REG - Scancell Hlds - Scancell to Present Modi-1 Data at ASCO

Scancell HoldingsAnnouncement

02/06/2023 07:00

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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(®) 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). 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 (https://meetings.asco.org/abstracts-presentations/221736)
 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 cancers: ModiFY Phase 1/2 basket clinical trial: eport after
                            completion of monotherapy dose-finding.
 Session title              Development Therapeutics - Immunotherapy
 Session date and time      08:00 AM - 11:00 AM CDT, June 3, 2023
 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
(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(®), 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 (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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