REG - Scancell Hlds - Update on SCOPE trial

Scancell HoldingsAnnouncement

17/01/2024 14:00

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RNS Number : 0436A  Scancell Holdings Plc  17 January 2024

 

17 January 2024

 

This announcement contains inside information for the purposes of Article 7 of
the UK version of Regulation (EU) No 596/2014 which is part of UK law by
virtue of the European Union (Withdrawal) Act 2018, as amended ("MAR"). Upon
the publication of this announcement via a Regulatory Information Service,
this inside information is now considered to be in the public domain.

 

Scancell Holdings plc

("Scancell" or the "Company")

 

Update on SCOPE trial

 

MHRA approval to add a third cohort using iSCIB1+ to the SCOPE trial

 

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for
the treatment of cancer and infectious disease, announces today that following
further discussions with the Medicines and Healthcare products Regulatory
Agency (MHRA), it has now received approval to add a third cohort to the SCOPE
trial. This cohort will recruit 43 advanced unresectable melanoma patients who
will receive iSCIB1+ with doublet therapy, consisting of ipilimumab (Yervoy®)
plus nivolumab (Opdivo®).

 

iSCIB1+ is a modified version of SCIB1 developed using Scancell's AvidiMab®
platform to enhance its potency compared to SCIB1 and gives 15 years of
extended patent protection. 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 HLA dependent.

 

Exceptional results from the first 13 patients receiving SCIB1 in the ongoing
SCOPE trial, with an objective response rate of 85%, indicate a high
probability of success in this cohort which should complete in Q2 2024.
Recruitment into the iSCIB1+ cohort is expected to be complete by the end of
Q2 2024, with early data expected in Q3 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 adapted registration programme
in patients with unresectable melanoma, which represents a potential $1.5
billion per annum market. The Phase 2 part of the adapted trial is anticipated
to take 18 months, with the potential to generate attractive licensing
opportunities.

 

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "Thanks to
the excellent work done by the Scancell team, working hand in hand with a
responsive MHRA, we are pleased to report today that we have received approval
to include a third cohort of patients in the SCOPE trial who will now receive
iSCIB1+ in combination with doublet checkpoints. We anticipate that iSCIB1+
will be as effective as SCIB1 and, with its potentially increased potency and
broader patient profile, make it a promising candidate for registration
studies.  We look forward to providing further updates on our progress given
the extremely positive results to date."

 

-ENDS-

 

 For further information, please contact:

 Scancell Holdings plc                                                        +44 (0) 20 3709 5700
 Professor Lindy Durrant, CEO

 Dr Jean-Michel Cosséry, Non-Executive Chairman

 Stifel Nicolaus Europe Limited (Nominated Adviser and Joint Broker)          +44 (0) 20 7710 7600
 Nicholas Moore/Samira Essebiyea/William Palmer-Brown (Healthcare Investment
 Banking)
 Nick Adams/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/Matthew Neal/Chris Welsh  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 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/ (https://www.scancell.co.uk/)

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014 (MAR).

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