LEEDS, England and HOUSTON, January 7,
2019 /PRNewswire/ --
4D pharma plc (AIM: DDDD) and The University of Texas MD Anderson Cancer Center today
announced a strategic collaboration to evaluate 4D's Live
Biotherapeutic oncology pipeline across a range of cancer
settings.
The alliance brings together MD Anderson's translational
medicine and clinical research capabilities with 4D's expertise in
the discovery and development of Live Biotherapeutics. The
collaboration will initially assess 4D's lead oncology candidate,
MRx0518, as a potential treatment for solid tumours.
The first clinical study, an open label Phase I study of MRx0518
in combination with Keytruda® and conducted in collaboration with
Merck & Co., Inc., Kenilworth,
NJ., USA, has been initiated and is due to open shortly. The
study will enrol up to 132 patients with metastatic cancer across
multiple histologies (non-small cell lung cancer, renal cell
carcinoma, bladder cancer and melanoma) who have failed prior
anti-PD-1 therapy.
Subsequent studies are also being planned under the
collaboration, including using MRx0518 in combination with
stereotactic body radiotherapy (SBRT) for the treatment of
pancreatic cancer.
Duncan Peyton, 4D's Chief
Executive Officer, commented: "This alliance will provide a strong
and long-term foundation for the development of 4D's Live
Biotherapeutics in cancer."
He added, "The current study, which will be one of the first
Live Biotherapeutic programmes to reach the clinic in the
immuno-oncology space, represents an important step forward in the
development of MRx0518 and 4D's broader oncology franchise.
We look forward to continuing to work with our partners at MD
Anderson to progress this study and help bring this therapy to
patients."
Live biotherapeutics employ strains of gut bacteria that have
been isolated from healthy human donors, and which are
encapsulated, administered orally and delivered to the gut as a
therapeutic. Each strain is selected for its functionality to
perform a specific role in combatting a disease.
"MD Anderson is focused on providing the best possible care for
cancer patients, including implementing the latest new treatment
modalities," said Shubham Pant, MBBS, associate professor of
Investigational Cancer Therapeutics at MD Anderson. "The gut
microbiome has emerged as an important next-generation target in
cancer therapy and we hope that live biotherapeutics will have the
potential to make a significant difference for patients across a
range of cancers."
About 4D
Founded in February 2014, 4D 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 bacteria, that is
applicable to the prevention, treatment or cure of a disease. 4D
has developed a proprietary platform that rationally identifies
novel bacteria that have a precise and evolved therapeutic effect.
All of 4D's live biotherapeutic products are orally delivered
single strains of bacteria that are naturally found in the healthy
human gut. 4D has a phase II study in Irritable Bowel Syndrome
running and has a pipeline of 13 pre-clinical programmes, covering
disease areas such as cancer, poorly controlled asthma, autoimmune
and CNS disease. The Company plans to commence three additional
clinical studies in 2019.
For more information, refer to https://www.4dpharmaplc.com/.
About MRx0518
The microbiome has been implicated in cancer treatment and response
in a range of clinical settings. The microbiome profile of patients
has been demonstrated to drive response to anti-PD-1 therapy in
both melanoma and non-small cell lung cancer. MRx0518 has
demonstrated robust efficacy as an immuno-stimulant and anti-tumour
agent in multiple tumour models such as breast cancer, renal cell
carcinoma and lung cancer.
About Phase I study
This study is pursuant to the clinical collaboration agreement
entered into in June of this year with a subsidiary of Merck Sharpe
& Dohme (tradename of Merck & Co., Inc., Kenilworth, N.J., USA).
The open label Phase I study will evaluate the safety,
tolerability and preliminary clinical benefit of the combination of
MRx0518 and Keytruda® in up to 132 participants who have progressed
on prior PD-1 inhibitor therapy and will take place at the MD
Anderson Cancer Center in Texas,
US.
Participants will receive an intravenous infusion of Keytruda®
every three weeks in combination with two capsules of MRx0518 daily
for up to two years. The primary endpoints are safety,
tolerability, and anti-tumour effect. Other outcome measures will
also be assessed, including overall survival and biomarkers.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
About MD Anderson
The University of Texas MD Anderson
Cancer Center in Houston ranks as
one of the world's most respected centers focused on cancer patient
care, research, education and prevention. The institution's sole
mission is to end cancer for patients and their families around the
world. MD Anderson is one of only 49 comprehensive cancer centers
designated by the National Cancer Institute (NCI). MD Anderson is
ranked No.1 for cancer care in U.S. News & World Report's "Best
Hospitals" survey. It has ranked as one of the nation's top two
hospitals for cancer care since the survey began in 1990 and has
ranked first 14 times in the last 17 years. MD Anderson receives a
cancer center support grant from the NCI of the National Institutes
of Health (P30 CA016672).
For further information please contact:
4D
Duncan Peyton, Chief Executive Officer,
+44(0)113-895-0130
Fay Weston, Head of Investor Relations,
+44(0)799-038-1713
MD Anderson Cancer Center:
Ron Gilmore, +1-713-745-1898, Email:
rlgilmore1@mdanderson.org
SOURCE 4D Pharma PLC