Earlier this year, 4D Pharma Plc. (“4D Pharma”) experienced a “win” when the FDA approved the company’s plans to initiate a Phase 1 clinical trial evaluating MRx0005 and MRx0029 for Parkinson’s disease. Now, shares Clinical Trials Arena, 4D Pharma has experienced more positive results. This time, the data comes from the second part of a Phase 1/2 clinical trial, through which the company has been evaluating MRx0518 and Keytruda for patients with renal cell carcinoma (RCC).
The Clinical Trial
Within this Phase 1/2 clinical trial, researchers have sought to understand the safety, efficacy, and tolerability of Keytruda and MRx0518 for RCC. Keytruda (pembrolizumab) is a humanized antibody used in immunotherapy to treat a variety of different forms of cancer. It is administered intravenously. MRx0518 is described as:
a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium.
This therapy, MRx0518, is given via pills. Currently, 4D Pharma, alongside Merck, are engaging in this clinical trial. Enrolled patients have solid tumors whose condition advanced following immune checkpoint inhibitor therapies. So far, 47 patients have enrolled. However, the companies aim to enroll a total of 120 patients.
So far, MRx0518 has shown to be relatively safe and effective. Patients also seem to tolerate the treatment well. Interim data suggests that the treatment improves progression-free survival and helps maintain disease stability for at least 6+ months.
About Renal Cell Carcinoma (RCC)
Renal cell carcinoma (RCC) is a rare kidney cancer that manifests in the lining of small tubes within the kidneys. Typically, the tumor forms on one kidney, though it can be found on both. RCC also metastasizes easily and may spread throughout the body to the lungs and other areas. Despite its rare nature, RCC is also considered the most common form of adult kidney cancer.
While the cause of RCC is unknown, there have been some factors associated with an increased risk. These include a history of kidney problems, smoking cigarettes, gene mutations (PRC, TFE 3, VHL), being male, and being older in age. Renal cell carcinoma often manifests between ages 50-70. Often, symptoms do not occur until the cancer has metastasized. When symptoms appear, these may include:
- Fever
- Hematuria (bloody urine) or rust-colored urine
- Appetite loss
- Unintended weight loss
- High blood pressure
- Fatigue and general weakness
- Abdominal pain and/or a mass in the abdomen
- Enlarged testicle(s)
- Anemia (low red blood cell count)
