Microbiome- Competitive Landscape, 2022

Microbiome- Competitive Landscape, 2022

DelveInsight’s, Microbiome - Competitive landscape, 2022,” report provides comprehensive insights about 130+ companies and 200+ drugs in Microbiome Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Geography Covered • Global coverage Microbiome Understanding Microbiome Overview Microbiome refers to collection of microbes and their interaction with the human body. Microbiome plays an important role in human physiology and disease. The microbes and their interaction with the human body show the various aspects of human biology. Human body possess a number of different species particularly bacteria and fungi which help in digesting food, preventing infections and performing numerous life-supporting tasks. Microbes can also be harmful to their human hosts. Microbiome if well understood can be used as personalized medicine which can be tailor made according to the patient’s need. The reprogramming of the gut bacteria to perform certain functions can be used for treating various conditions by restoring the gut microbiome. Since body’s own gut microbes are going to be modified or altered, there are no chances of serious side effects that could be seen. The main focus why microbiome can be the future medicine is their important property of changeability. Depending on the requirement of gut environment the microbes and the community changes from time to time which can help us target specific microbiome that might be causing a disease or is causing an imbalance and thus improper functioning. Using these properties one can alter the functioning and thus be a potential therapeutic treatment method. Currently, there are no approved microbiome drugs available in the market so due to this many companies are racing to develop new drugs or aiming at developing therapies that can alter the microbiome for the benefit of human health. Proper monitoring of the microbial flora has a potential for early diagnosis of many diseases and thus can be used as a treatment strategy for conditions that have been proved untreatable with conventional methods Report Highlights • In July 2022, Tate & Lyle, a leading global provider of food and beverage ingredients and solutions, is delighted to announce that it is extending its partnership with APC Microbiome Ireland, a Science Foundation Ireland (SFI) Research Centre, through a new two-year research project to increase understanding of how dietary fibres can impact the functioning of the gut microbiome. • In June 2022, Microbiome DX company Genetic Analysis AS (“GA”) and Servatus Biopharmaceuticals Ltd (“Servatus”), have entered a Strategic Collaboration Agreement to combine their respective expertise to further advance the microbiome diagnostics and therapeutics markets. The collaboration will bring together Servatus’ world class knowledge of biotherapeutics and GA’s microbiome diagnostic signature analysis to develop new diagnostic markers and treatment options to ultimately improve the lives of patients worldwide. • In May 2022, Gnubiotics Sciences SA (Gnubiotics), announced a strategic partnership agreement with ADM, a global leader in human and animal nutrition. The strategic partnership is centered on the commercialization of innovative microbiome solutions for companion animal health and wellbeing. This strategic partnership provides ADM with unique access to cutting edge technologies and a pipeline of microbiome-focused innovation from Gnubiotics. • In January 2022, BiomeBank, which has recently launched its Series-A funding round, has signed a four-year collaborative agreement with Hudson Institute to translate current and future microbiome research into microbial therapies. This includes a recent deal granting BiomeBank access to important research on how the microbiota could treat paediatric IBD, which is unique because the research used culturing and high-resolution microbial analysis of the colon rather than stool samples. The partnership strengthens Hudson Institute’s business case for an Australian-first National Centre for Inflammation Research (“NCIR”) and will initially focus on the development of defined and targeted microbial therapies to treat unmet medical need for patients with Inflammatory Bowel Disease (“IBD”). • In December 2021, Kaleido Biosciences, Inc. announced the extension and expansion of its research collaboration with Janssen Biotech, Inc. (“Janssen”). The collaboration is designed to explore the potential for Microbiome Metabolic Therapies (MMT™) to prevent childhood-onset of atopic, immune and metabolic conditions by promoting healthy function of the gut microbiome. Company Profiles & their Late-stage Drug Profiles 1. Company Overview: AOBiome AOBiome Therapeutics is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local, nasal and systemic inflammatory conditions. AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company’s portfolio includes three clinical-stage programs, a Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. The company has selected its lead candidate based upon pre-clinical and clinical results from those trials. The company has recently completed enrollment of 547 patients in a double blind placebo controlled trial for the treatment of adults with pruritus associated with atopic dermatitis in support of its lead program. Other programs, including Phase 3 acne, may be pursued at a later date. Product Description: B244 AOBiome’s B244 is a patented, proprietary, topical formulation incorporating a single live strain of ammonia-oxidizing bacteria (AOB) Nitrosomonas eutropha D23. It metabolizes the ammonia found in sweat, creating both nitrite and nitric oxide, with both anti-inflammatory and anti-infective properties. The therapeutic drug was designed to repopulate the skin microbiome with AOBs which are normally found on the body but are stripped away by most soaps. Once deployed on the skin, B244 converts ammonia to nitrate, which is known to have anti-bacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be well-tolerated in clinical studies to date. Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31. 