TIDMDDDD
RNS Number : 0907P
4d Pharma PLC
05 June 2020
4D pharma plc
(the "Company" or "4D")
4D hosts virtual R&D event providing updates on clinical
programmes in oncology and COVID-19
Leeds, UK, 4D pharma plc (AIM: DDDD), a pharmaceutical company
leading the development of Live Biotherapeutics, today announces a
virtual R&D event in which Duncan Peyton, Chief Executive
Officer, 4D pharma, Prof. Axel Glasmacher, Chairman, 4D pharma, and
Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma, provide
updates on the company's clinical programmes in oncology and
COVID-19. Covering analysts were invited to participated in a
Question & Answer session after the presentation. The
presentation slides and a recording are accessible via the "Reports
and Presentations" area of 4D's website at
https://www.4dpharmaplc.com .
Clinical update summary: oncology and COVID-19 programmes
Oncology
-- Early data supports proof of concept in metastatic renal cell
carcinoma, with potential to expand into additional tumour
types
-- Continuing positive signals further validate the Company's
single strain Live Biotherapeutic approach
-- Further clinical confirmation of expected favorable safety
profile of therapeutics developed by the Company
COVID-19
-- MRx-4DP0004 has a relevant mechanism of action for COVID-19
-- Research Ethics Committee and Health Research Authority approval received
-- Clinical site selection and initiations underway
-- First patient dosing expected June 2020
Oncology - MRx0518 and Keytruda(R) Phase I/II Combination
Study
The presentation provides additional efficacy results from the
ongoing Phase I/II trial of immuno-oncology candidate MRx0518 in
combination with Keytruda(R) in solid tumours. Of the twelve
patients who were enrolled in Part A, five are continuing on study
treatment.
Two of these five patients had tumours that achieved a partial
response (PR). One is a patient with metastatic renal cell
carcinoma (mRCC), who has now been on the study for over a year and
has received three previous lines of therapy before enrolling on
the study. The other is a patient with metastatic non-small cell
lung cancer (mNSCLC) with a mutation in Epidermal Growth Factor
Receptor (EGFR). This patient has been on the study for 49 weeks
and has had seven previous lines of therapy. NSCLC patients
harboring EGFR mutations are reported to be less likely to show
clinical benefit from PD-1/PD-L1 checkpoint inhibitors.(1, 2,
3)
Both of these patients' tumours showing partial responses to the
combination of MRx0518 and Keytruda(R) combined with a PD-1
checkpoint inhibitor had previously shown a response no better than
stable disease (SD) to PD-1 checkpoint inhibitor treatment, before
developing secondary resistance and progressive disease.
Three further patients taking part in the study have mRCC and
have exhibited stable disease (SD). One has been on the study for
44 weeks, one for 15 weeks and the other for 12 weeks.
Seven of the twelve patients who were enrolled in Part A have
been withdrawn from treatment. Two patients were withdrawn due to
progressive disease determined at the first scheduled restaging
scan at nine weeks. Three patients were withdrawn following
disease-related serious adverse events (SAE) and an early first
restaging scan. Two patients were withdrawn prior to any restaging
scan due to SAEs related to disease progression.
Part B of the study is now open to recruitment of an additional
30 patients per tumour type cohort included in the study. Four
additional investigational sites will be opened.
COVID-19 - Phase II Clinical Study
In April, 4D pharma announced receipt of expedited clinical
trial authorization (CTA) from the UK's Medicines and Healthcare
products Regulatory Agency (MHRA) for a Phase II randomized,
double-blind, placebo-controlled study in up to 90 patients
hospitalized with COVID-19.
The study has now received Research Ethics Committee and Health
Research Authority approvals and the Company is in the process of
initiating the first clinical sites, with the first subjects
expected to be recruited in June. Preliminary data is expected in
Q4 2020.
Further summary information on the clinical programmes discussed
during the webinar is included below.
