4D pharma Presents Trial in Progress Poster on the Phase II Study of MRx0518 in Combination with BAVENCIO® in Patients with Unresectable Locally Advanced or Metastatic Urothelial Carcinoma at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting
– Study to assess safety of MRx0518 with BAVENCIO and effect on progression-free survival at 6 months
– Study sites are open for patient enrolment
Leeds, UK, May 27, 2022 – 4D pharma plc (AIM: DDDD, NASDAQ: LBPS) , a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announced the presentation of a trial in progress poster from the Phase II clinical trial of MRx0518 in combination with BAVENCIO® (avelumab), a PD-L1 blocking antibody, as a first-line maintenance therapy for patients with unresectable locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
“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 Alex Stevenson, Chief Scientific Officer at 4D pharma. “MRx0518 has previously demonstrated single agent immuno-modulation of the tumor microenvironment, and this data supports the potential of this combination to significantly enhance and improve outcomes for patients beyond treatment with BAVENCIO alone. Not only are we able to evaluate MRx0518 with a leading immune checkpoint inhibitor, we are also able to assess its potential in earlier treatment settings. We are pleased to be sharing further details on the design of our first-line maintenance study with BAVENCIO for the treatment of locally advanced or metastatic urothelial carcinoma with the oncology medical community at ASCO.”
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 : Amishi Y. Shah MD, The University of Texas MD Anderson Cancer Center, Houston, TX
Session Title : Genitourinary Cancer – Kidney and Bladder
Abstract Number : TPS4610
Poster Number : 95a
Date and Time : Saturday, June 4, 2022 at 13:15 CDT
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 Merck KGaA, Darmstadt, Germany and Pfizer Inc.
· Study sites are open for patient enrolment.
The poster will be available on the “Posters & Publications” section of the 4D pharma website at www.4dpharmaplc.com.
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 Imperial College (London, UK). MRx0518-I-002 is in combination with KEYTRUDA® (pembrolizumab) in patients with acquired resistance to prior anti-PD-1/PD-L1 immune checkpoint therapies. The Coordinating Investigator of the study is at The University of Texas MD Anderson Cancer Center, Houston, USA, with multiple additional sites in the US. The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is in combination with preoperative radiotherapy in resectable pancreatic cancer. MRx0518-004 (AVENU) is a Phase II clinical trial of MRx0518 in combination with BAVENCIO® (avelumab) in the first-line maintenance setting for urothelial carcinoma, conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc.
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®, 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® (pembrolizumab) in solid tumors, a Phase II clinical trial of MRx0518 in combination with BAVENCIO® (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® 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 (Merck & Co., Inc., Kenilworth, NJ, USA), to discover and develop Live Biotherapeutics for vaccines.
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