Stefan Bernstein explains how the EU/Greenland critical raw materials partnership benefits GreenRoc. Watch the full video here.

Less Ads, More Data, More Tools Register for FREE

Pin to quick picksDDDD.L Regulatory News (DDDD)

  • There is currently no data for DDDD

Watchlists are a member only feature

Login to your account

Alerts are a premium feature

Login to your account

Clinical Update - MRx0518 oncology programmes

29 Apr 2019 07:00

RNS Number : 2816X
4d Pharma PLC
29 April 2019
 

4D pharma plc

(the "Company" or "4D")

Clinical Update - MRx0518 oncology programmes

4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces an update on the clinical progress of its lead oncology Live Biotherapeutic, MRx0518.

Update on MRx0518 Phase I/II combination study with KEYTRUDA® (pembrolizumab)

The first patient participating in the combination phase I/II study of MRx0518 and *KEYTRUDA® in collaboration with Merck & Co., Inc., Kenilworth, NJ., USA and 4D's strategic collaboration with MD Anderson has completed Cycle 1 of Part A of the study with no dose limiting toxicities. This study is open-label and will recruit up to 132 patients with metastatic cancer across multiple cancer types (non-small cell lung cancer, renal cell carcinoma, bladder cancer and melanoma) who have failed prior anti-PD-1 therapy. Part A of the study will enrol 12 patients with the primary outcome measure to assess safety and tolerability. Patients will continue on therapy with follow-up assessments including the anti-tumour effect of the combination. Recruitment is progressing as expected and we anticipate completing Part A before the end of 2019. At this point, Part B of the study, which has a primary endpoint to assess the clinical benefit of the combination, will commence.

 

Commencement of Phase I MRx0518 neoadjuvant monotherapy

In addition, our phase I study of MRx0518 in a neoadjuvant setting has commenced. This placebo-controlled, phase I study at Imperial College London will evaluate MRx0518 as a monotherapy neoadjuvant in up to 120 treatment-naïve patients with solid tumours (melanoma, prostate, breast, ovarian, urothelial/bladder, renal, lung and head and neck cancers) who are due to undergo surgery as their first treatment. The primary endpoints of this study are safety and tolerability with secondary endpoints including tumour biomarker response, survival, immunological biomarkers and microbiome profiles. The principal investigator for this study is Dr. Jonathan Krell.

This study builds on the recently published data on the mechanism of action of MRx0518 that identified the bacterial flagellin (a specific component of the bacterium) as a potent stimulant of the innate and adaptive immune systems that interacts with the host TLR5 pathway known to be associated with the body's response to cancer. Oncology is a core area of development at 4D and the focus on expanding clinical programmes in this space demonstrates 4D's commitment to this disease area.

Duncan Peyton, 4D's Chief Executive Officer, commented: "We are delighted with the clinical progress of our oncology programme. The first patient completing Cycle 1 with no dose limiting toxicities gives us confidence that we may be able to report on early results of this study this year. The commencement of the monotherapy study will significantly strengthen our understanding of the potential of MRx0518 to impact treatment across a range of cancer settings. The novel study design will, for the first time, enable the evaluation of the anti-tumour immunological effects of a Live Biotherapeutic in treatment-naïve patients who will not be receiving concurrent therapy. We see our continued research and focus on the mechanism of action of our Live Biotherapeutic products as crucial to their further clinical development and regulatory approval as we build our oncology franchise."

For further information please contact:

4D

Duncan Peyton, Chief Executive Officer

Fay Weston, Head of Investor Relations

 

 

+ 44 (0)113 895 0130

+ 44 (0)7990 381713

Zeus Capital Limited - Nomad and Joint Broker

+44 (0) 161 831 1512

Dan Bate / Jordan Warburton

 

 

Bryan Garnier & Co. Limited - Joint Broker

+44 (0)20 7332 2500

Dominic Wilson / Phil Walker

 

About 4D

Founded in February 2014, 4D 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 that rationally identifies novel bacteria 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. 4D has three clinical studies in progress, namely a phase II clinical study of Blautix in Irritable Bowel Syndrome, a phase I/II study of MRx0518 in combination with Keytruda® in solid tumours and a phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumours. Other focus programmes include disease areas such as asthma and CNS disease. 

About Cancer

Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. Globally, it is estimated that there were around 18 million new cases in 2018 and that almost 10 million people died of cancer, making it the leading cause of death world-wide. The number of new cancer cases per year is expected to rise to 23.6 million by 2030. The global market for oncology drugs is expected to reach $111.9bn by 2020.

The microbiome has been implicated in cancer treatment and response in a range of clinical settings including standard chemotherapy. The microbiome profile of patients has been demonstrated to drive response to anti-PD-1 therapy in both melanoma and non-small cell lung cancer.

About MRx0518

As both a monotherapy and in combination settings MRx0518 has demonstrated robust efficacy as an immuno-stimulant and anti-tumour agent in multiple tumour models such as breast cancer, renal cell carcinoma and lung cancer. MRx0518 acts on both the innate and adaptive immune system to induce a response mediated by TLR-5.

