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, Development Director, 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.
For more information, refer to www.4dpharmaplc.com.
This announcement contains “forward-looking statements.” All statements other than statements of historical fact contained in this announcement, including without limitation statements regarding timing of clinical trial commencement, LBP manufacturing, production capacity and commercialization are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the United States Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements are often identified by the words “believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could,” “may,” “estimate,” “outlook” and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company’s current expectations, beliefs and assumptions concerning future developments and business conditions and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates.
All of the Company’s forward-looking statements involve known and unknown risks and uncertainties, some of which are significant or beyond its control, and assumptions that could cause actual results to differ materially from the Company’s historical experience and its present expectations or projections. The foregoing factors and the other risks and uncertainties that affect the Company’s business, including the risks of delays in the timing of clinical trial commencement, risks relating to the Company’s manufacturing facilities, and those additional risks and uncertainties described the documents filed by the Company with the US Securities and Exchange Commission (“SEC”), should be carefully considered. The Company wishes to caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any of its forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise, except to the extent required by law.
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