4D pharma announces three presentations at The Society for Immunotherapy of Cancer (SITC) Annual Meeting 2020

Initial immune modulation and safety data from MRx0518 neoadjuvant monotherapy trial in patients awaiting surgical resection of solid tumors

Update on safety and efficacy results of Part A of combination trial of MRx0518 and Keytruda(R) in patients refractory to immune checkpoint inhibitors

Further information on ongoing Part B cohort expansion phase of MRx0518 and Keytruda(R) combination trial

Leeds, UK - October 14, 2020 - 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces the acceptance of multiple presentations at the Society for Immunotherapy of Cancer (SITC) 35th Annual Meeting, November 9-14, 2020. The three posters will focus on two of 4D pharma’s clinical trials of lead immuno-oncology single strain Live Biotherapeutic MRx0518.

The first poster will describe initial immune modulation and safety data from the MRx0518 neoadjuvant monotherapy trial in patients awaiting surgical resection of solid tumors.

Two further posters will provide details of the MRx0518 and Keytruda(R) (pembrolizumab) combination study in patients who are refractory to immune checkpoint inhibitors. One will provide an additional update on safety and clinical efficacy in patients from the concluded Part A of the study. The second will provide information on the ongoing cohort expansion phase of the trial, Part B.

“4D pharma is building significant amounts of clinical oncology data that demonstrate the potential of single strain Live Biotherapeutics as treatments for a range of solid tumors, including refractory patients with no alternative treatment options. It is critical for us to share this ground-breaking data at events like SITC to continue to push this exciting field forward,” said Dr. Alex Stevenson, Chief Scientific Officer of 4D pharma. “For the first time, we will be reporting initial immune modulation and safety data from 4D pharma’s study of the MRx0518 as a neoadjuvant monotherapy. This data could be particularly important in developing our understanding of the mechanism of action of MRx0518 in the clinical setting, a key component of maximising its potential as a novel immuno-oncology therapeutic. In addition, having reported initial proof-of-concept for the MRx0518 and Keytruda combination study earlier this year, SITC provides the ideal platform to provide an update on progress with this study.”

SITC 2020 Poster Presentation Details:

Safety and emerging evidence of immune modulation of the live biotherapeutic MRx0518 in the neoadjuvant setting for patients awaiting surgical removal of solid tumors

Abstract Number: 805

Presented: 11-14 Nov Virtual Poster Hall

Q&A Session: 11 Nov 5:15-5:45pm EST & 13 Nov 4:40-5:10pm EST

A phase I/II study of live biotherapeutic MRx0518 in combination with pembrolizumab in patients refractory to immune checkpoint inhibitors

Abstract Number: 710

Presented: 11-14 Nov Virtual Poster Hall

Q&A Session: 12 Nov 4:50-5:20pm EST & 14 Nov 1-1:30pm EST

Safety and efficacy signals in the complete phase I study of live biotherapeutic MRx0518 in combination with pembrolizumab in patients refractory to immune checkpoint inhibitors (ICIs)

Abstract Number: 609

Presented: 11-14 Nov Virtual Poster Hall

Q&A Session: 11 Nov 5:15-5:45pm EST & 13 Nov 4:40-5:10pm EST

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's Live Biotherapeutic Products 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 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.