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RNS Number : 8766F
4d Pharma PLC
10 November 2022
4D pharma Announces Two Presentations at The Society for
Immunotherapy of Cancer Annual Meeting (SITC 2022)
Leeds, UK - November 10, 2022 - 4D pharma plc (AIM: DDDD) (in
administration), a pharmaceutical company leading the development
of Live Biotherapeutic products (LBPs), a novel class of drug
derived from the microbiome, today presented new biomarker data
from two ongoing clinical trials of its lead immuno-oncology single
strain Live Biotherapeutic, MRx0518, at the at the Society for
Immunotherapy of Cancer's (SITC) 37th Annual Meeting (SITC 2022),
held from November 8-12, 2022. The two e-posters are available via
the 4D pharma website at https://www.4dpharmaplc.com .
"The two posters presented at the prestigious SITC 2022 event
demonstrate 4D pharma's commitment and leadership in understanding
the mechanisms of action of its Live Biotherapeutic Products," said
Dr. Alex Stevenson, Chief Scientific Officer at 4D pharma.
"Building on previously published clinical and biomarker results,
with this new data we show how MRx0518 is able to drive meaningful
clinical benefit for patients by acting on both the human immune
system to overcome immunosuppression for better outcomes with
immune checkpoint inhibitor therapy, and the microbiome"
One poster presentation highlights the suppressed immune state
of patients who have acquired resistance to prior anti-PD-1/PD-L1
immune checkpoint inhibitors, at baseline compared to controls.
Following treatment with the combination of MRx0518 and KEYTRUDA(R)
(pembrolizumab), there is an increased expression of the activation
markers HLA-DR and CD86, and a trend in reduction of myeloid cells
expressing the immune checkpoint PD-L1, in responders but not
non-responders. The results also identify a significant increase in
circulating CD8+ T cells after treatment with the combination, in
responders but not in non-responders, an immune population well
known to correlate with better outcomes for immune checkpoint
inhibitor treatment.
A second poster presents the first clinical microbiome and
metabolome modulation data for MRx0518, building on previously
reported immunomodulatory data from the same study. Following
neoadjuvant treatment with MRx0518 monotherapy, there is a
significant increase in the presence of MRx0518 in stool samples
which then returns to baseline levels. This data supports 4D
pharma's thesis regarding the viability and pharmacokinetics of
safe and effective transient colonization of its orally
administered Live Biotherapeutics in the human gastrointestinal
tract. In addition, the results demonstrate treatment with the
single strain LBP MRx0518 is associated with significant shifts in
gut microbiome composition and significant increases in short-chain
fatty acid metabolites that may contribute to the anti-tumorigenic
efficacy demonstrated by MRx0518
Poster presentation details are as follows:
Presentation Title: Combination of MRx0518 and anti-PD-1
overcomes checkpoint inhibitor resistance via myeloid
modulation
Presenting Author: Dr. June Li, Research Scientist, Department
of Translational Molecular Pathology, The University of Texas MD
Anderson Cancer Center
Abstract Number: 838
Presentation Title: Oral administration of MRx0518 in
treatment-naïve cancer patients is associated with compositional
taxonomic and metabolomic changes indicative of anti-tumorigenic
efficacy
Presenting Author: Dr. Mark P. Lythgoe, Academic Clinical Fellow
in Medical Oncology and Pharmacist, Imperial College London
Abstract Number: 627
On 24 June 2022, David Pike and James Clark of Interpath
Advisory were appointed as administrators of 4D pharma plc. The
administrators have had no oversight of or involvement in the
preparation of the SITC 2022 poster presentations nor in any
materials which will be circulated in advance of or during SITC
2022. Therefore, the administrators make no statement or
representation in respect of the materials shared or discussed in
advance of or during SITC 2022.
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 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
(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. A
fourth clinical trial is planned, in collaboration with Merck KGaA
and Pfizer Inc., of BAVENCIO (avelumab) in combination with MRx0518
as a first-line maintenance therapy for patients with locally
advanced or metastatic urothelial carcinoma that has not progressed
with first-line platinum-containing chemotherapy.
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 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, 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 pharma
4dpharma@interpathadvisory.com
Singer Capital Markets - Nominated Adviser and Joint Broker
Philip Davies / James Fischer (Corporate Finance) +44 (0)20 7496
3000
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