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Modi-1 trial open for expansion in CPI combination
Modi-1 trial open for expansion in CPI combination.
About this update from Scancell Holdings Plc
[{"type":"text","content":"\n\n31 July 2023 \n \nScancell Holdings plc\n(\"Scancell\" or the \"Company\")\n \nModi-1 trial open for expansion in combination with checkpoint inhibitors\n· Safety review committee has approved cohort expansion into renal and head and neck patients who receive CPI as standard of care alone and in the neoadjuvant setting\n· Cohort 4 of the ModiFY trial showed that the higher dose Modi-1 in combination with CPI\nwas well tolerated with no safety concerns\n \nScancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, announces that the ModiFY trial is now open for expansion in combination with checkpoint inhibitors (CPI) and in the neoadjuvant setting.\n \nFollowing the successful completion of Cohort 4, where three patients received at least two doses of Modi-1 combined with CPI, the safety review committee has approved expansion into two cohorts of patients with renal or head and neck cancer who receive CPI as standard of care. 21 patients will be recruited into each cohort. Patients with triple negative breast cancer will not be included in this part of the study as these patients receive checkpoints in combination with chemotherapy which may induce citrullination in normal cells and induce toxicity.\n \nAdditionally, recruitment into the neoadjuvant arm of the Modi-1 trial in combination with CPI was also approved. This study will recruit 30 patients who will be randomised at diagnosis to receive either two doses of Modi-1 three weeks apart or two doses of Modi-1 plus one dose of CPI. Tumour biopsies will be taken prior to immunisation and from the tumour resection 6 weeks following the initial vaccination. The two tumour samples will allow the extent of T cell infiltration and activation pre- and post-Modi-1 vaccination to be assessed with and without a checkpoint inhibitor.\n \nModi-1 treatment were well tolerated in Cohort 4 with no safety concerns. Encouragingly, the first patien...