REG - Scancell Hlds - Positive data from Phase 2 SCOPE trial with SCIB1

Scancell HoldingsAnnouncement

19/09/2023 07:00

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RNS Number : 8466M  Scancell Holdings Plc  19 September 2023

19 September 2023

 

Scancell Holdings plc

("Scancell" or the "Company")

 

 

Scancell announces positive data from the first stage in its Phase 2 SCOPE
trial with SCIB1 cancer vaccine delivered by needle free injection for
advanced melanoma

 

Key Highlights

 

·      SCOPE trial surpasses its first milestone with an 82% response
rate

 

·      To our knowledge no other combination  has achieved this
response rate with doublet checkpoint inhibitors in unresectable metastatic
melanoma

 

·      Analyst and Investor webcast today at 1pm, full details below

 

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for
the treatment of cancer and infectious disease, announces positive data from
the first stage in its Phase 2 SCOPE trial, investigating SCIB1 in combination
with checkpoint inhibitors (CPIs) in advanced melanoma. Initial data from 11
patients showed an 82% objective response rate (ORR) to treatment, which is
better than 70% ORR that the trial was configured to show.

 

The Phase 2 SCOPE trial was designed to determine if the ORR in patients with
unresectable metastatic melanoma could be improved in combination with CPIs.
The concept is that the vaccine induces new, or boosts existing, immune
responses which are subsequently protected in the tumour environment by the
CPIs. During the first stage of the SCOPE trial patients received SCIB1 via a
needle-free device in combination with the most efficacious treatment
currently available, namely the CPIs nivolumab and ipilimumab. The first
milestone in the SCOPE trial was to achieve responses in more than 8 out of 15
patients which would suggest that SCIB1 in combination with doublet CPI
therapy might meaningfully improve current outcomes for these patients. 16
stage IV metastatic patients have received this combination. To date, 11 of
these study patients have reached 13 weeks and been evaluated at radiological
imaging and nine have already shown an objective response, equating to an ORR
of 82% with no increase in toxicity. At this time point the reduction in
tumour volume was 31%-94%. Four patients reaching the 25 weeks imaging
evaluation and two reaching the 37 weeks evaluation have shown a 69%-94% and a
87%-94% reduction in total tumour burden, respectively.  This compares to an
ORR of 50% reported in patients just receiving this doublet CPI therapy in the
real world setting with a progression free survival time of 11.5 months.

 

Prof Poulam Patel, Chief Investigator, added: "These results, if confirmed in
a larger cohort, will be a significant improvement on what patients can expect
from available treatment today. We look forward to continuing the second stage
of the study and reporting further data in due course."

 

Prof Lindy Durrant, Chief Executive Officer of Scancell, commented: "We are
excited by these highly impressive results for SCIB1 combined with the doublet
CPI therapy. We thought results from the Phase 1/2 trial evaluating SCIB1 as a
monotherapy were positive but results from this combination are even more
meaningful. Previous studies indicated that a response rate of 50% was the
best that could be achieved in the real world setting for patients with
unresectable metastatic melanoma, as no other combination had improved on the
response rates for doublet CPI alone. Confirmation of this data in a larger
cohort could make a significant impact on melanoma patient survival,
especially as melanoma is now one of the most common cancers in young women."

 

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 expected to be complete by
the end of 2023 with data available in H1 2024. Based upon the first 11
patients there is a greater than 90% probability that the second phase will
also be successful.

 

An amendment to the current trial protocol, to include a new parallel cohort
with the double CPIs with iSCIB1+, has been submitted to the Medicines and
Healthcare products Regulatory Agency (MHRA). iSCIB1+ has a number of
additional competitive advantages to SCIB1, including potentially increased
potency due to modifications to the product using Scancell's propriety
AvidiMab(®) platform, and an extended patent life. iSCIB1+ is also able to be
used by a broader patient population because it incorporates more
melanoma-specific epitopes. It is anticipated that data from this cohort will
read out in the first half of 2024.

 

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.

