TIDMDDDD
RNS Number : 6766E
4d Pharma PLC
09 November 2020
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4D Pharma Presents New Data from Two MRx0518 Clinical Trials
at the Society for Immunotherapy of Cancer (SITC) Annual
Meeting
MRx0518 demonstrates upregulation of key immune biomarkers
associated with anti-cancer activity in neoadjuvant monotherapy
setting
Addition of new tumor type cohorts to ongoing Part B of Phase
I/II combination trial with pembrolizumab, following 42% disease
control rate (DCR) in completed Part A
Company to host virtual KOL event to review data on
Wednesday, November 11, 2020 at 1:00pm GMT (8:00am ET)
LEEDS, England--(BUSINESS WIRE)--4D pharma plc (AIM: DDDD), a
pharmaceutical company leading the development of Live
Biotherapeutic products (LBPs) - a novel class of drug derived from
the microbiome, today announces new positive clinical data from two
clinical trials of MRx0518, its lead immuno-oncology single strain
Live Biotherapeutic candidate. The data is presented in three
posters at the Society for Immunotherapy of Cancer (SITC) Annual
Meeting 2020, November 9-14, 2020.
-- The first poster includes the first data presented for
MRx0518 as a monotherapy. The results are from the completed Part A
of a Phase I trial of MRx0518 in the neoadjuvant setting.
-- Two further presentations provide updates on the ongoing
Phase I/II trial of MRx0518 in combination with Keytruda(R)
(pembrolizumab) in patients refractory to checkpoint
inhibitors.
-- 4D pharma will also host a virtual key opinion leader (KOL)
event to review these data on Wednesday, November 11, 2020 at
1:00pm GMT (8:00am ET).
"The data generated from both our trials of MRx0518 and
presented this week at SITC, in monotherapy and combination with an
immune checkpoint inhibitor settings, is further evidence of the
potential of 4D's LBPs in oncology. The strong immunological
signals of biological activity shown in the monotherapy trial
provides further clinical evidence of the role and contribution of
MRx0518 to the impressive results we are seeing in combination with
Keytruda in an incredibly difficult to treat patient population,"
said Duncan Peyton, Chief Executive Officer of 4D pharma. "The data
also furthers and clarifies our earlier work on the mechanism of
action of MRx0518 and, importantly, the activity we are seeing in
these patients mirrors the preclinical results, further validating
our approach and the MicroRx platform. The data generated from
these trials provide us with huge confidence not only with moving
forward with MRx0518 as a novel immunotherapy for the treatment of
cancer, but also our MicroRx platform. We look forward to advancing
our MRx0518 program further into the clinic and we are already
enrolling patients into Part B of our Keytruda combination study,
including the addition of new tumor type cohorts."
MRx0518 in Neoadjuvant Setting Monotherapy
The ongoing, two-part Phase I study is assessing the safety and
tolerability of MRx0518 monotherapy in treatment-naïve subjects
undergoing surgical resection of solid tumors. The study is
designed to generate paired patient samples at diagnostic biopsy
and surgical resection, with an intervening period of MRx0518
monotherapy treatment of two to four weeks.
As of data cut-off at October 10, 2020, 17 patients were
evaluable for safety and biomarker analyses.
Immune Modulation Results
-- Following MRx0518 treatment, relative increases in cytotoxic
cells, CD8+ T cells and other immune subsets associated with
anti-tumor activity were observed in paired tumor samples.
-- Upregulation of key immuno-stimulatory anti-tumor cytokines
and chemokines, such as IL-12 and CXCL10, was observed in
post-treatment plasma samples.
Genomic Modulation Results
-- Gene expression analysis identified significant expression
changes in 98 genes (p<0.05) in paired samples as a result of
MRx0518 treatment, including upregulation of pathways associated
with antigen presentation, costimulatory signaling, cytokine and
chemokine signaling, known to promote anti-tumor immune activity
.
Initial Safety Data
-- MRx0518 monotherapy was generally well-tolerated with no SAEs
or grades 3 or 4 toxicities reported.
MRx0518 in Combination with Pembrolizumab - Part A Safety and
Efficacy data
The ongoing Phase I/II open-label, two-part clinical trial is
evaluating the safety and preliminary efficacy of MRx0518 in
combination with pembrolizumab in heavily pre-treated metastatic
patients with solid tumors refractory to immune checkpoint
inhibitors.
