LEEDS, England, April 29, 2019 /PRNewswire/ -- 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® (pembrolizumab)
The first patient participating in the combination phase I/II
study of MRx0518 and *KEYTRUDA® 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 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.
In addition to the monotherapy study, the combination phase I/II
study of MRx0518 and Keytruda® in collaboration with
Merck & Co., Inc., Kenilworth,
NJ., USA, for patients who have relapsed or are refractory
to PD-1 inhibitors is progressing as expected. 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 significantly strengthens
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."
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® 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® 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/
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