TIDMDDDD
4d Pharma PLC
22 June 2021
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4D pharma to Present at the Microbiome Movement Drug Development
Summit
Leeds, UK, June 22, 2021, - 4D pharma plc (AIM: DDDD, NASDAQ:
LBPS) , a pharmaceutical company leading the development of Live
Biotherapeutic products (LBPs) - a novel class of drug derived from
the microbiome, today announces Christophe Carite, Development
Director, will deliver a presentation on 4D pharma's strategy and
capabilities for the manufacturing of its Live Biotherapeutic drug
candidates at the upcoming virtual Microbiome Movement Drug
Development Summit, on Thursday, July 1 at 2.15pm EDT (7.15pm BST).
He will also participate in a microbiome therapeutics manufacturing
roundtable panel session.
The presentation will discuss 4D pharma's strategies,
technologies and facilities to address the challenges of
clinical-grade manufacturing and scale-up of its LBPs as a novel
therapeutic modality for the treatment of a range of indications
with unmet needs, including oncology, asthma, Parkinson's disease
and irritable bowel syndrome. The Company has successfully
conducted the manufacturing optimization and scale-up of multiple
novel LBPs at its in-house cGMP facility, and to date has
progressed four candidates into clinical trials with additional
candidates expected to enter the clinic in 2022.
In addition, Christophe Carite will join a panel entitled
'Effectively scaling up microbiome manufacturing'. This roundtable
will discuss the future of GMP infrastructure for microbiome
therapeutics, the most effective quality control processes and
potency methods, and the merits of developing internal
manufacturing facilities or using CDMO partners.
As 4D pharma has led the development of LBPs it has built
leading drug discovery and development expertise in this new field.
The Company has also developed unparalleled know-how, processes and
facilities for the manufacture of its LBPs to the highest
regulatory standards. 4D pharma has fully cGMP-certified facilities
in Europe, housing two 3,000L fermenters and downstream processing
facilities with production capacity sufficient for late clinical
and early commercial scale. Further, 4D pharma management were
previously invited to contribute to the drafting of the European
Pharmacopoeia's quality standards for Live Biotherapeutic products
which became effective in 2019.
"4D pharma's unique expertise in the efficient, scalable and
reproducible manufacturing of single strain LBPs has been
invaluable in supporting rapid clinical and pre-clinical progress
across our pipeline," said Christophe Carite, Development Director,
4D pharma. "Having these capabilities in-house not only supports
and accelerates progress, but also generates valuable know-how,
intellectual property and competitive advantage. As Live
Biotherapeutics near commercialization, manufacturing is
increasingly recognized as a critical factor in the future of this
novel drug class, and 4D pharma is well positioned to successfully
manage this important aspect of drug development in-house."
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 pharma's Live Biotherapeutic products (LBPs) are orally
delivered single strains of bacteria that are naturally found in
the healthy human gut. The Company has five clinical programs,
namely a Phase I/II study of MRx0518 in combination with KEYTRUDA
(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, a Phase I/II study
of MRx-4DP0004 in asthma (NCT03851250), and Blautix(R) in Irritable
Bowel Syndrome (IBS) (NCT03721107) 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 www.4dpharmaplc.com .
Contact Information:
4D pharma
Investor Relations: ir@4dpharmaplc.com
Investor Relations
Julie Seidel, Stern Investor Relations, Inc. +1-212-362-1200
Julie.seidel@sternir.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
neil@ibcomms.agency / michelle@ibcomms.agency
Forward-Looking Statements
This announcement contains "forward-looking statements." All
statements other than statements of historical fact contained in
this announcement, including without limitation statements
regarding timing of clinical trial commencement, LBP manufacturing,
production capacity and commercialization are forward-looking
statements within the meaning of Section 27A of the United States
Securities Act of 1933, as amended (the "Securities Act"), and
Section 21E of the United States Securities Exchange Act of 1934,
as amended (the "Exchange Act"). Forward-looking statements are
often identified by the words "believe," "expect," "anticipate,"
"plan," "intend, " "foresee," "should," "would," "could," "may,"
"estimate," "outlook" and similar expressions, including the
negative thereof. The absence of these words, however, does not
mean that the statements are not forward-looking. These
forward-looking statements are based on the Company's current
expectations, beliefs and assumptions concerning future
developments and business conditions and their potential effect on
the Company. While management believes that these forward-looking
statements are reasonable as and when made, there can be no
assurance that future developments affecting the Company will be
those that it anticipates.
All of the Company's forward-looking statements involve known
and unknown risks and uncertainties, some of which are significant
or beyond its control, and assumptions that could cause actual
results to differ materially from the Company's historical
experience and its present expectations or projections. The
foregoing factors and the other risks and uncertainties that affect
the Company's business, including the risks of delays in the timing
of clinical trial commencement, risks relating to the Company's
manufacturing facilities, and those additional risks and
uncertainties described the documents filed by the Company with the
US Securities and Exchange Commission ("SEC"), should be carefully
considered. The Company wishes to caution you not to place undue
reliance on any forward-looking statements, which speak only as of
the date hereof. The Company undertakes no obligation to publicly
update or revise any of its forward-looking statements after the
date they are made, whether as a result of new information, future
events or otherwise, except to the extent required by law.
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