REG - Scancell Hlds - Encouraging early efficacy data from ModiFY trial

Scancell HoldingsAnnouncement

21/02/2023 07:00

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RNS Number : 4947Q  Scancell Holdings Plc  21 February 2023

21 February 2023

 

Scancell Holdings plc

("Scancell" or the "Company")

 

Encouraging early efficacy data from monotherapy part of ModiFY Phase 1/2
clinical trial

 

Modi-1 cancer vaccine showed partial response and stable disease in patients
with hard-to-treat head and neck, high grade serous ovarian or triple negative
breast cancers

 

First clinical candidate from Moditope(®) platform well tolerated with no
dose limiting toxicities

 

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for
the treatment of cancer and infectious disease, today announces completion of
the monotherapy dose finding arm of the multicentre Phase 1/2 ModiFY clinical
trial. Data from patients receiving the Modi-1 cancer vaccine as a monotherapy
showed that it was safe and well tolerated and demonstrated encouraging early
efficacy in a head and neck cancer patient and in other hard-to-treat cancers
such as high grade serous ovarian carcinoma (HGSOC) and triple negative breast
cancer (TNBC).

 

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: HGSOC, TNBC, head and neck squamous cell
carcinoma (SCCHN) and renal cell carcinoma (RCC). A total of up to 138 cancer
patients will be recruited into either the monotherapy groups of the trial, or
treated in combination with standard of care checkpoint inhibitor (CPI)
therapy, or if surgical candidates with SCCHN, they will be randomised to
receive either Modi-1 alone or Modi-1 with pembrolizumab (Keytruda(®)).

 

To date, 23 patients have been vaccinated with Modi-1 and all have had skin
reactions at the injection sites consistent with a delayed-type
hypersensitivity (DTH) reaction indicative of a T cell response. So far,
initial clinical responses have been assessed in 14 patients reaching the
first imaging evaluation timepoint at week 8. Of these patients, one has had a
confirmed partial response and seven patients have stable disease, despite
having progressive disease prior to enrolment in the study. As no dose
limiting toxicities were observed in the monotherapy dose escalation cohorts,
patients continue to be enrolled into both the ongoing monotherapy expansion
cohorts and the CPI combination dose escalation cohorts during H1 2023.

 

Dr David Pinato, Principal Investigator at Imperial College, commented:
"Advanced ovarian cancer is an aggressive cancer which is hard to treat. The
early efficacy data showing that the Modi-1 vaccine is stabilising this
advanced disease is very encouraging".

 

Prof Christian Ottensmeier, Chief Investigator, University of Liverpool
commented: "The strong DTH responses in all patients and the early clinical
results, particularly in the patient with advanced SCCHN, suggests that this
therapeutic cancer vaccine could have significant potential. Further studies
with Modi-1 monotherapy and in combination with CPIs should tell us in which
settings it will have maximum benefit to patients."

 

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "We are
highly encouraged with the early efficacy data we have achieved in the ModiFY
clinical trial, and safety profile to date with patients receiving Modi-1.
These results allow us to proceed with the monotherapy expansion cohorts and
into the cohorts in combination with checkpoint inhibitors as planned."

 

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. To date, 23 patients have been
vaccinated, 18 with HGSOC, two with TNBC, two with SCCHN and one with RCC,
with 55 doses being administered in total.

 

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)

 

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 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 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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