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4d Pharma PLC
07 January 2019
4D pharma plc
(the "Company" or "4D")
Collaboration with MD Anderson Cancer Center
4D pharma and MD Anderson Cancer Center to Evaluate Live
Biotherapeutics in Solid Tumours
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(R) 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."
For further information please contact:
4D
Duncan Peyton, Chief Executive Officer + 44 (0)113 895 0130
Fay Weston, Head of Investor Relations + 44 (0)7990 381713
Zeus Capital Limited - Nomad and Joint Broker +44 (0) 161 831 1512
Dan Bate / Jordan Warburton
Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332 2500
Dominic Wilson / Phil Walker
MD Anderson Cancer Center: +1 713 745 1898
Ron Gilmore
Email: rlgilmore1@mdanderson.org
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(R) 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(R)
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(R) 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).
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
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of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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