120 | UK Enterprise Awards 2022 safety, a potential paradigm shift for patients who currently have to tolerate severe side effects as the cost of treatment. 4D pharma’s approach to the microbiome and Live Biotherapeutics is uniquely focused on function and mechanisms, and it is this which differentiates the firm from competitors in its field. 4D pharma views its LBPs like any other drug and selects candidates for development based on specific mechanisms it has identified in the lab which are thought to be relevant to a given disease. This is underpinned by its MicroRx platform, which is a multi-faceted platform for identifying and studying the specific activity of strains of bacteria. This approach – focused on function and not ecology – is just like traditional pharmaceutical drug development, applied to the untapped potential of the microbiome. This has allowed 4D pharma’s deep pipeline to expand for GI diseases like IBS to inflammatory-GI diseases like IBD, to systemic or distant inflammatory conditions like asthma and multiple sclerosis, to instead upregulating the immune system to treat cancer (known as immunotherapy or immunooncology), and more recently tapping into the gutbrain axis to treat neurodegenerative diseases like Parkinson’s and neurological conditions like autism. 4D pharma continues to break new ground for the rapidly emerging microbiome therapeutics field, claiming the world’s first positive clinical results for live biotherapeutics in cancer and asthma. Its unique approach has attracted multiple collaboration with world leaders like Merck & Co. (known as MSD outside of the US), Pfizer and Merck KGaA (Germany). Regarding new trends emerging within the microbiome field, there has been significant interest for at least a decade but only in the last few years is this excitement and potential being converted into results in clinical trials, the ultimate test of any new drug. 4D pharma and its peers are creating an entirely new class of drug. An important distinction for Live Biotherapeutics compared to other drugs is the incredibly clean safety profile that has been shown to date. 4D pharma is a pioneer in harnessing bacteria as a revolutionary new class of medicines – called live biotherapeutics. We find out more about this innovative medicine in the wake of the company being named in the prestigious UK Enterprise Awards 2022. 4D pharma is a biotechnology company leading the development of an entirely new class of drug, known as Live Biotherapeutic Products (LBPs), by tapping into the microbiome. The microbiome refers to the trillions of bacteria that live inside the human body – our bodies are home to more bacterial cells than human cells, and the microbiome holds roughly 100 times as many genes as the human genome. All of this biological and genetic material has co-evolved with the human host to have a critical role in human health, to the extent the microbiome is sometimes considered analogous to a new organ. It is not only essential for digestion and metabolism, but also closely involved in the functioning of the immune system, and even the nervous system. 4D pharma is exploiting these close bacterialhuman interactions to develop single strain Live Biotherapeutics. Each of its drugs is made up of a single specific strain of bacteria selected for its particular drug-like activity. 4D pharma has used its proprietary MicroRx platform to screen the human gut microbiome and identify single strain LBPs which are in development for a range of disease, not only for gastrointestinal (GI) diseases but also cancer, immune-inflammatory conditions like asthma, neurological conditions like Parkinson’s, autism, and vaccines. More than just exciting science, 4D pharma is already proving its LBPs in clinical trials. In recent months the company has reported positive clinical results in patients with cancer, asthma, irritable bowel syndrome, and announced plans to start a clinical trial for new LBPs in people with Parkinson’s disease. Importantly, each drug in development for these conditions is unique. 4D pharma is dedicated to its mission of delivering safe and innovative therapies for patients with high unmet needs. LBPs offer an entirely new way to treat a range of diseases, where innovation is sorely needed. Importantly, to date its LBPs have demonstrated excellent Leading Innovators in Biotherapeutics 2022 Apr22383 Supported by the hard evidence of clinical trial results and data, major pharmaceutical companies are getting increasingly involved in the microbiome field, with internal teams and establishing partnerships with biotechs like 4D pharma. As the field becomes more established, including the potential first ever approval of a microbiome drug [NB: not a 4D pharma drug] in late 2022 or early 2023, this trend is only set to accelerate. Recently, 4D pharma was recognised in the UK Enterprise Awards 2022 for being Leading Innovators in Biotherapeutics 2022, and the first half of 2022 was full of exciting progress for 4D pharma and its pipeline of LBPs. The company announced clinical trial successes in cancer and asthma, presented additional data from another trial in IBS, and announced a second collaboration around its cancer therapy MRx0518 with leading multinational pharmaceutical partners. Into 2023 the company has a number of exciting milestones coming up, including further updates on multiple clinical studies in cancer. Further data from its ongoing asthma clinical trial, and initiation of the world’s first study of a Live Biotherapeutic in Parkinson’s. Company: 4D pharma Web Address: www.4dpharmaplc.com
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