Business
First patient dosed in Modi-1 Phase 1 trial
First patient dosed in Modi-1 Phase 1 trial.
About this update from Scancell Holdings Plc
[{"type":"text","content":"\n \n \n 13 June 2022\n \n \n \n \n \n \n Scancell Holdings plc\n \n \n \n (\"Scancell\" or the \"Company\")\n \n \n \n \n \n \n First patient dosed in Modi-1 Phase 1 clinical trial\n \n \n \n \n \n \n \n First-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer\n \n \n \n \n \n \n \n \n \n Early safety and immunogenicity data expected to be available in H2 2022\n \n \n \n \n \n \n Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces the enrolment and treatment of the first patient in its multicentre Modi-1 clinical trial (ModiFY) at Imperial College London, Hammersmith Hospital. The study is a first-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer. 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.\n \n \n \n \n \n Modi-1 is the first candidate in Scancell's Moditope® platform. This open label study will recruit up to 108 patients in up to 20 UK clinical trial sites. The objectives of the initial part of the trial are to assess the safety and immunogenicity of two citrullinated vimentin peptides and, if there are no significant side effects, a citrullinated enolase peptide will be added. In addition, the effect of Modi-1 in promoting T-cell infiltration into the tumour will be assessed in a neoadjuvant cohort in which a further 30 patients with head and neck cancer will be treated with Modi-1 with or without CPI, prior to their first surgical resection.\n \n \n \n \n \n The 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.\n \n \n \n \n \n As previously announced, the Company expects early safety and immunogenicity data to be available in H2 2022 and efficacy data in 2023.\n \n \n \n \n...