4D pharma announced 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 tumor infiltrating lymphocytes (TILs) and the gut microbiome.

"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," Alex Stevenson, 4D's Chief Scientific Officer, said. "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 tumors 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.

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