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4d Pharma PLC
17 March 2020
PRESS RELEASE:
4D pharma presents additional interim clinical data from
combination study for lead oncology candidate
First global clinical confirmation of a live biotherapeutic
product (LBP) initiating a response in cancer patients
Leeds, UK, March 17, 2020 - 4D pharma plc (AIM: DDDD), a
pharmaceutical company leading the development of Live
Biotherapeutics, today announces an update on the previously
reported interim data from an ongoing phase I/II clinical trial, in
collaboration with MSD, a tradename of Merck & Co., Inc.,
Kenilworth, NJ, USA, to evaluate 4D pharma's lead oncology
candidate, MRx0518, in combination with MSD's anti-PD-1 therapy
KEYTRUDA (R) (pembrolizumab), in patients with advanced
malignancies who have previously responded and whose disease has
then progressed on PD-1/PD-L1 inhibitors.
The additional data has been presented to delegates of Chardan's
virtual 2nd Annual Microbiome Medicines Summit, on March 16, 2020.
The data was presented by Duncan Peyton, CEO and Alex Stevenson,
CSO, 4D pharma. The presentation provides additional detail on
headline interim results from the phase I/II clinical trial
announced on November 6, 2019. The trial is being conducted, and
data compiled at MD Anderson, University of Texas, US.
The data is the first global clinical confirmation of a live
biotherapeutic product (LBP) initiating a response in cancer
patients. The patients in the live biotherapeutic clinical trial
had all previously received multiple lines of treatment with little
efficacy, exhausting all currently approved treatment options. 4D
pharma believes that the data provide evidence that adding the
Company's product, MRx0518, to the checkpoint inhibitor treatment
regimen can induce tumour responses in patients who have previously
become refractory to these therapies. 4D believes that, if
demonstrated in larger studies, the addition of MRx0518 to
checkpoint therapy will enable approved checkpoint inhibitors to
work more effectively, for a longer duration, and in a wider
patient population.
The phase I/II 4D pharma study is an open label trial to
evaluate the safety and preliminary efficacy of MRx0518 and
KEYTRUDA (R) in patients with renal cell carcinoma (RCC), melanoma,
non-small cell lung cancer (NSCLC) and bladder cancer, who have
developed resistance to PD-1/PD-L1 inhibitors. Checkpoint
therapies, whilst capable of producing durable anti-tumour
responses, are not effective in all patients. In addition, those
who do respond can develop resistance over time, leading to disease
progression. The study has been designed to investigate this effect
in patients with advanced metastatic disease.
C linical observations from the first six patients in part A
were presented, including:
-- Two partial responses (PR) with evidence of tumor shrinkage
who remain on study (one patient for over 10 months)
-- One patient with stable disease (SD), remains on study for over eight months
-- Evidence of increased tumor-infiltrating lymphocytes (TILs) following treatment
-- No drug related serious adverse events
Specifically, one stage IV NSCLC patient had received seven
lines of therapy over nearly three years with little response. In
this patient the combination of MRx0518 + KEYTRUDA (R) achieved an
overall 51% reduction in target tumors at last assessment. The
patient has now been on drug for 41 weeks.
"The further interim data from the Phase I/II trial provide
significant potential for fresh treatment options for oncology
patients that have exhausted all other currently approved
therapies," said Duncan Peyton, CEO, 4D pharma. 4D pharma is now
delivering the first global clinical evidence of the therapeutic
potential of oral live biotherapeutics in cancer. This confirms the
significant impact of microbiome immuno-oncology to the
pharmaceutical industry in providing additional treatments for
patients with underserved needs and little available therapeutic
options. This clinical validation of live biotherapeutics to impact
diseases external to the gut significantly supports our wider
clinical pipeline in other areas such as neurodegeneration and
other cancers."
Recruitment for the trial continues to progress as expected,
with recruitment for Part A now completed. 4D expects to announce
data for all 12 Part A subjects in Q2 and to commence enrolment for
Part B, which will expand the study based on the Part A data. It is
expected that the study will be expanded to additional
international trial locations and sites, initially in the US. 4D
pharma also expects to discuss the findings from Part A and avenues
for accelerated development with the regulatory agencies.
[Ends]
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 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 and a
Phase I/II study of MRx-4DP0004 in asthma. Preclinical-stage
programmes 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 .
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 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 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.
Contact Information:
Image Box PR
Neil Hunter / Michelle Boxall
Tel +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency
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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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