the potency of antibodies and their ability to directly kill tumour cells
(AvidiMab® ).

For further information about Scancell, please visit:
https://www.scancell.co.uk/ (https://www.scancell.co.uk/)

 

 

 

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