TIDMSCLP
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(R)
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(R) and AvidiMab(R) 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)
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
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
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(R), 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 and at
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(R) and
ImmunoBody(R) for vaccines and GlyMab(R) and AvidiMab(R) 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(R) and
ImmunoBody(R)) this includes citrullination and homocitrullination
of proteins, whereas its mAb portfolio targets glycans or sugars
that are added onto proteins and / or lipids (GlyMab(R)) or
enhances the potency of antibodies and their ability to directly
kill tumour cells (AvidiMab(R)).
For further information about Scancell, please visit:
https://www.scancell.co.uk/
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