Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF) said its Phase 1/2 clinical trial with Modi-1 (ModiFY) is open for recruitment.
Leading oncology clinical research sites and investigators across the UK have agreed to contribute patients to the ModiFY study. The first wave of clinical sites is now open for recruitment and in due course the company expects up to 20 sites to be open and recruiting patients.
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 and in combination with checkpoint inhibitors (CPIs) in patients where the CPI is the standard of care. As previously announced, the company expects early safety and immunogenicity data to be available in the second half of this year with potential efficacy data to follow in 2023.
"The opening of recruitment for patients into our ModiFY clinical trial is a major step forward for the company. We are very excited about the prospects for Modi-1 based on the dramatic regression of large tumours in our preclinical models and look forward to accelerating recruitment over the coming months and analysing the early safety and immunogenicity data later this year,” said Professor Lindy Durrant, the chief executive officer of Scancell.
Professor Christian Ottensmeier at The Clatterbridge Cancer Centre and University of Liverpool, who is the principal investigator for this clinical trial, said Modi-1 could improve the prognosis for patients with hard-to-treat tumours.