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RNS Number : 1467X
4d Pharma PLC
26 August 2020
4D pharma plc
(the "Company" or "4D")
4D pharma announces comprehensive clinical benefit data from
Part A of combination trial of MRx0518 and Keytruda(R)
Leeds, UK, August 26, 2020 - 4D pharma plc (AIM: DDDD), a
pharmaceutical company leading the development of Live
Biotherapeutics, today announces the complete clinical benefit
analysis from Part A of its Phase I/II clinical trial of Live
Biotherapeutic candidate MRx0518 in combination with immune
checkpoint inhibitor (ICI) Keytruda(R) (pembrolizumab), the
anti-PD-1 therapy of MSD, a tradename of Merck & Co., Inc.,
Kenilworth, NJ, USA, in heavily pre-treated patients with solid
tumours.
In 12 patients with metastatic renal cell carcinoma (mRCC) and
metastatic non-small cell lung cancer (mNSCLC), the combination of
MRx0518 with KEYTRUDA achieved a disease control rate (DCR) of 42%,
with five of 12 patients experiencing a clinically meaningful
benefit from the combination. Three patients experienced partial
responses (PR), defined as target tumour shrinkage of 30% or
greater - an objective response rate (ORR) of 25%. MRx0518 in
combination with KEYTRUDA induced durable stable disease (SD) of
six months or greater in an additional two patients (17%). Median
duration of treatment for the five patients experiencing clinical
benefit is now 13.2 months, with four of these patients currently
ongoing.
As previously reported, MRx0518 demonstrated a highly favourable
safety profile, with no treatment-related serious adverse events
(SAEs) or drug discontinuations and, importantly, no increase of
immune-related adverse events (irAEs) commonly associated with ICI
therapy.
Prof. Jaap Verweij, Emeritus Professor of Medical Oncology, at
Erasmus University Medical Center in Rotterdam, the Netherlands,
former chair of the Response Evaluation Criteria in Solid Tumors
(RECIST) working group, and an advisor to the Company said, "Having
been a clinical investigator on over 150 early stage trials with a
wide variety of anti-cancer agents, I believe that these results
are extremely encouraging, particularly given the novelty of the
approach and the durability of clinical benefit observed."
Dr Alex Stevenson, Chief Scientific Officer, 4D pharma,
commented, "The disease control rate observed in part A of the
study, at 42%, far exceeds the 10% threshold for success agreed
with our partner MSD for the cohort expansion phase, boding well
for the outcome of the ongoing Part B of the study. This is
ground-breaking for the microbiome in immuno-oncology. Considering
the advanced stage of disease of the patients in the study, end of
line patients who have previously failed on a checkpoint inhibitor
and have little to no remaining treatment options, these results
are very promising."
He added, "We believe that, while this is a small study, these
efficacy and safety results in such a difficult-to-treat population
are notable. To achieve these results while maintaining a very
clean safety profile is to our knowledge unparalleled, and
particularly significant in oncology where there is all too often
the unfortunate trade-off between treatment and quality of life,
and patients often elect to interrupt or stop treatment completely
due to adverse side effects."
Following successful completion of the Part A safety phase, the
Part B cohort expansion phase of the trial is enrolling at multiple
sites, and will assess the clinical benefit of the combination of
MRx0518 and KEYTRUDA in addition to safety, in up to 30 additional
patients per tumour type. The study is open-label and 4D pharma
expects to make periodic announcements on progress and updated
results as appropriate.
The trial is enrolling heavily pre-treated metastatic patients
with selected solid tumours refractory to ICIs. Eligible patients
must have experienced at least stable disease on previous ICI
therapy (as a monotherapy or combination) but eventually
progressed, as confirmed by two radiological scans >=4 weeks
apart in the absence of rapid clinical progression and within 12
weeks of last dose of ICI. Patients are treated with 1 capsule of
MRx0518 twice daily and pembrolizumab every 3 weeks for up to 35
cycles (approximately 2 years) or until disease progression. Tumour
response is assessed every 9 weeks per the RECIST 1.1 criteria. The
primary objective of Part B is to evaluate safety of the
combination. Secondary objectives were to evaluate efficacy via
overall response rate (ORR), duration of response (DOR), disease
control rate (DCR) and progression-free survival (PFS).
About MRx0518
MRx0518 is single strain Live Biotherapeutic product 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 patients who have previously progressed
on anti PD-1 therapies. The Coordinating Investigator of the study
is at The University of Texas MD Anderson Cancer Center, Houston,
USA, with multiple additional sites in the US. The study is being
conducted in collaboration with MSD, the tradename of Merck &
Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is in combination
with preoperative radiotherapy in resectable pancreatic cancer.
About MRx0518-I-002 clinical trial
MRx0518-I-002 (NCT03637803) is a Phase I/II open-label, safety
and preliminary efficacy study of MRx0518 in combination with
KEYTRUDA (pembrolizumab) in patients with solid tumours (non-small
cell lung cancer, renal cell carcinoma, bladder cancer or melanoma)
who have previously progressed on anti PD-1/PD-L1 therapy. Subjects
are treated with intravenous KEYTRUDA every three weeks and one
capsule twice daily of MRx0518. Treatment continues as long as
clinically relevant, until disease progression, unacceptable AEs or
withdrawal of consent up to a maximum of 35 cycles of KEYTRUDA.
Part A was conducted in 12 patients and Part B will be conducted
in up to 30 patients of each tumour type.
The Coordinating Investigator of the study is at The University
of Texas MD Anderson Cancer Center, Houston, USA, with multiple
additional sites in the US. The study is being conducted in
collaboration with MSD, the tradename of Merck & Co., Inc.,
Kenilworth, NJ, USA.
For more information on the trial, see
https://clinicaltrials.gov/ct2/show/NCT03637803
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(R), 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 six clinical studies in progress, namely a
Phase II clinical study of BLAUTIX(R) 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, a Phase I/II
study of MRx-4DP0004 in asthma, and a Phase II study of MRx-4DP0004
in patients hospitalised with COVID-19. Preclinical-stage programs
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 .
Contact Information:
4D
Duncan Peyton, Chief Executive Officer +44 (0)113 895 0130
Investor Relations ir@4dpharmaplc.com
N+1 Singer - Nominated Adviser and Joint Broker +44 (0)20 7496
3000
Aubrey Powell / Justin McKeegan / Iqra Amin (Corporate
Finance)
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332
2500
Dominic Wilson / Phil Walker
Image Box Communications
Neil Hunter / Michelle Boxall +44 (0)20 8943 4685
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