26 March 2024
Scancell Holdings plc
("Scancell" or the
"Company")
Update on SCOPE trial
The first patient has been dosed with
iSCIB1+ in the SCOPE trial
Scancell Holdings plc (AIM: SCLP),
the developer of novel immunotherapies for the treatment of cancer
and infectious disease, announces today that the first patient has
been dosed with iSCIB1+ and doublet
checkpoint inhibitor therapy, consisting of ipilimumab (Yervoy®)
plus nivolumab (Opdivo®), in the SCOPE trial's new
cohort.
Prof Lindy Durrant, Chief Executive Officer, Scancell,
commented: "Following approval earlier
this year from the Medicines and Healthcare products Regulatory
Agency (MHRA) to add a third cohort to the SCOPE trial, we are very
pleased to announce that the first patient has been dosed with
iSCIB1+ with doublet therapy in line with our previous guidance on
timing. As we have previously communicated, we anticipate
that iSCIB1+ will be as effective as SCIB1 and could be a promising
candidate for registration studies. We look forward to progressing
the trial and to providing further updates to the market in due
course."
Dr
L S Prasad Kellati, Consultant Medical Oncologist from the Royal
Preston Hospital, UK commented: "We are very excited to have
dosed our patient in the iSCIB1+ in combination with doublet
checkpoint cohort of the SCOPE trial. With its potentially
increased potency and applicability to a broader patient profile,
we believe iSCIB1+ represents a major step forward in providing
more metastatic melanoma patients the potential benefits of
combining standard of care checkpoint therapy with Scancell' s
innovative cancer vaccines."
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.
As iSCIB1+ is very similar to SCIB1
it is anticipated that it should show the same exceptional results
as SCIB1 with an objective response rate of 85% but in a broader
range of melanoma patients. Recruitment into the iSCIB1+ cohort is
expected to be complete by the end of Q3 2024. Early data from this
cohort is expected in Q4 2024.
The results from these SCIB1 and
iSCIB1+ cohorts, administered in combination with doublet therapy,
will enable the Company to make a data-led decision
regarding initiation of a randomised Phase
2/3 seamless adaptive registration programme in patients with
unresectable melanoma, which represents a potential $1.5 billion
per annum market. The Phase 2 part of the adaptive trial is
anticipated to take 18 months and will likely generate significant
partner interest.
-ENDS-
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For further
information, please contact:
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Scancell
Holdings plc
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+44 (0) 20 3709 5700
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Professor Lindy Durrant, CEO
Dr Jean-Michel Cosséry, Non-Executive
Chairman
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Stifel Nicolaus
Europe Limited (Nominated Adviser and Joint Broker)
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+44 (0) 20 7710 7600
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Nicholas Moore/Samira Essebiyea (Healthcare Investment
Banking)
Nick Adams/Nick Harland (Corporate Broking)
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WG
Partners LLP (Joint Broker)
David Wilson/Claes Spang/Sathesh
Nadarajah/Erland Sternby
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+44 (0) 20 3705 9330
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Panmure Gordon (UK)
Limited (Joint Broker)
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+44 (0) 20 7886 2500
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Freddy Crossley/Emma Earl (Corporate Finance)
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Rupert Dearden (Corporate Broking)
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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 and infectious disease. 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/
This
announcement contains inside information for the purposes of
Article 7 of Regulation (EU) 596/2014 (MAR).