REG - Scancell Hlds - ModiFY Phase 1/2 poster presentation at AACR 2023

Scancell HoldingsAnnouncement

18/04/2023 07:00

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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(®) platform, to treat four different
types of cancer: high 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 (https://www.abstractsonline.com/pp8/#!/10828/presentation/10452)
 Poster presentation title  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
 Session title              Phase I and First-in-Human Clinical Trials in Progress
 Session date and time      13:30 - 17:30 ET, 18 April 2023
 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
(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)

 FTI Consulting                                                               +44 (0) 20 3727 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(®), 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 (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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