 

In addition to SCIB1, Scancell expects significant results from its other
programmes in 2024 including top-line Modi-1 CPI combination data and
attractive out-licensing opportunities from the GlyMab® and AvidiMab®
platforms.

 

Analyst and investor webcast

Professor Lindy Durrant, Chief Executive Officer, and Sath Nirmalananthan,
Chief Financial Officer, will host a live webcast and Q&A session for
analysts and investors at 13:00 BST / 8:00 ET. If you would like to join the
webcast, please follow this link:

 

Issuer Services | London Stock Exchange | SCANCELL HOLDINGS PLC
(lsegissuerservices.com)
(https://www.lsegissuerservices.com/spark/ScancellHoldings/events/ab1023d6-85fa-4125-be9f-527b5166fd7d)

 

 A replay of the webcast will be made available shortly afterwards.

 

Please contact ICR Consilium for further details.

 

 

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

 

 

 For further information, please contact:

 Scancell Holdings plc                                                        +44 (0) 20 3727 1000
 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/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 the SCOPE Phase 2 clinical trial

 

SCOPE is an open label, multicohort, multicentre, Phase 2 study of SCIB1 in
patients with advanced unresectable melanoma receiving either nivolumab with
ipilimumab or pembrolizumab. SCIB1 is a deoxyribonucleic acid (DNA) plasmid
vaccine encoding two CD8 epitopes from the melanoma antigens
tyrosinase-related protein-2 and glycoprotein 100 (gp100), plus two CD4
epitopes from gp100.

 

The purpose of the study is to determine whether the addition of SCIB1 to
standard of care checkpoint inhibitors can improve the objective response rate
(ORR) of patients with advanced melanoma relative to the checkpoint inhibitors
alone. The ORR is defined as the proportion of patients with a complete or
partial response at any time after the start of treatment.

 

During the first stage of the SCOPE trial reported here, patients received
SCIB1 in combination with the best treatment currently available, namely the
CPIs nivolumab and ipilimumab. The First Stage milestone was protocolled to
demonstrate at least a 70% ORR with an 80% power ie at least 8/15 patients
responding, assessed by radiological imaging.

Further information relating to the clinical trial can be found on the
Company's website at  https://www.scancell.co.uk and at
https://classic.clinicaltrials.gov/ct2/show/NCT04079166
(https://classic.clinicaltrials.gov/ct2/show/NCT04079166)

 

About the ModiFY Phase 1/2 clinical trial

 

ModiFY is an open-label, multicohort, multicentre, adaptive Phase 1/2 trial of
Modi-1 in patients with unresectable head and neck, ovarian, triple negative
breast and renal cancer. The Modi-1 peptides are linked to AMPLIVANT®, a
potent adjuvant which is the subject of a worldwide licensing and
collaboration agreement with ISA Pharmaceuticals for the manufacturing,
development, and commercialisation of Modi-1. Modi-1 stimulates CD4 T cells
which may directly impact tumour growth; however, in some patients these T
cells may need to be protected by checkpoint inhibitors if the tumour
environment is highly immunosuppressive. Patients are therefore treated with
Modi-1 alone or, if eligible for standard of care CPI, with Modi-1 plus a
CPI.

 

Cohort 1 of the study confirmed the safety profile of a low dose of two
citrullinated vimentin peptides. The objective for Cohort 2 of the trial was
to assess the safety of the two citrullinated vimentin peptides plus an
enolase peptide at a higher dose. Based on the safety data from Cohort 2, the
ModiFY trial was expanded at this recommended Phase 2 dose for Modi-1
monotherapy in all four tumour types. In parallel, Cohort 3 recruited patients
to receive low dose Modi-1 plus a CPI to assess safety of the combination
prior to testing the higher dose of Modi-1 in Cohort 4.

 

Further information relating to the clinical trial can be found on the
Company's website at https://www.scancell.co.uk (https://www.scancell.co.uk)
and at https://clinicaltrials.gov/ct2/show/NCT05329532
(https://clinicaltrials.gov/ct2/show/NCT05329532)

 

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/)

 

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