Scancell Holdings Plc ModiFY Phase 1/2 poster presentation at AACR 2023 (4987W)
2023年4月18日 - 3:00PM
ＲＮＳを含む英国規制内ニュース （英語）
TIDMSCLP
RNS Number : 4987W
Scancell Holdings Plc
18 April 2023
18 April 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 Association
for Cancer Research Annual Meeting
Scancell Holdings plc (AIM: SCLP), the developer of novel
immunotherapies for the treatment of cancer and infectious disease,
announces it will today 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 carcinoma: protocol for the ModiFY phase I/II basket
clinical trial" at the American Association for Cancer Research
(AACR) 2023 Annual Meeting taking place at the Orange County
Convention Center in Orlando, Florida, US between 14-19 April
2023.
The poster being presented by Fayaz Master, Head of Clinical
Operations, describes the protocol and introduces the concept of
citrullination as a good target for cancer vaccines. This is
exemplified by presenting the results reported by the Company on 21
February on the ModiFY trial. This 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).
The poster, which includes data up until the date of the poster
acceptance by AACR, concludes that Modi-1 is well tolerated and
that the early efficacy data from the monotherapy arm of the trial
is encouraging. Safety and early efficacy data are supportive of
the current ongoing sub-studies with Modi-1 in combination with
standard of care checkpoint inhibitor (CPI) therapy. Over 20
patients had been vaccinated with Modi-1 and all had skin reactions
at the injection sites consistent with a delayed-type
hypersensitivity (DTH) reaction indicative of a T cell response.
Initial clinical responses had been assessed in 14 patients
reaching the first imaging evaluation timepoint at week 8. Of these
patients, one had a confirmed partial response and seven patients
had had stable disease, despite having progressive disease prior to
enrolment in the study.
The ModiFY study is ongoing and recruiting patients into the
Phase 2a sub-study investigating Modi-1 monotherapy in dose
expansion cohorts. In tandem, patients are being screened for
treatment with Modi-1 in combination with standard of care CPI
therapy. The safety, efficacy and immunology of Modi-1 will
continue to be evaluated in up to 138 cancer patients within the
master protocol.
The title, timing and location of the poster presentation are as
follows:
Abstract CT256/19
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 carcinoma: protocol for the ModiFY
phase I/II basket clinical trial
Session title Phase I and First-in-Human Clinical Trials in
Progress
Session date and 13:30 - 17:30 ET, 18 April 2023
time
Location Orange County Convention Center, Section 46,
Poster Board Number 19
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:
+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 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.
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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April 18, 2023 02:00 ET (06:00 GMT)
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
