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RNS Number : 0010N
4d Pharma PLC
27 May 2022
4D pharma Presents Trial in Progress Poster on the Phase II
Study of MRx0518 in Combination with BAVENCIO(R) in Patients with
Unresectable Locally Advanced or Metastatic Urothelial Carcinoma at
the 2022 American Society of Clinical Oncology (ASCO) Annual
Meeting
- Study to assess safety of MRx0518 with BAVENCIO and effect on
progression-free survival at 6 months
- Study sites are open for patient enrolment
Leeds, UK, May 27, 2022 - 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 announced the presentation of a trial in
progress poster from the Phase II clinical trial of MRx0518 in
combination with BAVENCIO(R) (avelumab), a PD-L1 blocking antibody,
as a first-line maintenance therapy for patients with unresectable
locally advanced or metastatic urothelial carcinoma that has not
progressed with first-line platinum-containing chemotherapy, at the
2022 American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago, IL.
"We are continuing to build a strong body of evidence to support
MRx0518 as a novel immunotherapy with broad potential to address
significant unmet need across multiple oncology indications," said
Dr Alex Stevenson, Chief Scientific Officer at 4D pharma. "MRx0518
has previously demonstrated single agent immuno-modulation of the
tumor microenvironment, and this data supports the potential of
this combination to significantly enhance and improve outcomes for
patients beyond treatment with BAVENCIO alone. Not only are we able
to evaluate MRx0518 with a leading immune checkpoint inhibitor, we
are also able to assess its potential in earlier treatment
settings. We are pleased to be sharing further details on the
design of our first-line maintenance study with BAVENCIO for the
treatment of locally advanced or metastatic urothelial carcinoma
with the oncology medical community at ASCO."
Poster Presentation Details:
Poster Title : Trial in progress: A phase II switch maintenance
study of live biotherapeutic MRx0518 and avelumab in patients with
unresectable locally advanced or metastatic urothelial carcinoma
(UC) who did not progress on first-line platinum-containing
chemotherapy
Presenting Author : Amishi Y. Shah MD, The University of Texas
MD Anderson Cancer Center, Houston, TX
Session Title : Genitourinary Cancer - Kidney and Bladder
Abstract Number : TPS4610
Poster Number : 95a
Date and Time : Saturday, June 4, 2022 at 13:15 CDT
Highlights from the trial in progress poster include:
-- The multi-center study (NCT05107427) will enroll 30 patients
with unresectable locally advanced or metastatic urothelial
carcinoma. Patients must have measurable disease after a partial
response (PR) or stable disease (SD) on 4-6 cycles of
platinum-containing induction chemotherapy.
-- Patients will receive intravenous BAVENCIO (avelumab) every
two weeks, in combination with one oral capsule of MRx0518 twice
daily, until disease progression, patient withdrawal, or
unacceptable toxicity.
-- In addition to assessing the safety of the combination of
MRx0518 with BAVENCIO, the study will assess the effect of the
combination on progression-free survival (PFS) at 6 months.
-- Secondary objectives are to assess other efficacy measures
including objective response rate (ORR), time to response, duration
of response (DOR), disease control rate (DCR), PFS, and overall
survival (OS).
-- Immunological changes of the microbiome and metabolome will
be assessed through biopsies, longitudinal blood sampling and stool
and urine samples.
-- The study is being conducted in collaboration with Merck
KGaA, Darmstadt, Germany and Pfizer Inc.
-- Study sites are open for patient enrolment.
The poster will be available on the "Posters & Publications"
section of the 4D pharma website at www.4dpharmaplc.com .
About MRx0518
MRx0518 is 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 four clinical trials in patients
with solid tumors. 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 patients with acquired resistance to
prior anti-PD-1/PD-L1 immune checkpoint 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. MRx0518-004 (AVENU) is a Phase II
clinical trial of MRx0518 in combination with BAVENCIO(R)
(avelumab) in the first-line maintenance setting for urothelial
carcinoma, conducted in collaboration with Merck KGaA, Darmstadt,
Germany and Pfizer Inc.
About 4D pharma
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 pharma 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 six clinical programs,
namely a Phase I/II study of MRx0518 in combination with
KEYTRUDA(R) (pembrolizumab) in solid tumors, a Phase II clinical
trial of MRx0518 in combination with BAVENCIO(R) (avelumab) in the
first-line maintenance setting for urothelial carcinoma , 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, and Blautix(R)
in irritable bowel syndrome (IBS) which has completed a successful
Phase II trial. A Phase I study of MRx0005 and MRx0029 in patients
with Parkinson's disease is expected to commence in 2022.
Additional preclinical-stage programs include candidates for CNS
disease, immune-inflammatory conditions and cancer. The Company has
a research collaboration with MSD (Merck & Co., Inc.,
Kenilworth, NJ, USA), to discover and develop Live Biotherapeutics
for vaccines.
Contact Information:
4D pharma
Investor Relations ir@4dpharmaplc.com
Singer Capital Markets - Nominated Adviser and Joint Broker
Philip Davies / James Fischer (Corporate Finance) +44 (0)20 7496
3000
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co. Limited - Joint Broker
Dominic Wilson +44 (0)20 7332 2500
Stern Investor Relations
Julie Seidel +1-212-362-1200
julie.seidel@sternir.com
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 the efficacy of Live Biotherapeutics including MRx0518,
and the ability of MRx0518 to modify the effects of immune
checkpoint inhibitors including avelumab, 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 present
expectations or projections. The foregoing factors and the other
risks that could cause actual results to differ materially include
risks relating to the efficacy of its Live Biotherapeutic drug
candidates including MRx0518, the risk that the Company changes its
expected strategy and plans, risk related to safety of
investigational therapeutics, clinical development risk, and those
additional risks and uncertainties described in the documents filed
by the Company with the US Securities and Exchange Commission
("SEC"). 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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