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REG - Scancell Hlds - First patient dosed in expansion phase of ModiFY

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RNS Number : 5757E  Scancell Holdings Plc  31 October 2022

31 October 2022

 

Scancell Holdings plc

("Scancell" or the "Company")

 

First patient dosed in the expansion phase of the monotherapy arms of ModiFY

 

Cohort 3 of ModiFY trial open for recruitment in combination with a CPI

 

Well tolerated safety profile seen with Modi-1 at the higher dose in the
first-in-human clinical trial

 

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for
the treatment of cancer and infectious disease, today announces that the first
patient in the expansion phase of the monotherapy arms in the multicentre
Phase 1 Modi-1 clinical trial (ModiFY) has been enrolled and dosed. In
addition, Cohort 3 of ModiFY is now open for recruitment in combination with a
checkpoint inhibitor (CPI). Expansion into the monotherapy arms and the start
of combination dosing follows review of the safety data from the Cohort 2
patients by the Safety Review Board.

 

The ModiFY study is a first-in-human clinical trial, with Modi-1, the first
candidate from Scancell's Moditope(®) platform, being administered alone or
in combination with CPIs in patients with head and neck, triple negative
breast and renal tumours and as a monotherapy in patients with ovarian cancer,
where there are no approved CPI therapies. This open label study will recruit
up to 125 patients in up to 20 clinical trial sites across the UK.

 

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. All three patients in Cohort 2 have
successfully received two doses and the injections were well tolerated with no
safety concerns. Encouragingly, all three patients showed a delayed type
hypersensitivity response to the vaccine, which is indicative of a T cell
response, and the first patient to be assessed has shown a partial tumour
response at first radiological reassessment. However, this early observation
requires further confirmation with subsequent scans, plus analysis of
responses in the remainder of the Cohort 2 patients.

 

Based on the safety data from Cohort 2, the ModiFY trial will now expand at
this dose for Modi-1 monotherapy in all four tumour types and the first
patient in these expansion cohorts has now been dosed. In parallel, patients
in Cohort 3 will receive Modi-1 plus a CPI to assess if this combination is
safe in patients where CPIs are provided as standard of care. 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. Modi-1 peptides are linked to
AMPLIVANT(®), a potent adjuvant which enhanced the immune response
10-100-fold and resulted in highly efficient tumour clearance, including
protection against tumour recurrence, in preclinical models. AMPLIVANT(®) is
the subject of a worldwide licensing and collaboration agreement with ISA
Pharmaceuticals for the manufacturing, development, and commercialisation of
Modi-1.

 

The Company expects further safety and immunogenicity data to be available in
H2 2022 and early efficacy data in 2023. Further information relating to the
clinical trial can be found on the Company's website at www.scancell.co.uk
(http://www.scancell.co.uk) and at https://clinicaltrials.gov
(https://clinicaltrials.gov) .

 

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "This is an
encouraging milestone for the Company, showing that the higher dose of Modi-1
is generating immune responses that may be having an impact on tumour growth.
We are encouraged that there were no safety concerns in Cohort 2, allowing us
to proceed with the monotherapy expansion and into Cohort 3 in combination
with checkpoint inhibitors, and look forward to announcing further safety and
immunogenicity data in H2 2022."

 

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

 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 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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