4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces the opening of a clinical study to evaluate the safety and preliminary clinical efficacy of MRx0518 in combination with preoperative radiotherapy in 15 patients with resectable pancreatic cancer.
The study is being conducted at The University of Texas MD Anderson Cancer Center and is the second opened as part of a strategic collaboration to evaluate 4D's Live Biotherapeutic oncology pipeline across a range of cancer settings. Cullen M. Taniguchi, M.D., Ph.D., Assistant Professor of Radiation Oncology at MD Anderson, is the principal investigator for the study.
Subjects will be dosed daily with MRx0518 for one week prior to and throughout radiotherapy, up until 24 hours prior to surgical resection. In addition to the primary endpoint of safety and tolerability, the study will evaluate the preliminary clinical efficacy of the combination including assessment of major pathologic response, Progression Free Survival (PFS) and Overall Survival (OS). Additional secondary and exploratory endpoints will assess changes in tumour infiltrating lymphocytes (TILs) and the gut microbiome.
Alex Stevenson, 4D's Chief Scientific Officer, commented:
"Pancreatic cancer carries a poor prognosis and remains an area of significant unmet need. Encouraged by promising early signals in our other clinical studies, we believe MRx0518 has the potential to offer new treatment options and dramatically improve outcomes for patients with pancreatic cancer. This third study demonstrates 4D's ongoing commitment to oncology."
4D recently announced clinical observations from its ongoing open-label study of MRx0518 in combination with KEYTRUDA® (pembrolizumab) in patients with solid tumours that have progressed on prior checkpoint inhibitor therapy with no known alternative treatment options. The combination is well tolerated with no drug-related adverse events, and currently has induced partial responses in two of six evaluable patients and stable disease in a third patient.
Founded in February 2014, 4D pharma 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 bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform, MicroRx®, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism.
4D's Live Biotherapeutic Products are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has five clinical studies in progress, namely a Phase II clinical study of BLAUTIX® in Irritable Bowel Syndrome (IBS), a Phase I/II study of MRx0518 in combination with KEYTRUDA® (pembrolizumab) in solid tumours, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumours, a Phase I study of MRx0518 in patients with pancreatic cancer and a Phase I/II study of MRx-4DP0004 in asthma. Preclinical-stage programmes include candidates for CNS disease such as Parkinson's disease and other neurodegenerative conditions. The Company has a research collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics for vaccines.
For more information, refer to https://www.4dpharmaplc.com.
MRx0518, a product of 4D's discovery platform MicroRx®, is a single strain Live Biotherapeutic Product (LBP) in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body's immune system, directing it to produce cytokines and immune cells that are known to attack tumours.
It is currently being evaluated in three clinical trials in cancer patients. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumours and is being conducted at Imperial College (London, UK). MRx0518-I-002 is in combination with KEYTRUDA® (pembrolizumab) in collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is a study in combination with radiotherapy in patients with resectable pancreatic cancer.