A new study will evaluate the preliminary clinical efficacy of MRx0518 in combination with preoperative radiotherapy in patients with resectable pancreatic cancer and assess changes in tumour infiltrating lymphocytes and the gut microbiome.
The research is being conducted at The University of Texas MD Anderson Cancer Center, USA, and is the second opened as part of a strategic partnership to evaluate 4D’s Live Biotherapeutic oncology pipeline across a range of cancer settings. Cullen M Taniguchi, MD, PhD, Assistant Professor of Radiation Oncology at MD Anderson, is the lead investigator for the study.
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.”
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.
Subjects of this study 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 research 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.
4D have 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.