4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of live biotherapeutics, today announced that the Company has submitted, and the Medicines and Healthcare products Regulatory Agency (MHRA) has cleared, a Clinical Trial Application for MRx0518, the Company's live biotherapeutic for the treatment of cancer. Enrolment in the Phase 1b study is expected to commence in the second half of 2018.
The first-in-human, two-part Phase Ib study will evaluate the safety, tolerability and anti-tumour immuno-modulatory effects of MRx0518 in patients with multiple solid tumour types. Patients enrolled in the study will not have received any previous cancer therapies and will receive MRx0518 for the period between diagnosis and surgical resection. In part A of the study, 20 patients will receive MRx0518 open label twice daily prior to surgery. In part B, up to 100 patients will receive MRx0518 and 20 patients will receive placebo prior to surgery. In addition to assessing safety and tolerability, tumour, blood and stool samples will be taken before and after treatment to investigate the effect of MRx0518 on a range of immunological markers and the gut microbiome. Survival will also be investigated up to two years post-surgery.
Duncan Peyton, 4D's Chief Executive Officer, commented: "This groundbreaking study is set to be the world's first live biotherapeutic clinical trial in oncology and the first of a number of studies we have planned to investigate MRx0518 in multiple cancer settings. The novel design of this trial provides an unrivalled opportunity to evaluate the immuno-modulatory properties of MRx0518 and how our approach using live biotherapeutics could advance a new approach to the understanding of the treatment of cancer."