4D Pharma has initiated a clinical study to assess the preliminary clinical efficacy of MRx0518 in combination with preoperative radiotherapy for treating resectable pancreatic cancer.
The study is conducted at The University of Texas MD Anderson Cancer Center and includes 15 patients.
MRx0518 is a single strain Live Biotherapeutic Product (LBP) that is delivered as an oral capsule. It is developed to stimulate the immune system triggering cytokine and immune cell production to target tumours.
Under the new study, patients will be administered with MRx0518 for one week prior to and throughout radiotherapy. The programme will continue until 24 hours before the scheduled surgical resection.
The study will primarily assess safety and tolerability on the subjects, including major pathologic response, Progression-Free Survival (PFS) and Overall Survival (OS).
Secondary endpoints include evaluation of changes in tumour infiltrating lymphocytes (TILs) and the gut microbiome.
4D chief scientific officer Alex Stevenson said: “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 is MRx0518’s third clinical trial on cancer patients.
Established in 2014, 4D Pharma is engaged in the development of Live Biotherapeutics, an emerging class of drugs that contain a live organism to treat a disease.
In November last year, the company reported initial data from an ongoing Phase I/II clinical trial of a combination of its MRx0518 with MSD’s Keytruda. The trial involved assessing the efficacy of the combination on multiple cancer types.