The Company is investigating MRx0518 across a range of clinical cancer settings in 2019. In collaboration with Merck, Sharpe & Dohme (Merck & Co. Inc), MRx0518 is being evaluated in an open label Phase I/II study of MRx0518 in combination with Keytruda® in patients with solid tumours who have failed prior anti-PD-1 therapy. A phase I randomised, placebo-controlled study of MRx0518 as a monotherapy in a neoadjuvant setting for solid tumours has also commenced.

For more information, refer to https://www.4dpharmaplc.com/

*KEYRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
 
END
 
 
NRAPGUWWCUPBGPQ
Date   Source Headline
16th Feb 20237:00 amRNSCancellation - 4d Pharma Plc
15th Feb 20231:16 pmRNSCancellation of admission to trading on AIM
2nd Feb 20233:10 pmRNSUpdated Results from Renal Cell Carcinoma Cohort
16th Jan 202310:15 amRNSResult of Meeting
30th Dec 202212:30 pmRNSUpdate on Administration and Suspension of Trading
16th Nov 20227:00 amRNSBlautix Phase II Clinical Trial Results Published
10th Nov 20222:00 pmRNSMRx0518 SITC 2022 poster presentations
5th Oct 20221:00 pmRNSMRx0518 poster presentations at SITC 2022
29th Sep 202210:00 amRNSUpdate on Suspension of Trading on AIM
24th Aug 20227:00 amRNSPublication of preclinical autism research
4th Aug 20223:33 pmRNSPublication of Joint Administrators' Proposals
1st Jul 20225:33 pmRNSTemporary Pause of Recruitment in Clinical Trials
28th Jun 20226:28 pmRNS4D Pharma receives Notice of Delisting from NASDAQ
28th Jun 20223:15 pmRNSResult of AGM
27th Jun 20225:30 pmRNS4D Pharma
24th Jun 20226:22 pmRNSUpdate on Suspension of Trading
24th Jun 202212:30 pmRNSSuspension - 4D Pharma PLC
24th Jun 202212:30 pmRNSTemporary Suspension
14th Jun 20227:00 amRNSPre AGM-Investor Presentation and Q&A
7th Jun 202211:00 amRNSExercise of Options and Total Voting Rights
27th May 20227:00 amRNSASCO 2022 MRx0518 and Bavencio Trial In Progress
25th May 20221:51 pmRNSAnnual Report and Notice of AGM
17th May 20227:00 amRNSATS 2022 - MRx-4DP0004 Phase I/II Part A poster
1st Apr 20227:00 amRNSFinal Results
24th Mar 202210:50 amRNSHolding(s) in Company
23rd Mar 20227:00 amRNSMRx0518 + Keytruda - Primary endpoint met in RCC
21st Mar 202210:46 amRNSHolding(s) in Company
9th Mar 20227:00 amRNSForm F3 Registration Statement filed with SEC
24th Feb 20227:21 amRNSHolding(s) in Company
23rd Feb 20227:00 amRNSParticipation in Chardan Microbiome Summit
22nd Feb 20227:00 amRNSParkinson’s trial receives FDA IND clearance
18th Feb 20227:00 amRNSRestatement of Interim Results to June 30, 2021
27th Jan 20227:00 amRNSAdditional MRx04 Phase 1/2 asthma data and event
25th Jan 20225:17 pmRNSHolding(s) in Company
20th Jan 20227:00 amRNS4D pharma to host virtual KOL event
6th Jan 202210:07 amRNSHolding(s) in Company
5th Jan 20227:00 amRNSParticipation in Upcoming Investor Conference
4th Jan 20227:00 amRNS4D pharma appoints John Doyle as CFO
4th Jan 20227:00 amRNSGrant of Options
13th Dec 20217:00 amRNS4D pharma Phase 1/2 asthma study Part A results
9th Dec 20217:00 amRNS4D pharma presents IBS Phase 2 microbiome analysis
7th Dec 20212:19 pmRNSHolding(s) in Company
19th Nov 20215:58 pmRNSHolding(s) in Company
11th Nov 20217:00 amRNS4D pharma Jefferies Healthcare Conference
12th Oct 20217:00 amRNSJefferies Next Generation IBD Therapeutics Summit
30th Sep 20217:00 amRNSHalf-year Report
16th Sep 20212:08 pmRNSHolding(s) in Company
15th Sep 20217:00 amRNS4D pharma presents two posters at ESMO Congress
9th Sep 20217:00 amRNSParticipation in Upcoming Investor Conferences
19th Aug 20219:44 amRNSHolding(s) in Company

Due to London Stock Exchange licensing terms, we stipulate that you must be a private investor. We apologise for the inconvenience.

To access our Live RNS you must confirm you are a private investor by using the button below.

Login to your account

Don't have an account? Click here to register.

Quickpicks are a member only feature

Login to your account

Don't have an account? Click here to register.