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4D pharma to present at the Microbiome Movement Drug Development Summit

4D pharma to present at the Microbiome Movement Drug Development Summit

Leeds, UK, June 22, 2021, - 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) - a novel class of drug derived from the microbiome, today announces Christophe Carite, Director CMC & Development, will deliver a presentation on 4D pharma’s strategy and capabilities for the manufacturing of its Live Biotherapeutic drug candidates at the upcoming virtual Microbiome Movement Drug Development Summit, on Thursday, July 1 at 2.15pm EDT (7.15pm BST). He will also participate in a microbiome therapeutics manufacturing roundtable panel session.

The presentation will discuss 4D pharma’s strategies, technologies and facilities to address the challenges of clinical-grade manufacturing and scale-up of its LBPs as a novel therapeutic modality for the treatment of a range of indications with unmet needs, including oncology, asthma, Parkinson’s disease and irritable bowel syndrome. The Company has successfully conducted the manufacturing optimization and scale-up of multiple novel LBPs at its in-house cGMP facility, and to date has progressed four candidates into clinical trials with additional candidates expected to enter the clinic in 2022.

In addition, Christophe Carite will join a panel entitled ‘Effectively scaling up microbiome manufacturing’. This roundtable will discuss the future of GMP infrastructure for microbiome therapeutics, the most effective quality control processes and potency methods, and the merits of developing internal manufacturing facilities or using CDMO partners.

As 4D pharma has led the development of LBPs it has built leading drug discovery and development expertise in this new field. The Company has also developed unparalleled know-how, processes and facilities for the manufacture of its LBPs to the highest regulatory standards. 4D pharma has fully cGMP-certified facilities in Europe, housing two 3,000L fermenters and downstream processing facilities with production capacity sufficient for late clinical and early commercial scale. Further, 4D pharma management were previously invited to contribute to the drafting of the European Pharmacopoeia’s quality standards for Live Biotherapeutic products which became effective in 2019.

“4D pharma’s unique expertise in the efficient, scalable and reproducible manufacturing of single strain LBPs has been invaluable in supporting rapid clinical and pre-clinical progress across our pipeline,” said Christophe Carite, Development Director, 4D pharma. “Having these capabilities in-house not only supports and accelerates progress, but also generates valuable know-how, intellectual property and competitive advantage. As Live Biotherapeutics near commercialization, manufacturing is increasingly recognized as a critical factor in the future of this novel drug class, and 4D pharma is well positioned to successfully manage this important aspect of drug development in-house.”

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 five 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), 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.

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Last Updated: 24-Jun-2021