MRx0518 - Monotherapy trial approved

4D pharma plc

(the "Company" or "4D")

MRx0518 - Monotherapy trial approved; the first live biotherapeutic trial in cancer

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."

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About 4D

Founded in February 2014, 4D is a world leader in the development of live biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacteria, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform that rationally identifies novel bacteria that have a precise and evolved therapeutic effect. All of 4D's live biotherapeutic products are orally delivered single strains of bacteria that are naturally found in the healthy human gut. 4D has completed a phase I study in Irritable Bowel Syndrome and has completed dosing in a phase I study in Paediatric Crohn's Disease. It currently has a pipeline of 13 pre-clinical programmes, covering disease areas such as cancer, poorly controlled asthma, autoimmune and CNS disease, and plans to commence four additional clinical studies in 2018.

About MRx0518

MRx0518 is a live biotherapeutic candidate in development for the treatment of multiple solid tumour types. Originally isolated from a healthy individual, MRx0518 is a flagellated bacterium with an immuno-stimulatory host-response profile mediated via the bacterial flagellin through host TLR5 signalling. Through stimulating the human immune system and increasing the diversity of the gut microbiome, MRx0518 has potential to be administered as a monotherapy, combination therapy or in the neoadjuvant setting to treat a range of cancers.