REG - Scancell Hlds - First iSCIB1+ patient dosed

Scancell HoldingsAnnouncement

26/03/2024 12:30

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RNS Number : 3682I  Scancell Holdings Plc  26 March 2024

 

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-

 

 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 (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/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 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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