REG - Scancell Hlds - Modi-1 Phase 1/2 trial open for recruitment

Scancell HoldingsAnnouncement

11/04/2022 07:01

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RNS Number : 8575H  Scancell Holdings Plc  11 April 2022

11 April 2022

 

Scancell Holdings plc

("Scancell" or the "Company")

 

Modi-1 Phase 1/2 clinical trial open for recruitment

 

First-in-human clinical trial in patients with triple negative breast cancer,
ovarian cancer, head and neck cancer, and renal cancer

 

Early safety and immunogenicity data expected to be available in H2 2022

 

 

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for
the treatment of cancer and infectious disease, today announces that its Phase
1/2 clinical trial with Modi-1 (ModiFY) is open for recruitment.

 

In addition, the UK's Medicines and Healthcare Products Regulatory Authority
(MRHA) has approved a protocol amendment which is aimed at accelerating
patient recruitment and shortening study timelines. The study is a
first-in-human clinical trial in patients with triple negative breast cancer,
ovarian cancer, head and neck cancer, and renal cancer. Modi-1 will be
administered alone and in combination with checkpoint inhibitors (CPIs) in
patients where the CPI is standard of care. As previously announced, the
Company expects early safety and immunogenicity data to be available in H2
2022 and potential efficacy data in 2023.

 

Leading oncology clinical research sites and investigators across the UK have
agreed to contribute patients to the ModiFY study. The first wave of clinical
sites is now open for recruitment and in due course the Company expects up to
20 sites to be open and recruiting patients.

 

Modi-1, the first candidate in Scancell's Moditope(®) platform, consists of
three citrullinated tumour-associated peptides exploiting the normal immune
response to stressed cells, which is largely mediated by cytotoxic CD4 T
cells. The peptides are linked to AMPLIVANT(®), a potent adjuvant which, in
preclinical models, enhanced the immune response of Modi-1 10-to-100 fold and
resulted in highly efficient tumour clearance, including protection against
tumour recurrence. AMPLIVANT(®) is the subject of a worldwide licensing and
collaboration agreement with ISA Pharmaceuticals for the manufacturing,
development and commercialisation of Modi-1.

 

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "The opening
of recruitment for patients into our ModiFY clinical trial is a major step
forward for the Company. We are very excited about the prospects for Modi-1
based on the dramatic regression of large tumours in our preclinical models
and look forward to accelerating recruitment over the coming months and
analysing the early safety and immunogenicity data later this year."

 

Professor Christian Ottensmeier at The Clatterbridge Cancer Centre and
University of Liverpool, commented: "As the principal investigator for this
first-in-human clinical trial I am delighted to be working with Scancell to
explore how this novel immunotherapy, Modi-1, could improve the prognosis for
patients with hard-to-treat tumours."

 

Professor Kees Melief, Chief Scientific Officer, ISA Pharmaceuticals,
commented: "This is an important milestone further cementing the productive
collaboration we have with Scancell. The trial provides a further opportunity
to demonstrate the potent adjuvant properties that AMPLIVANT(®) confers on
therapeutic vaccines to potentiate the immune response needed to attack these
cancers effectively."

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014 (MAR).

 

 

 For further information, please contact:

 Scancell Holdings plc                                                 +44 (0) 20 3727 1000
 Dr John Chiplin, Executive Chairman
 Professor Lindy Durrant, CEO

 Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker)      +44 (0) 20 7886 2500
 Freddy Crossley/Emma Earl (Corporate Finance)
 Rupert Dearden (Corporate Broking)

 Stifel Nicolaus Europe Limited (Joint Broker)                         +44 (0) 20 7710 7600
 Nicholas Moore / Samira Essebiyea / William Palmer-Brown (Healthcare
 Investment Banking)
 Nick Adams / Nick Harland (Corporate Broking)

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