Scancell Holdings plc announced that the UK's Medicines and Healthcare Products Regulatory Authority (MRHA) has approved the clinical trial application (CTA) to initiate the first-in-human Phase I/II clinical study of Modi-1. The Company expects to enrol patients into the study in H2 21, following ethics committee sign-off. Initial safety/tolerability data from the initial open label portion of the trial could be available from H1 22. The Modi-1 clinical trial will be 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 in combination with checkpoint inhibitors in patients with head and neck or renal tumours. The trial will initially focus on the safety of two citrullinated vimentin peptides and, if there are no significant side effects, a citrullinated enolase peptide will be added. 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 commercialization of Modi-1. The Modi-1 clinical trial will evaluate the first therapeutic vaccine candidate from the Company's novel Moditope platform, which stimulates immune responses to stress induced post-translational modifications (siPTMs). When cells become stressed, they modify their proteins to alert the immune response that there is a problem. One of these modifications is citrullination which is the target for the Modi-1 vaccine. Fast growing cancer cells need a lot of oxygen and nutrients and are always highly stressed. Included in the Modi-1 vaccine are specific T cell epitopes derived from citrullinated vimentin, which is involved in tumour spread, and citrullinated enolase, which is an enzyme that generates nutrients to drive tumour growth. Removal of cells expressing these proteins by vaccine-specific T cells should eradicate the tumour and prevent further spread.