Scancell, the developer of novel immunotherapies for the treatment of cancer and infectious disease and Calculus portfolio company, today announces that the first patient in Cohort 2 of the multicentre Phase 1 Modi-1 clinical trial (ModiFY) has been enrolled 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.
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.”