REG - Scancell Hlds - Update on SCOPE trial

Scancell HoldingsAnnouncement

28/11/2023 07:00

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RNS Number : 8275U  Scancell Holdings Plc  28 November 2023

 

27 November 2023

 

Scancell Holdings plc

("Scancell" or the "Company")

 

Update on SCOPE trial

 

-     11 out of 13 patients have responded increasing the ORR to 85%

-     One patient has achieved complete response following treatment

 

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for
the treatment of cancer and infectious disease, announces today it has two
further responders on the SCOPE study, bringing the number of responders to 11
out of 13 patients. This is an objective response rate (ORR) of 85%. These
responses have been verified in nine patients with a second scan at 19 weeks.
Significantly, one of the patients has achieved a complete response following
treatment. The two recent responders are scheduled to have their response
confirmed in a subsequent scan.

 

The SCOPE trial has now successfully transitioned into the second
stage, which will recruit a further 27 patients (for a total of 43). The
aim is to achieve at least 18 further responses (i.e., 27 responses in total)
which would statistically demonstrate that SCIB1, in combination with doublet
therapy, exceeds currently achievable ORRs. Recruitment is on track with data
available in H1 2024. Based upon the first 13 patients there is a greater than
90% probability that the second phase will also be successful.

 

If validated in the second stage of the SCOPE trial this will provide
confidence to initiate 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 should take 18
months and will likely generate significant partner interest.

 

Scancell has also received MHRA correspondence requesting a preclinical mouse
safety study with iSCIB1+ prior to resubmission of the amendment to the
current trial protocol to include a new parallel cohort with the double CPIs
with iSCIB1+. Management do not see any potential issue with this regulatory
request having previously completed identical studies with SCIB1. The iSCIB1+
cohort is now expected to start in Q1 2024.

 

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "The SCOPE
study continues to yield excellent results with two more responders and one of
the previous patients now achieving a complete response. Following routine
communication from the MHRA we now anticipate the iSCIB1+ cohort to commence
in Q1 2024. 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)

 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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