Enrollment progressing well for both expanded
Part B of MRx0518 and Keytruda® combination study, and pancreatic
cancer study
Further analysis of biomarker data in ongoing
MRx0518 neoadjuvant monotherapy study
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 progress on activities in its
development program for lead immuno-oncology single strain Live
Biotherapeutic candidate MRx0518.
“4D pharma has continued to
make excellent progress with the MRx0518 development program on
multiple fronts. We have generated additional safety and efficacy
data, building on the positive data from both the monotherapy and
KEYTRUDA combination studies last year. This clinical and
development progress has been achieved in spite of the headwinds of
COVID-19,” said Dr. Alex
Stevenson, Chief Scientific Officer, 4D pharma. “As 4D pharma
extends its leading position in this exciting and rapidly maturing
field, we see the next 12 months as being instrumental for the
space. We look forward to generating more clinical data from our
ongoing studies of MRx0518 in multiple different tumor types and
treatment settings. This will support 4D pharma’s continued
productive engagement with regulatory authorities to develop the
clinical strategy to bring this novel therapeutic to patients
suffering from a range of cancers.”
MRx0518 in Combination with KEYTRUDA
MRx0518 is in an ongoing Phase
I/II clinical trial in combination with immune checkpoint inhibitor
(ICI) Keytruda® (pembrolizumab), MSD’s anti-PD-1 therapy, in
patients with advanced malignancies who have previously progressed
on ICI therapy. This study is comprised of two parts - Part A, an
initial safety phase assessing dose-limiting toxicities of the
combination, and the Part B cohort expansion phase to assess
clinical benefit in addition to safety. In May 2020 the successful
completion of Part A and initiation of Part B was
announced.
24 additional patients across
five active US sites have now been treated in Part B of this
ongoing study. The safety review following the first Part B cohort
of 10 renal cell carcinoma (RCC) patients has been completed
indicating no dose limiting toxicities. A total of 12 patients with
RCC, nine patients with non-small cell lung cancer (NSCLC) and
three bladder cancer patients have been enrolled in Part B to date.
Recruitment will continue up to a total of 30 patients in each of
these indications.
Target tumor reductions in
Part B patients have been observed as patients reach the first
scheduled restaging timepoint (nine weeks). These include the first
signals of anti-tumor activity for the combination in bladder
cancer, adding to the previously reported activity in RCC and NSCLC
in patients in Part A.
Three Part A patients with RCC
and NSCLC that were previously reported to have experienced
clinical benefit continue on the study. Two of these patients have
now been treated for over 18 months and have had further target
tumor reductions or extended disease control since the last update.
Efficacy of the combination continues to be evaluated on an ongoing
basis.
Following the positive results
of Part A in RCC and NSCLC, the new tumor cohorts added to Part B
of the study are now open to recruitment. Patients with advanced
malignancies resistant to ICI therapy, including triple-negative
breast cancer, head and neck squamous cell carcinoma and
microsatellite instability-high/mismatch repair deficient cancers,
are now eligible for inclusion. Enrolment for the trial is expected
to complete in Q4 2021.
MRx0518 with Radiation in Pancreatic Cancer
Five patients are now enrolled
in this Phase I trial. The study is designed to evaluate safety and
efficacy in 15 patients receiving treatment with MRx0518 and
hypofractionated radiation prior to surgery for pancreatic cancer.
This study will generate valuable data to assess the relationship
between systemic and tumor biomarkers, as well as clinical
outcomes. Study treatment is well tolerated to date. Enrolment
continues and we anticipate receiving initial data from this
clinical trial in 2021.
MRx0518 in Neoadjuvant Setting Monotherapy
The previously reported 17
patients in the completed Part A of this Phase I study continue in
the follow up phase for survival outcomes. Biomarker and safety
data from the study were presented at the Society for Immunotherapy
of Cancer (SITC) Annual Meeting 2020, demonstrating systemic immune
and tumor microenvironment modulation following two to four weeks
of treatment with MRx0518. Additional biomarker analyses are
underway to further investigate the immune response induced by
MRx0518. These additional results may inform an optimization of
Part B of this study.
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 (NCT03934827) is
a neoadjuvant monotherapy study in a variety of solid tumors and is
being conducted at Imperial College (London, UK). MRx0518-I-002
(NCT03637803) 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 (NCT04193904) 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®, 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
(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), a Phase II study of
MRx-4DP0004 in patients hospitalized with COVID-19 (NCT04363372),
and Blautix® 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.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210203005075/en/
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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