First patient dosed in Cohort 2 of the ModiFY

RNS Number : 2138W

Scancell Holdings Plc

16 August 2022

 

16 August 2022

Scancell Holdings plc

("Scancell" or the "Company")

First patient dosed in Cohort 2 of the ModiFY Phase 1 clinical trial

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

Further 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 the first patient in Cohort 2 of the multicentre Phase 1 Modi-1 clinical trial (ModiFY) has been enroled and dosed. The dosing follows approval of the dose escalation by the Safety Review Board. The ModiFY study is a first-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer. In the trial, Modi-1 will be administered alone or in combination with checkpoint inhibitors (CPIs) in patients with head and neck, triple negative breast and renal tumours.

Modi-1 is the first candidate of Scancell's Moditope^® platform. This open label study will recruit up to 125 patients in up to 20 clinical trial sites across the UK. The objective for Cohort 1 of the trial was to assess the safety of the two citrullinated vimentin peptides at a low starting dose. All three patients have successfully received two doses; the injections were well tolerated with no safety concerns. Patients in Cohort 2 will receive a higher dose of both the two citrullinated vimentin peptides plus a citrullinated enolase peptide.

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 and at https://clinicaltrials.gov

Prof Lindy Durrant, Chief Executive Officer, Scancell , commented: "This is a significant safety milestone for the Company, being the first time a citrullinated peptide vaccine from our Moditope^® platform has been given to cancer patients. We are encourgared  that there were no safety concerns in the initial cohort, allowing us to proceed smoothly with the dose escalation."

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	[phone]
Dr John Chiplin, Executive Chairman
Professor Lindy Durrant, CEO
Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker)	[phone]
Freddy Crossley/Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
Stifel Nicolaus Europe Limited (Joint Broker)	[phone]
Nicholas Moore/ Samira Essebiyea/William Palmer-Brown (Healthcare Investment Banking)
Nick Adams/Nick Harland (Corporate Broking)
FTI Consulting	[phone]
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/

 

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