RE: Great news16 Aug 2022 15:18
Thanks GF
First patient dosed in Cohort 2 of the ModiFY
Tue, 16th Aug 2022 14:00
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).