The goal of the Part A phase of this study was to assess the
safety, tolerability and initial efficacy enrolled a total of 12
heavily pre-treated metastatic renal cell carcinoma (RCC) and
non-small cell lung cancer (NSCLC) patients refractory to immune
checkpoint inhibitors. All patients received a twice daily dose of
oral MRx0518 for 3 weeks in combination with a single cycle of
pembrolizumab, and assessed for dose-limiting toxicities. Once the
treatment cycle was completed, patients were eligible to remain on
treatment for up to 2 years to assess clinical benefit.
As of the data cut-off date October 23, 2020, all 12 patients
enrolled in Part A of this study were evaluable for safety and
preliminary efficacy.
Initial Clinical Activity Data
-- MRx0518 in combination with pembrolizumab provided clinical
benefit to 5 of 12 (42%) patients, defined as a complete response
(CR), partial response (PR) or stable disease (SD) for 6 months or
longer.
-- Of the 5 patients who achieved clinical benefit, 3 patients
experienced PR, an overall response rate (ORR) of 25%. Best overall
response to prior to immune checkpoint inhibitor treatment for 2 of
these patients was stable disease (SD).
-- Median progression free survival (PFS) was 2.14 (95% CI 0.43, not estimable) months.
Initial Safety Data
-- MRx0518 in combination with pembrolizumab was generally
well-tolerated with no treatment-related Grades 4 or 5 serious
adverse events (SAEs) reported.
-- No treatment-related adverse events were attributed to treatment discontinuation.
MRx0518 in Combination with Pembrolizumab - Part B Ongoing,
Addition of New Cohorts
In addition to the new safety and preliminary efficacy data
announced today, 4D also presented a trial-in-progress (TIP) poster
describing the ongoing Part B cohort expansion phase of the Phase
I/II clinical trial of MRx0518 in combination with pembrolizumab in
patients refractory to immune checkpoint inhibitors. Today 4D
pharma announced additional tumor type cohorts will be enrolled on
the study, following the promising clinical benefit results
generated in Part A in patients with RCC and NSCLC.
Part B of this study is currently enrolling up to 120 patients
with RCC, NSCLC, bladder cancer, triple-negative breast cancer
(TNBC), head and neck squamous cell carcinoma (HNSCC) and
microsatellite instability-high/mismatch repair deficient
(MSI-H/dMMR) solid tumors. Enrollment is expected to complete Q4
2021.
The clinical data from the two MRx0518 clinical trials presented
at the SITC Annual Meeting are now available on the Posters and
Publications section of the 4D Pharma website at
www.4Dpharmaplc.com .
For more information on the clinical trials see
https://clinicaltrials.gov/ct2/show/NCT03934827 and
https://clinicaltrials.gov/ct2/show/NCT03637803
Virtual KOL Conference Call and Webcast Event
4D pharma will host a virtual event for investors and analysts
to review the data presented from two ongoing clinical trials of
MRx0518 at SITC 2020. The event will take place on Wednesday,
November 11, 2020 at 1:00pm GMT (8:00am ET) and will feature
discussions of data from both trials from Dr. Mark P. Lythgoe,
Academic Clinical Fellow in Medical Oncology and Pharmacist at
Imperial College London, and Dr. Shubham Pant, Associate Professor
Department of Investigational Cancer Therapeutics and Department of
Gastrointestinal Medical Oncology at the University of Texas MD
Anderson Cancer Center, as well as presentations from 4D
management.
A live webcast of the event will be available on the Reports and
Presentations section of the 4D pharma website at
www.4Dpharmaplc.com . To access the call, please dial
1-877-270-2148 (United States) or 1-412-902-6510 (international)
and reference the 4D pharma conference call to join. A replay of
the webcast and accompanying slides will be available on the 4D
pharma website following the event.
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 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 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 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.
In October 2020 4D Pharma announced its intention to merge with
Longevity Acquisition Corporation (NASDAQ: LOAC), a special purpose
acquisition company (SPAC), and seek a NASDAQ listing. The merger
is expected to be completed and the NASDAQ listing of 4D Pharma
American Depositary Shares (ADSs) under the ticker symbol 'LBPS' is
currently expected to become effective in early 2021, subject to
approval of 4D shareholders and Longevity shareholders, and the SEC
review process.
For more information, refer to https://www.4dpharmaplc.com .
Contact Information:
4D Pharma
Duncan Peyton, Chief Executive Officer +44 (0)113 895 0130
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
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