A leading pharmaceutical company 4D Pharma Inc. announced the opening of the clinical study for the evaluation of the safety and clinical efficacy of MRx0518 in combination with preoperative radiotherapy in 15 pancreatic cancer patients.
The recent study is being conducted at the University of Texas MD Anderson Cancer Center. It is the part of the strategic collaboration for the evaluation of 4D’s Live Biotherapeutic oncology course across the wide range of cancer settings. One of the assistant professor of radiation oncology at MD Anderson, Cullen M. Taniguchi is the principal investigator of this study.
This MRx0518 is a product of 4D’s platform MicroRx. It is Live Biotherapeutic Product (LBP), a single strain in the development of cancer treatments. It is an oral capsule that stimulates the immune system directs the production of immune cells and cytokines which attack tumors. Currently under the evaluation of three different clinical trials in pancreatic cancer patients. The study based on neoadjuvant monotherapy in different solid tumors.
4D Pharma is one of the world leaders in making the Live Biotherapeutics, a new emerging drug class which is defined by the U.S. Food and Drug Administration, categorized as the biological products containing live organism like microbe for prevention and treatment of a disease. It has a developed platform, MicroRx which identifies Live Biotherapeutics that is based on a deep understanding of mechanism and function.
15 pancreatic cancers were enrolled in this study. The subjects will be daily dosed with MRx0518 for the whole week before and throughout radiotherapy until 24 hours before the surgical resection. In addition, to the primary endpoint of tolerability and safety of this unique combination which includes an assessment of important pathologic response.
Overall Survival (OS) and Progression-Free Survival (PFS). Moreover, additional secondary and the exploratory endpoints will check changes in the gut microbiome and the tumor-infiltrating lymphocytes (TILS).
The 4D’s Chief Scientific Officer, Alex Stevenson said that pancreatic cancer shows a poor prognosis and significant unmet medical needs. As encouraged by the early promising signals in other clinical studies, they believe that MRx0518 has great potential for new treatments and effective improve outcomes for pancreatic cancer patients. This shows their ongoing commitment to oncology.
4D’s biotherapeutic products are the single strain of live gut-friendly bacteria that are orally delivered. Currently, it has five clinical studies in progress which include a Phase II study of BLAUTIX in Irritable Bowel Syndrome (IBS), a Phase I/II study of MRx0518 with combination of KEYTRUDA in solid tumors, Phase I/II study of MRx-4DP0004 in asthma patients, Phase I study of MRx0518 in pancreatic cancer patients.
It has a research collaboration with MSD which is a tradename of Merck & Co. Inc. for the discovery and development of Live Biotherapeutics vaccines.
4D currently shared its clinical observation based on the open-label study of MRx0518 (in combination with KEYTRUDA) in patients having progressive solid tumors. This combination shows good tolerance with no adverse effects and has induced partial responses and stable disease.