TIDMSCLP
RNS Number : 4018F
Scancell Holdings Plc
10 July 2023
10 July 2023
Scancell Holdings plc
("Scancell" or the "Company")
Pipeline strategy and business update
-- Strategy to focus on development of Company's two lead clinical assets SCIB1 and Modi-1
-- Phase 2 SCOPE trial testing SCIB1 or iSCIB1+ in combination
with checkpoint inhibitors in metastatic melanoma patients is
progressing well with potential pathway for a registration
trial
-- 44% disease control rate (DCR) in ovarian cancer patients in ModiFY monotherapy trial
-- Cash runway to 2H 2024 which covers near-term inflection points and cohort expansions
Scancell Holdings plc (AIM: SCLP), the developer of novel
immunotherapies for the treatment of cancer and infectious disease,
provides an update on its two ongoing Phase 1/2 clinical trials
with lead cancer vaccine assets SCIB1/iSCIB-1+ and Modi-1.
Encouraging data from these open label studies provides validation
for the Company's decision to concentrate its strategic focus and
resources on these two assets.
"I am very encouraged by the data we have seen so far from both
the SCOPE trial with SCIB1 and the ModiFY trial with Modi-1, which
support the decision to sharpen our focus on these two assets" said
Scancell CEO Lindy Durrant. "With SCIB1 we have a clear potential
development pathway involving a registration trial which could move
this product rapidly towards the market. Additionally, I am pleased
to see that Modi-1 is having an effect on disease control in
ovarian cancer in these very heavily pre-treated patients, although
we believe the true value of our vaccine is probably in combination
with checkpoint inhibitors. We remain well positioned and funded to
continue the development of these high-potential assets to the next
near-term value inflection points."
SCIB1/iSCIB1+
The open-label, Phase 2 single arm SCOPE trial is investigating
the safety and tolerability of using SCIB1/iSCIB1+, Scancell's lead
ImmunoBody(R) cancer vaccine, in combination with checkpoint
inhibitors in patients with advanced melanoma. The current trial is
designed to determine whether any clinical effect is unlikely to be
due to checkpoints alone based on the rate of clinical responses in
each cohort, i.e., with either a single or double checkpoint
combination.
The trial is progressing well, with 73% of the required number
of patients receiving SCIB1 in combination with two checkpoint
inhibitors (ipilimumab and nivolumab) recruited to date. Scancell
expects the initial topline data readout from this double
checkpoint arm of the study in Q4 2023.
Following the data readout, Scancell intends to initiate a
similar double checkpoint cohort with iSCIB1+ before the end of the
year. iSCIB1+ has a number of competitive advantages, with
potentially increased potency due to modifications to the product
using Scancell's propriety AvidiMab(R) platform, and an extended
patent life to 2039. iSCIB1+ is able to be used by a broader
patient population because it incorporates more melanoma-specific
epitopes.
If positive, data generated by iSCIB1+ could lead to the
initiation of a potential, rapid clinical development programme in
H2 2024. An adapted registration trial could yield Phase 2 data
within 2 years and would provide the Company with a pathway to a
potential deal. The Phase 3 data could be complete within the
following 3 years.
Modi-1
Modi-1 is the first vaccine based on Scancell's Moditope(R)
platform. Recruitment is progressing well in the ModiFY open-label
Phase 2a dose expansion study investigating the safety,
tolerability and preliminary efficacy of Modi-1 as a monotherapy
and in combination with checkpoint inhibitors in patients with
ovarian, triple negative breast, renal and head and neck
cancers.
The cohort of 16 ovarian cancer patients receiving Modi-1 has
now been fully recruited. All patients had failed on previous
treatments and their disease was actively progressing when they
entered the study. Following treatment with Modi-1 44% of patients
achieved stable disease for at least 8 weeks, with some patients
experiencing a longer duration of disease stability for 4 months or
more. Four patients are still ongoing in this cohort.
Dr David Pinato, Principal Investigator at Imperial College,
commented: "Advanced ovarian cancer is an aggressive cancer which
is hard to treat. A disease control rate of 44% with Modi-1 in
patients who have exhausted most treatment options is very
encouraging".
The number of patients who have experienced long periods of
stable disease following monotherapy with Modi-1 is encouraging in
this difficult to treat cancer and the Company believes that
combination therapy with checkpoint inhibitors, which are not
currently approved for the treatment of ovarian cancer, could
further improve outcomes for this patient group. Evaluation of
Modi-1 plus checkpoint inhibitors in other tumour types in the
ongoing Phase 1/2 study, will provide supporting data for this
proposed combination use.
In the other monotherapy cancer cohorts, a total of eight
patients have received full dose Modi-1
-- One TNBC patient remains on trial with stable disease beyond 8 weeks
-- One head and neck patient achieved a partial response and remains on study at week 37
Additionally, Scancell has recruited a fourth cohort of three
patients receiving full dose Modi-1 in combination with the
checkpoint inhibitor nivolumab. Subject to a safety committee
review meeting scheduled to take place in August, this cohort will
be expanded to 21 patients in both head and neck and renal cancer.
Preliminary topline data from these cohorts is expected to be
reported in 2024.
Antibody platform
Scancell has developed a novel technology platform for producing
monoclonal antibodies that recognise glycans with high specificity
and affinity. The platform has generated revenues and the
antibodies continue to yield compelling results which have led to a
new 6-month evaluation by a leading Biotech company. Additional
in-house data has illustrated the potential of our antibodies as
chimeric antigen receptor T cell (CART) therapies providing the
data for a deal with a cell therapy company. These results along
with updates on SCIB1 and Modi-1 will be presented at the AACR-CIMT
meeting in Milan in September 2023.
Due to the company increasing focus on its two clinical assets,
Scancell is fully funded to 2H 2024 including the near-term data
inflection points and near-term cohort expansions outlined
above.
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)
Consilium Strategic Communications Tel.: +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.
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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Scancell (AQSE:SCLP.GB)
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Scancell (AQSE:SCLP.GB)
過去 株価チャート
から 1 2024 まで 1 2025
