30 May 2024
Scancell Holdings
plc
("Scancell" or the "Company")
Scancell receives MHRA approval to
expand ModiFY trial
Modi-1 to be assessed in
renal cell carcinoma in combination with double checkpoint
inhibitors
Scancell Holdings plc (AIM: SCLP),
the developer of novel immunotherapies for the treatment of cancer,
today announces that, following further discussions with the
Medicines and Healthcare products Regulatory Agency (MHRA), it has
received approval to add an expansion cohort to the ModiFY trial.
This cohort will recruit 44 previously untreated renal cell
carcinoma (RCC) patients who will receive Scancell's Modi-1 cancer
vaccine in combination with doublet checkpoint inhibitor (CPI)
therapy, consisting of ipilimumab (Yervoy®) plus nivolumab
(Opdivo®).
Early data from patients receiving
Modi-1 as a monotherapy have demonstrated stable disease, good T
cell responses, safety and tolerability, with the absence of dose
limiting toxicities in dose escalation cohorts. Modi-1 is also
being used to treat head and neck cancer patients who receive
single CPI as standard of care. Treatment of patients with advanced
or metastatic RCC in the first-line setting consists of double CPI
therapy. The addition of Modi-1 to this cohort will enable the
testing of the synergistic effect of Modi-1 peptides in improving
the overall response rate, as demonstrated in our
SCOPE trial, showing that the double checkpoints are ideal in
synergising with targeted vaccines.
Dr
Stefan N Symeonides, Consultant Medical Oncologist & Senior
Lecturer in Experimental Cancer Medicine, University of Edinburgh,
said "The addition of Modi-1 to
ipilimumab with nivolumab in patients with untreated renal cell
carcinoma in the ModiFY basket study will address important
clinical and immunological questions. The outcomes from this cohort
will help with patient selection for the subsequent phases of
clinical development of Modi-1."
Prof Lindy Durrant, Chief Executive Officer, Scancell
said: "We greatly appreciate the
supportive and helpful discussions with the MHRA and are thrilled
to have received approval to expand ModiFY into a cohort of
patients who will now receive Modi-1 in combination with double
checkpoint inhibitors. This approval marks another milestone for
Scancell, and the promising efficacy, safety and tolerability study
generated from earlier cohorts underscore our belief that our
Modi-1 cancer vaccine has the potential to deliver a step change in
the treatment of renal and other hard-to-treat cancers."
The Company expects early clinical
data from patients treated with Modi-1 plus CPIs later this year.
-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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Dr Jean-Michel Cosséry,
Non-Executive Chairman
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Professor Lindy Durrant,
CEO
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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/Ben
Good
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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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ICR
Consilium
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+44 (0) 20 3709 5700
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Mary-Jane Elliott/Angela
Gray/Lindsey Neville
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scancell@consilium-comms.com
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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. 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/
About the ModiFY trial
Modi-1 is the first candidate in
Scancell's Moditope® platform. The ModiFY study is a multicentre
Phase 1/2 open label first-in-human clinical trial with Modi-1, an
innovative cancer vaccine targeting citrullination in cancer, being
administered alone or in combination with CPIs in patients with
head and neck and renal tumours and as a monotherapy in patients
with ovarian cancer, triple negative breast and renal cancer.
Modi-1 stimulates CD4 T cells which may directly impact
tumour growth however in some patients if the tumour environment is
highly immunosuppressive, these T cells may need to be protected by
CPIs. This open label Phase 1/2 study is assessing the safety and
immunogenicity of two citrullinated vimentin peptides and a
citrullinated enolase peptide.