TIDMDDDD
4d Pharma PLC
14 October 2020
4D pharma announces three presentations at The Society for
Immunotherapy of Cancer (SITC) Annual Meeting 2020
Initial immune modulation and safety data from MRx0518
neoadjuvant monotherapy trial in patients awaiting surgical
resection of solid tumors
Update on safety and efficacy results of Part A of combination
trial of MRx0518 and Keytruda(R) in patients refractory to immune
checkpoint inhibitors
Further information on ongoing Part B cohort expansion phase of
MRx0518 and Keytruda(R) combination trial
Leeds, UK - October 14, 2020 - 4D pharma plc (AIM: DDDD), a
pharmaceutical company leading the development of Live
Biotherapeutics, today announces the acceptance of multiple
presentations at the Society for Immunotherapy of Cancer (SITC)
35th Annual Meeting, November 9-14, 2020. The three posters will
focus on two of 4D pharma's clinical trials of lead immuno-oncology
single strain Live Biotherapeutic MRx0518.
The first poster will describe initial immune modulation and
safety data from the MRx0518 neoadjuvant monotherapy trial in
patients awaiting surgical resection of solid tumors.
Two further posters will provide details of the MRx0518 and
Keytruda(R) (pembrolizumab) combination study in patients who are
refractory to immune checkpoint inhibitors. One will provide an
additional update on safety and clinical efficacy in patients from
the concluded Part A of the study. The second will provide
information on the ongoing cohort expansion phase of the trial,
Part B.
"4D pharma is building significant amounts of clinical oncology
data that demonstrate the potential of single strain Live
Biotherapeutics as treatments for a range of solid tumors,
including refractory patients with no alternative treatment
options. It is critical for us to share this ground-breaking data
at events like SITC to continue to push this exciting field
forward," said Dr. Alex Stevenson, Chief Scientific Officer of 4D
pharma. "For the first time, we will be reporting initial immune
modulation and safety data from 4D pharma's study of the MRx0518 as
a neoadjuvant monotherapy. This data could be particularly
important in developing our understanding of the mechanism of
action of MRx0518 in the clinical setting, a key component of
maximising its potential as a novel immuno-oncology therapeutic. In
addition, having reported initial proof-of-concept for the MRx0518
and Keytruda combination study earlier this year, SITC provides the
ideal platform to provide an update on progress with this
study."
SITC 2020 Poster Presentation Details:
Safety and emerging evidence of immune modulation of the live
biotherapeutic MRx0518 in the neoadjuvant setting for patients
awaiting surgical removal of solid tumors
Abstract Number: 805
Presented: 11-14 Nov Virtual Poster Hall
Q&A Session: 11 Nov 5:15-5:45pm EST & 13 Nov 4:40-5:10pm
EST
A phase I/II study of live biotherapeutic MRx0518 in combination
with pembrolizumab in patients refractory to immune checkpoint
inhibitors
Abstract Number: 710
Presented: 11-14 Nov Virtual Poster Hall
Q&A Session: 12 Nov 4:50-5:20pm EST & 14 Nov 1-1:30pm
EST
Safety and efficacy signals in the complete phase I study of
live biotherapeutic MRx0518 in combination with pembrolizumab in
patients refractory to immune checkpoint inhibitors (ICIs)
Abstract Number: 609
Presented: 11-14 Nov Virtual Poster Hall
Q&A Session: 11 Nov 5:15-5:45pm EST & 13 Nov 4:40-5:10pm
EST
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 4D pharma
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 programmes, namely 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, a Phase II study of MRx-4DP0004 in patients hospitalised
with COVID-19, and Blautix(R) in Irritable Bowel Syndrome (IBS)
which has completed a successful Phase II trial. 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
Philip Davies / 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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