1. Lee CK, Man J, Lord S. et al. Clinical and molecular
characteristics associated with survival among patients treated
with checkpoint inhibitors for advanced non-small cell lung
carcinoma: a systematic review and meta-analysis. JAMA Oncol 2018;
4(2): 210-216. doi:10.1001/jamaoncol.2017.4427
2. Lisberg A, Cummings A, Goldman JW. et al. A phase II study of
pembrolizumab in EGFR-mutant, PD-L1+, tyrosine kinase inhibitor
(TKI) naive patients with advanced NSCLC. J Thorac Oncol 2018;
13(8): 1138-1145 . doi: 10.1016/j.jtho.2018.03.035
3. Borghaei H, Paz-Ares L, Horn L. et al. Nivolumab versus
docetaxel in advanced nonsquamous non-small-cell lung cancer. N
Engl J Med 2015; 373(17): 1627-1639. doi: 10.1056/NEJMoa1507643
Contact Information:
4D
Duncan Peyton, Chief Executive Officer +44 (0)113 895 0130
Investor Relations ir@4dpharmaplc.com
N+1 Singer - Nominated Adviser and Joint Broker +44 (0)20 7496 3000
Aubrey Powell / Justin McKeegan / Alex Bond (Corporate
Finance)
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332 2500
Dominic Wilson / Phil Walker
Image Box PR
Neil Hunter / Michelle Boxall +44 (0)20 8943 4685
About 4D
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's Live Biotherapeutic Products are orally delivered single
strains of bacteria that are naturally found in the healthy human
gut. The Company has five clinical studies in progress, namely a
Phase II clinical study of BLAUTIX(R) in Irritable Bowel Syndrome
(IBS), a Phase I/II study of MRx0518 in combination with
KEYTRUDA(R) (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 and a
Phase I/II study of MRx-4DP0004 in asthma. 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.
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(R) (pembrolizumab) in patients who have previously
progressed on anti PD-1 therapies. This study is being carried out
at MD Anderson (Houston, USA) 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 MRx0518-I-002 clinical trial
MRx0518-I-002 (NCT03637803) is a Phase I/II open-label, safety
and preliminary efficacy study of MRx0518 in combination with
KEYTRUDA(R) (pembrolizumab) in patients with solid tumours
(non-small cell lung cancer, renal cell carcinoma, bladder cancer
or melanoma) who have previously progressed on anti PD-1/PD-L1
therapy. Subjects are treated with intravenous KEYTRUDA(R) every
three weeks and one capsule twice daily of MRx0518. Treatment
continues as long as clinically relevant, until disease
progression, unacceptable AEs or withdrawal of consent up to a
maximum of 35 cycles of KEYTRUDA(R).
Part A was conducted in 12 patients (of any of the four tumour
types) and Part B will be conducted in up to 30 patients of each
tumour type.
This study is being carried out at The University of Texas MD
Anderson Cancer Center, Houston, USA, in collaboration with MSD,
the tradename of Merck & Co., Inc., Kenilworth, NJ, USA.
For further detail about the study please visit
https://clinicaltrials.gov/ct2/show/NCT03637803
About MRx-4DP0004
MRx-4DP0004 is a single-strain Live Biotherapeutic in
development for the treatment of asthma and COVID-19. It has
demonstrated strong and significant efficacy in industry standard
preclinical models of steroid-resistant severe asthma. MRx-4DP0004
was shown to reduce both neutrophils and eosinophils in
prophylactic and therapeutic settings in vivo. The efficacy was
also reflected in a reduction in histopathological lung
inflammation, and specific subsets of T cells, dendritic cells and
inflammatory cytokines.
4D is currently investigating MRx-4DP0004 in a Phase I/II study
in patients with partly-controlled asthma. The study, taking place
at sites across the UK and EU, is evaluating the safety and
preliminary clinical efficacy of MRx-4DP0004 in addition to
standard maintenance therapy such as inhaled corticosteroids (ICS)
and long acting beta agonists (LABA), in up to 90 patients. For
more information about the clinical study please visit
https://clinicaltrials.gov/ct2/show/NCT03851250 .
The Company has received expedited acceptance from the MHRA to
conduct a Phase II study of MRx-4DP0004 in up to 90 patients
hospitalized with suspected or confirmed COVID-19. For more
information about the clinical study please visit
https://clinicaltrials.gov/ct2/show/NCT04363372
For more information, refer to https://www.4dpharmaplc.com .
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END
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