4D Pharma Announces Opening of a Study Investigating MRx0518
in Combination with Radiotherapy in Patients with Resectable
Pancreatic Cancer
LEEDS, England, Jan. 6, 2020 /PRNewswire/ -- 4D pharma plc (AIM:
DDDD), a pharmaceutical company leading the development of Live
Biotherapeutics, today announces the opening of a clinical study to
evaluate the safety and preliminary clinical efficacy of MRx0518 in
combination with preoperative radiotherapy in 15 patients with
resectable pancreatic cancer.
The study is being conducted at The University of Texas MD Anderson Cancer Center and
is the second opened as part of a strategic collaboration to
evaluate 4D's Live Biotherapeutic oncology pipeline across a range
of cancer settings. Cullen M.
Taniguchi, M.D., Ph.D., Assistant Professor of Radiation
Oncology at MD Anderson, is the principal investigator for the
study.
Subjects will be dosed daily with MRx0518 for one week prior to
and throughout radiotherapy, up until 24 hours prior to surgical
resection. In addition to the primary endpoint of safety and
tolerability, the study will evaluate the preliminary clinical
efficacy of the combination including assessment of major
pathologic response, Progression Free Survival (PFS) and Overall
Survival (OS). Additional secondary and exploratory endpoints will
assess changes in tumour infiltrating lymphocytes (TILs) and the
gut microbiome.
Alex Stevenson, 4D's Chief
Scientific Officer, commented:
"Pancreatic cancer carries a poor prognosis and remains an
area of significant unmet need. Encouraged by promising early
signals in our other clinical studies, we believe MRx0518 has the
potential to offer new treatment options and dramatically improve
outcomes for patients with pancreatic cancer. This third study
demonstrates 4D's ongoing commitment to oncology."
4D recently announced clinical observations from its ongoing
open-label study of MRx0518 in combination with KEYTRUDA®
(pembrolizumab) in patients with solid tumours that have progressed
on prior checkpoint inhibitor therapy with no known alternative
treatment options. The combination is well tolerated with no
drug-related adverse events, and currently has induced partial
responses in two of six evaluable patients and stable disease in a
third patient.
About 4D
Founded in February 2014, 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 has developed a proprietary platform,
MicroRx®, that rationally identifies Live Biotherapeutics based on
a deep understanding of function and mechanism.
4D's Live Biotherapeutic Products are orally delivered single
strains of bacteria that are naturally found in the healthy human
gut. The Company has five clinical studies in progress, namely a
Phase II clinical study of BLAUTIX® in Irritable Bowel Syndrome
(IBS), a Phase I/II study of MRx0518 in combination with KEYTRUDA®
(pembrolizumab) in solid tumours, a Phase I study of MRx0518 in a
neoadjuvant setting for patients with solid tumours, a Phase I
study of MRx0518 in patients with pancreatic cancer and a Phase
I/II study of MRx-4DP0004 in asthma. Preclinical-stage programmes
include candidates for CNS disease such as Parkinson's disease and
other neurodegenerative conditions. The Company has a research
collaboration with MSD, a tradename of Merck & Co., Inc.,
Kenilworth, NJ, USA, to discover
and develop Live Biotherapeutics for vaccines.
For more information, refer to https://www.4dpharmaplc.com.
About MRx0518
MRx0518, a product of 4D's discovery platform MicroRx®, is a
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 tumours.
It is currently being evaluated in three clinical trials in
cancer patients. MRx0518-I-001 is a neoadjuvant monotherapy study
in a variety of solid tumours and is being conducted at Imperial
College (London, UK).
MRx0518-I-002 is in combination with KEYTRUDA®
(pembrolizumab) in collaboration with MSD, a tradename of Merck
& Co., Inc., Kenilworth, NJ,
USA. MRx0518-I-003 is a study in combination with radiotherapy in
patients with resectable pancreatic cancer.