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RNS Number : 0523S
4d Pharma PLC
06 July 2020
4D pharma plc
(the "Company" or "4D")
4D pharma treats first cancer patients in Part B of Phase I/II
trial of MRx0518 in combination with Keytruda(R)
Leeds, UK, 6 July, 2020 - 4D pharma plc (AIM: DDDD), a
pharmaceutical company leading the development of Live
Biotherapeutics, today announces it has commenced treatment of the
first patients in Part B of its Phase I/II clinical trial of
MRx0518 in combination with immune checkpoint inhibitor Keytruda(R)
(pembrolizumab) in patients with acquired resistance to prior
immune checkpoint therapy.
Part B of the Phase I/II study will evaluate clinical benefit of
MRx0518 and Keytruda(R), defined as a complete response or partial
response or stable disease for six months or longer. Safety and
tolerability will also be evaluated. Part B of the study will
assess up to an additional 30 patients per tumour type cohort.
To rapidly build on the proof of concept data previously
reported from Part A of the study, 4D pharma is opening four
additional trial sites in the US throughout July and August to
support accelerated patient recruitment for Part B of the trial.
The study is open label and an interim update is anticipated later
in the year.
The Part A safety phase of the study has been successfully
completed, as reported in May 2020. In Part A there were no
treatment-related serious adverse events, no treatment-related drug
discontinuations and no increase of immune-related adverse events
as seen with immune checkpoint inhibitors. Of the 12 patients
enrolled in Part A, five remain on study including two patients
with best response of partial response, one patient with ongoing
stable disease for over six months, and two patients with ongoing
stable disease currently for less than six months. These represent
first-in-class proof of concept clinical data for a Live
Biotherapeutic in cancer.
Duncan Peyton, CEO, 4D pharma, commented "Immune checkpoint
inhibitor therapies have provided a significant step forward in the
toolbox in the fight against cancer. Unfortunately however, they do
not work in all patients, and in those patients that do benefit
that response can be lost over time. This results in a substantial
group of patients who are extremely ill and, due to the stage of
their disease and failure of previous lines of therapy, have no
approved treatment options. Part A of our trial demonstrated that
4D pharma's candidate MRx0518 may provide benefit to this group of
patients. Commencing Part B of the study and opening new sites in
the US to accelerate recruitment will allow us to build quickly on
the positive results of Part A. Continued positive results will
support MRx0518 as a much needed novel therapeutic for patients who
currently have no alternative treatment options . This is another
important step towards our aim to have the first approved Live
Biotherapeutic in an oncology setting ."
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(R) (pembrolizumab) in patients who have previously
progressed on anti PD-1 therapies. This study is being carried out
at The University of Texas MD Anderson Cancer Center, Houston, USA,
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(R) (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(R) 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.
This study is being carried out at The University of Texas MD
Anderson Cancer Center, Houston, USA, in collaboration with MSD,
the tradename of Merck & Co., Inc., Kenilworth, NJ, USA.
Additional US sites are being opened to supported accelerated
enrolment.
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(R) (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 PR
Neil Hunter / Michelle Boxall +44 (0)20 8943 4685
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END
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