4d Pharma PLC Clinical Update - MRx0518 oncology programmes
29 Aprile 2019 - 08:02AM
RNS Non-Regulatory
TIDMDDDD
4d Pharma PLC
29 April 2019
4D pharma plc
(the "Company" or "4D")
Clinical Update - MRx0518 oncology programmes
4D pharma plc (AIM: DDDD), a pharmaceutical company leading the
development of Live Biotherapeutics, today announces an update on
the clinical progress of its lead oncology Live Biotherapeutic,
MRx0518.
Update on MRx0518 Phase I/II combination study with KEYTRUDA(R)
(pembrolizumab)
The first patient participating in the combination phase I/II
study of MRx0518 and *KEYTRUDA(R) in collaboration with Merck &
Co., Inc., Kenilworth, NJ., USA and 4D's strategic collaboration
with MD Anderson has completed Cycle 1 of Part A of the study with
no dose limiting toxicities. This study is open-label and will
recruit up to 132 patients with metastatic cancer across multiple
cancer types (non-small cell lung cancer, renal cell carcinoma,
bladder cancer and melanoma) who have failed prior anti-PD-1
therapy. Part A of the study will enrol 12 patients with the
primary outcome measure to assess safety and tolerability. Patients
will continue on therapy with follow-up assessments including the
anti-tumour effect of the combination. Recruitment is progressing
as expected and we anticipate completing Part A before the end of
2019. At this point, Part B of the study, which has a primary
endpoint to assess the clinical benefit of the combination, will
commence.
Commencement of Phase I MRx0518 neoadjuvant monotherapy
In addition, our phase I study of MRx0518 in a neoadjuvant
setting has commenced. This placebo-controlled, phase I study at
Imperial College London will evaluate MRx0518 as a monotherapy
neoadjuvant in up to 120 treatment-naïve patients with solid
tumours (melanoma, prostate, breast, ovarian, urothelial/bladder,
renal, lung and head and neck cancers) who are due to undergo
surgery as their first treatment. The primary endpoints of this
study are safety and tolerability with secondary endpoints
including tumour biomarker response, survival, immunological
biomarkers and microbiome profiles. The principal investigator for
this study is Dr. Jonathan Krell.
This study builds on the recently published data on the
mechanism of action of MRx0518 that identified the bacterial
flagellin (a specific component of the bacterium) as a potent
stimulant of the innate and adaptive immune systems that interacts
with the host TLR5 pathway known to be associated with the body's
response to cancer. Oncology is a core area of development at 4D
and the focus on expanding clinical programmes in this space
demonstrates 4D's commitment to this disease area.
Duncan Peyton, 4D's Chief Executive Officer, commented: "We are
delighted with the clinical progress of our oncology programme. The
first patient completing Cycle 1 with no dose limiting toxicities
gives us confidence that we may be able to report on early results
of this study this year. The commencement of the monotherapy study
will significantly strengthen our understanding of the potential of
MRx0518 to impact treatment across a range of cancer settings. The
novel study design will, for the first time, enable the evaluation
of the anti-tumour immunological effects of a Live Biotherapeutic
in treatment-naïve patients who will not be receiving concurrent
therapy. We see our continued research and focus on the mechanism
of action of our Live Biotherapeutic products as crucial to their
further clinical development and regulatory approval as we build
our oncology franchise."
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
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 a bacterium, that is applicable to the
prevention, treatment or cure of a disease. 4D has developed a
proprietary platform that rationally identifies novel bacteria
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. 4D has
three clinical studies in progress, namely a phase II clinical
study of Blautix in Irritable Bowel Syndrome, a phase I/II study of
MRx0518 in combination with Keytruda(R) in solid tumours and a
phase I study of MRx0518 in a neoadjuvant setting for patients with
solid tumours. Other focus programmes include disease areas such as
asthma and CNS disease.
About Cancer
Cancer is a group of diseases involving abnormal cell growth
with the potential to invade or spread to other parts of the body.
Globally, it is estimated that there were around 18 million new
cases in 2018 and that almost 10 million people died of cancer,
making it the leading cause of death world-wide. The number of new
cancer cases per year is expected to rise to 23.6 million by 2030.
The global market for oncology drugs is expected to reach $111.9bn
by 2020.
The microbiome has been implicated in cancer treatment and
response in a range of clinical settings including standard
chemotherapy. 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.
About MRx0518
As both a monotherapy and in combination settings 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. MRx0518 acts on both the innate and
adaptive immune system to induce a response mediated by TLR-5.
The Company is investigating MRx0518 across a range of clinical
cancer settings in 2019. In collaboration with Merck, Sharpe &
Dohme (Merck & Co. Inc), MRx0518 is being evaluated in an open
label Phase I/II study of MRx0518 in combination with Keytruda(R)
in patients with solid tumours who have failed prior anti-PD-1
therapy. A phase I randomised, placebo-controlled study of MRx0518
as a monotherapy in a neoadjuvant setting for solid tumours has
also commenced.
For more information, refer to https://www.4dpharmaplc.com/
*KEYRUDA(R) is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA
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