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RNS Number : 3616Q Scancell Holdings Plc 30 May 2024
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-
For further information, please contact:
Scancell Holdings plc +44 (0) 20 3709 5700
Dr Jean-Michel Cosséry, Non-Executive Chairman
Professor Lindy Durrant, CEO
Stifel Nicolaus Europe Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7710 7600
Nicholas Moore/Samira Essebiyea/Ben Good
Nick Harland (Corporate Broking)
WG Partners LLP (Joint Broker) +44 (0) 20 3705 9330
David Wilson/Claes Spang/Sathesh Nadarajah/Erland Sternby
Panmure Gordon (UK) Limited (Joint Broker) +44 (0) 20 7886 2500
Freddy Crossley/Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
ICR Consilium +44 (0) 20 3709 5700
Mary-Jane Elliott/Angela Gray/Lindsey Neville scancell@consilium-comms.com (mailto:scancell@consilium-comms.com)
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/)
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.
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