TIDMDDDD
RNS Number : 3688M
4d Pharma PLC
11 May 2020
4D pharma plc
(the "Company" or "4D")
Successful completion of immuno-oncology study safety phase
Leeds, UK, 4D pharma plc (AIM: DDDD), a pharmaceutical company
leading the development of Live Biotherapeutics, today announces
successful completion of Part A of a Phase I/II clinical trial of
MRx0518 in combination with immune checkpoint inhibitor Keytruda(R)
(pembrolizumab). Part A of the study evaluated the therapeutic
combination in patients with advanced solid tumors who had
previously shown an initial clinical benefit to PD-1/PD-L1 immune
checkpoint inhibitors, but had subsequently developed secondary
resistance and progressive disease.
The safety review committee for the study has evaluated data
collected during the Dose Limiting Toxicity (DLT) period of the
trial, the first cycle of treatment for the first 12 patients. The
committee determined that it is safe to proceed to Part B of the
study. Part B of the study has now commenced and will assess
clinical benefit and safety, enrolling up to an additional 30
patients per tumor type cohort (up to a total of 120). Enrolment
will be expanded to additional trial locations and sites. The study
is open label and an update on progress is anticipated later in the
year.
Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma,
commented:
"As with all of 4D pharma's Live Biotherapeutics targeting a
range of conditions, a good safety profile for MRx0518 was
expected. It is important that this has been confirmed in Part A of
this study in combination with a PD-1 immune checkpoint
inhibitor.
"Commencing Part B of the study and expanding enrolment will
enable us to build on the very encouraging preliminary signals of
efficacy we have seen. These initial results indicate the potential
for MRx0518 to be a game-changing immunotherapy for this
particularly difficult-to-treat patient population for which all
other therapeutic options have been exhausted."
Dr. Jean-Pierre Bizzari, chair of the New Drug Advisory
committee of the EORTC(1) , and formerly Executive Vice-President
and Head of Clinical Oncology Development at Celgene,
commented:
"The data from Part A of the study are very encouraging and
quite promising, with the drug combination exhibiting an excellent
safety profile and early signs of clinical benefit in heavily
pre-treated patients with advanced metastatic disease. Further
studies are warranted and I look forward to working with 4D in
evaluating this treatment in a larger population of patients in
Part B of the study".
4D pharma previously reported positive interim clinical
observations from Part A, in which three of the first six patients
enrolled achieved a clinical benefit (complete response, partial
response, or stable disease for six months or more), evidence of
increased tumor-infiltrating lymphocytes (TILs) following
treatment, and no drug related serious adverse events. These
patients continue to show clinical benefit and have now been on
study for between nine and twelve months. Further details on these
patients, including treatment histories and the magnitude of
responses, were presented at Chardan's 2(nd) Annual Microbiome
Medicines Summit in March ( www.4dpharmaplc.com ).
1 The European Organsiation for Research and Treatment of Cancer
About MRx0518
MRx0518, a product of 4D's discovery platform MicroRx(R), is a
single strain Live Biotherapeutic Product (LBP) 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 tumors.
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 tumors and is being conducted at Imperial
College (London, UK). MRx0518-I-002 is in combination with
KEYTRUDA(R) (pembrolizumab) in collaboration with MSD, a tradename
of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is a
study in combination with radiotherapy in patients with 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 tumors
(non-small cell lung cancer, renal cell carcinoma, bladder cancer
or melanoma) who have previously shown initial clinical benefit on
anti PD-1/PD-L1 therapy, but subsequently developed progressive
disease 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 (of any of the four tumor
types) and Part B will be conducted in up to 30 patients of each
tumor type, giving an overall total of up to 132 patients.
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.
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 five 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 tumors, a Phase I study of
MRx0518 in a neoadjuvant setting for patients with solid tumors, a
Phase I study of MRx0518 in patients with pancreatic cancer and a
Phase I/II study of MRx-4DP0004 in asthma. 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 / Alex Bond (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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