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RNS Number : 4947Q
Scancell Holdings Plc
21 February 2023
21 February 2023
Scancell Holdings plc
("Scancell" or the "Company")
Encouraging early efficacy data from monotherapy part of ModiFY
Phase 1/2 clinical trial
Modi-1 cancer vaccine showed partial response and stable disease
in patients with hard-to-treat head and neck, high grade serous
ovarian or triple negative breast cancers
First clinical candidate from Moditope(R) platform well
tolerated with no dose limiting toxicities
Scancell Holdings plc (AIM: SCLP), the developer of novel
immunotherapies for the treatment of cancer and infectious disease,
today announces completion of the monotherapy dose finding arm of
the multicentre Phase 1/2 ModiFY clinical trial. Data from patients
receiving the Modi-1 cancer vaccine as a monotherapy showed that it
was safe and well tolerated and demonstrated encouraging early
efficacy in a head and neck cancer patient and in other
hard-to-treat cancers such as high grade serous ovarian carcinoma
(HGSOC) and triple negative breast cancer (TNBC).
ModiFY is a first-in-human Phase 1/2 basket trial investigating
the use of Modi-1, the first candidate from Scancell's Moditope(R)
platform, to treat four different types of cancer: HGSOC, TNBC,
head and neck squamous cell carcinoma (SCCHN) and renal cell
carcinoma (RCC). A total of up to 138 cancer patients will be
recruited into either the monotherapy groups of the trial, or
treated in combination with standard of care checkpoint inhibitor
(CPI) therapy, or if surgical candidates with SCCHN, they will be
randomised to receive either Modi-1 alone or Modi-1 with
pembrolizumab (Keytruda(R) ).
To date, 23 patients have been vaccinated with Modi-1 and all
have had skin reactions at the injection sites consistent with a
delayed-type hypersensitivity (DTH) reaction indicative of a T cell
response. So far, initial clinical responses have been assessed in
14 patients reaching the first imaging evaluation timepoint at week
8. Of these patients, one has had a confirmed partial response and
seven patients have stable disease, despite having progressive
disease prior to enrolment in the study. As no dose limiting
toxicities were observed in the monotherapy dose escalation
cohorts, patients continue to be enrolled into both the ongoing
monotherapy expansion cohorts and the CPI combination dose
escalation cohorts during H1 2023.
Dr David Pinato, Principal Investigator at Imperial College,
commented: "Advanced ovarian cancer is an aggressive cancer which
is hard to treat. The early efficacy data showing that the Modi-1
vaccine is stabilising this advanced disease is very
encouraging".
Prof Christian Ottensmeier, Chief Investigator, University of
Liverpool commented: "The strong DTH responses in all patients and
the early clinical results, particularly in the patient with
advanced SCCHN, suggests that this therapeutic cancer vaccine could
have significant potential. Further studies with Modi-1 monotherapy
and in combination with CPIs should tell us in which settings it
will have maximum benefit to patients."
Prof Lindy Durrant, Chief Executive Officer, Scancell ,
commented: "We are highly encouraged with the early efficacy data
we have achieved in the ModiFY clinical trial, and safety profile
to date with patients receiving Modi-1. These results allow us to
proceed with the monotherapy expansion cohorts and into the cohorts
in combination with checkpoint inhibitors as planned."
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 HGSOC,
SCCHN, TNBC or RCC. 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
CPIs 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 is recruiting patients to
receive Modi-1 plus a CPI. To date, 23 patients have been
vaccinated, 18 with HGSOC, two with TNBC, two with SCCHN and one
with RCC, with 55 doses being administered in total.
Further information relating to the clinical trial can be found
on the Company's website at www.scancell.co.uk and at
https://clinicaltrials.gov
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
For further information, please contact:
+44 (0) 20 3727
Scancell Holdings plc 1000
Dr Jean-Michel Cosséry, Non-Executive Chairman
Professor Lindy Durrant, CEO
Stifel Nicolaus Europe Limited (Nominated Adviser +44 (0) 20 7710
and Joint Broker) 7600
Nicholas Moore/Samira Essebiyea/William Palmer-Brown
(Healthcare Investment Banking)
Nick Adams/Nick Harland (Corporate Broking)
+44 (0) 20 7886
Panmure Gordon (UK) Limited (Joint Broker) 2500
Freddy Crossley/Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
+44 (0) 20 3727
FTI Consulting 1000
Simon Conway/Rob Winder/Alex Davis
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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