- Study to assess safety of MRx0518 with BAVENCIO and effect on progression-free survival at 6 months
- Study sites are open for patient enrolment
"We are continuing to build a strong body of evidence to support MRx0518 as a novel immunotherapy with broad potential to address significant unmet need across multiple oncology indications," said Dr
Poster Presentation Details:
Poster Title: Trial in progress: A phase II switch maintenance study of live biotherapeutic MRx0518 and avelumab in patients with unresectable locally advanced or metastatic urothelial carcinoma (UC) who did not progress on first-line platinum-containing chemotherapy
Presenting Author:
Session Title: Genitourinary Cancer - Kidney and Bladder
Abstract Number: TPS4610
Poster Number: 95a
Date and Time:
Highlights from the trial in progress poster include:
- The multi-center study (NCT05107427) will enroll 30 patients with unresectable locally advanced or metastatic urothelial carcinoma. Patients must have measurable disease after a partial response (PR) or stable disease (SD) on 4-6 cycles of platinum-containing induction chemotherapy.
- Patients will receive intravenous BAVENCIO (avelumab) every two weeks, in combination with one oral capsule of MRx0518 twice daily, until disease progression, patient withdrawal, or unacceptable toxicity.
- In addition to assessing the safety of the combination of MRx0518 with BAVENCIO, the study will assess the effect of the combination on progression-free survival (PFS) at 6 months.
- Secondary objectives are to assess other efficacy measures including objective response rate (ORR), time to response, duration of response (DOR), disease control rate (DCR), PFS, and overall survival (OS).
- Immunological changes of the microbiome and metabolome will be assessed through biopsies, longitudinal blood sampling and stool and urine samples.
- The study is being conducted in collaboration with
- Study sites are open for patient enrolment.
The poster will be available on the "Posters and Publications" section of the 4D pharma website at www.4dpharmaplc.com.
ENDS
About MRx0518
MRx0518 is single strain Live Biotherapeutic Product (LBP) in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body's immune system, directing it to produce cytokines and immune cells that are known to attack tumors. It is currently being evaluated in four clinical trials in patients with solid tumors. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumors and is being conducted at
About 4D pharma
4D pharma is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D pharma has developed a proprietary platform, MicroRx(R), that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism.
4D pharma's Live Biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has six clinical programs, namely a Phase I/II study of MRx0518 in combination with KEYTRUDA(R) (pembrolizumab) in solid tumors, a Phase II clinical trial of MRx0518 in combination with BAVENCIO(R) (avelumab) in the first-line maintenance setting for urothelial carcinoma, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumors, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, and Blautix(R) in irritable bowel syndrome (IBS) which has completed a successful Phase II trial. A Phase I study of MRx0005 and MRx0029 in patients with Parkinson's disease is expected to commence in 2022. Additional preclinical-stage programs include candidates for CNS disease, immune-inflammatory conditions and cancer. The Company has a research collaboration with MSD (
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