REG - Scancell Hlds - Pipeline strategy and business update

Scancell HoldingsAnnouncement

10/07/2023 07:00

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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(®) 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(®) 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(®) 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
(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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