The Study: MRx0518-I-003
MRx0518-I-003 is a trial investigating MRx0518 as part of a combination treatment for pancreatic cancer, used with preoperative radiotherapy. The trial will evaluate the therapies safety and efficacy in 15 individuals living with pancreatic cancer.
Each patient will be given one daily dose of MRx0518. The treatment will be given a week before radiotherapy begins, and then continued through the radiotherapy treatment. The combination of both of the therapies will stop 24 hours before the patient undergoes surgical resection.
The trial is taking place at The University of Texas. Its primary endpoints are the safety of the therapy as well as its tolerability. However, progression free survival, overall survival, major pathologic response, tumor infiltrating lymphocytes, and the state of the gut microbiome will also be evaluated.
A 2nd Study
MRx0518 is also being studied with pembrolizumab. This is an ongoing, open-label evaluation for patients who have solid tumors which have continued to progress despite previous checkpoint inhibitor therapy.
So far, the therapy has been shown to produce no AEs and it has been well tolerated for patients.
Although the trial is not yet complete, efficacy results have been positive so far. Out of six patients, there has been a partial response in 2 patients and one patient has reached stable disease.
So what exactly is MRx0518? It is a single strain Live Biotherapeutic Product. It is a part of 4D’s platform called MicroRx.
It is an oral capsule which works by stimulating the immune system, encouraging it to produce immune cells and cytokines. These cells attack the tumors which are harming the body.
In addition to the two trials discussed above, the therapy is also being investigated in a trial called MRx0518-1-001 at Imperial College in London.
You can read more about this investigative therapy here.