Scancell Holdings Plc Scancell to Present Modi-1 Data at ASCO (4235B)
June 02 2023 - 2:00AM
UK Regulatory
TIDMSCLP
RNS Number : 4235B
Scancell Holdings Plc
02 June 2023
02 June 2023
Scancell Holdings plc
("Scancell" or the "Company")
Scancell to present ModiFY Phase 1/2 cancer vaccine clinical
trial protocol and early efficacy data at the American Society of
Clinical Oncology Meeting
ModiFY trial progressing through monotherapy expansion cohorts
and combination safety cohorts
First patient dosed in Cohort 4 to test high dose Modi-1 in
combination with CPI
Scancell Holdings plc (AIM: SCLP), the developer of novel
immunotherapies for the treatment of cancer and infectious disease,
announces it will present a poster entitled "Modi-1,
anti-citrullinated neoepitope vaccine alone and combined with
checkpoint inhibitors in patients with head and neck, breast, renal
and ovarian cancers: protocol for the ModiFY Phase 1/2 basket
clinical trial: report after completion of monotherapy
dose-finding" at the American Society of Clinical Oncology Meeting
(ASCO) 2023 Annual Meeting taking place at McCormick Place,
Chicago, US between 2-6 June 2023.
The poster, being presented by Dr Robert Miller, Medical
Director, describes the protocol and presents the results after
completion of the monotherapy dose-finding and provides an update
on patients recruited into the monotherapy dose expansion cohorts
and into the checkpoint inhibitor (CPI) combination dose-finding
cohort . 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: h igh grade serous ovarian carcinoma (HGSOC), triple
negative breast cancer (TNBC) , head and neck squamous cell
carcinoma (SCCHN) and renal cell carcinoma (RCC). Data is included
up until the date of the poster acceptance by ASCO and concludes
that Modi-1 is well tolerated and that the early efficacy data from
the monotherapy arms of the trial remain encouraging.
The ModiFY study is ongoing and recruiting patients into the
Phase 2a sub-study investigating Modi-1 monotherapy in dose
expansion cohorts. In tandem, recruitment into Cohort 3 to receive
treatment with low-dose Modi-1 in combination with standard of care
CPI therapy has been completed. Based on review of the safety data
from Cohort 3, dose escalation to Cohort 4 has been approved by the
Safety Review Board and the first patient has been dosed.
The title, timing and location of the poster presentation are as
follows:
Abstract 2566
Poster presentation Modi-1, anti-citrullinated neoepitope vaccine
title alone and combined with checkpoint inhibitors
in patients with head and neck, breast, renal
and ovarian cancers: ModiFY Phase 1/2 basket
clinical trial: eport after completion of monotherapy
dose-finding.
Session title Development Therapeutics - Immunotherapy
Session date and 08:00 AM - 11:00 AM CDT, June 3, 2023
time
Location McCormick Place , Poster Board number 408
Copies of the poster will be available on Scancell's website
following the conference at:
https://www.scancell.co.uk/vaccine-publications
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 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 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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