2. Company Overview: 4D Pharma 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 pharma 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, and Blautix® in irritable bowel syndrome (IBS) which has completed a successful Phase II trial. A Phase I study of MRx0005 and MRx0029 in patients with Parkinson’s disease is expected to commence in 2022. Additional preclinical-stage programs include candidates for CNS disease, immune-inflammatory conditions and cancer. Product Description: Blautix Blautix is an orally administered drug under development by 4D Pharma. The Drug is in the Phase II stage of development for the treatment of Irritable bowel disease (IBD). Blautix is a single-strain human gut commensal bacterium with a distinctive metabolism which may allow the treatment of IBS. Inside the gut, Blautix consumes gases which are known to cause bloating, abdominal pain, and changes in bowel frequency. The company completed a successful Phase Ib clinical study of Blautix in IBS patients and according to the company, the results were encouraging and provided a solid basis for progressing Blautix into larger clinical studies and further evaluation as a potential treatment for IBS. 3. Company Overview: MatriSys Biosystem MatriSys Bioscience is leading the discovery and clinical development of a novel class of biopharmaceuticals to transform the treatment of inflammatory skin diseases. Our groundbreaking technology platform identifies beneficial bacteria derived from healthy human skin to treat the millions of children and adults suffering from difficult to treat chronic skin diseases. With the lead clinical program in patients with Atopic Dermatitis, we are also rapidly advancing therapeutics for Acne and Rosacea. Product Description: MSB-01 MSB-01, an anhydrous topical formulation of Staphylococcus hominis strain A9 (Sh-A9) is a topical, highly selective antimicrobial live bio-therapeutic product that replaces the good bacteria that are deficient on the skin on Atopic Dermatitis (AD) patients. It is a commercially viable room-temperature stable topical formulation of freeze-dried S. hominis Strain A9 bacteria for application to the lesional skin of AD patients. AD is associated with the imbalance of skin microbes and a high susceptibility to infection by Staphylococcus Aureus (S. aureus). Staphylococcus hominis strain A9 (S. hominis Sh-A9) present in MSB-01 is selective and potent against the “Bad Bug” S. aureus. Unlike other antibiotics, S. hominis Sh-A9 does not affect other skin microbes and thus leads to the rebalance of the natural skin microbiome. The therapeutic product, MSB-01 is currently in Phase II stage of development for the treatment of Atopic Dermatitis. MSB-01 project is being developed for both therapeutic and cosmetic/skin care endpoints. 4. Company Overview: Vedanta Biosciences Vedanta Biosciences is leading the development of a potential new category of oral therapies based on defined consortia of bacteria isolated from the human microbiome and grown from pure clonal cell banks. The company’s clinical-stage pipeline includes product candidates being evaluated for the treatment of high-risk C. difficile infection, inflammatory bowel diseases, food allergy, liver disease, and cancer. Vedanta Biosciences controls a foundational portfolio of more than 45 patents and has built what it believes is one of the largest libraries of bacteria derived from the human microbiome. Proprietary capabilities include deep expertise in consortium design, vast datasets from human interventional studies, and CGMP-compliant manufacturing of oral Live Biotherapeutic Product (LBP) candidates containing pure, clonally-derived bacterial consortia in powdered form. Product Description: VE-202 Vedanta Biosciences, a company of PureTech is developing an innovative class of drugs based on research into the human microbiome. Company’s lead product VE202, a microbiome derived therapeutic is in phase I stage of development for the treatment of inflammatory bowel disease (or IBD) and its variants Crohn's Disease (CD) and Ulcerative Colitis (UC). Vedanta believes that VE202 has the potential to be a safer and potentially more efficacious alternative to current IBD drugs such as corticosteroids, anti-tumor necrosis factors, purine analogs, and antibiotics. 5. Company Overview: Evelo Biosciences Evelo Biosciences is a clinical stage biotechnology company developing orally delivered medicines that are designed to act on the small intestinal axis, SINTAX™, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. Evelo’s first product candidates are pharmaceutical preparations of single strains of microbes selected for their potential to offer defined pharmacological properties. Evelo’s therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases and cancer. Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas. Product Description: EDP1815 EDP1815 is Evelo Biosciences second monoclonal microbial product candidate being developed for the treatment of inflammatory diseases. EDP1815 is currently in phase I for the treatment of Atopic Dermatitis and Psoriasis. Currently, the drug is in Phase II stage of clinical trial evaluation for the treatment of Psoriasis and Atopic Dermatitis. Further product details are provided in the report…….. Future of Competitive Landscape of COVID-19 is estimated to be very strong. Key emerging drugs include B244, VE-202 and many other. MICROBIOME Analytical Perspective by DelveInsight • In-depth MICROBIOME analysis: Assessment of Products The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition – deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form. • MICROBIOME clinical assessment of products The report comprises of comparative clinical assessment of products by development stage, product type, and route of administration, molecule type. MICROBIOME Report Assessment • Company Analysis • Therapeutic Assessment • Pipeline Assessment • Inactive drugs assessment • Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: • How many companies are developing MICROBIOME drugs? • How many MICROBIOME drugs are developed by each company? • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of MICROBIOME? • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the MICROBIOME therapeutics? • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? • What are the clinical studies going on for MICROBIOME and their status? • What are the key designations that have been granted to the emerging and approved drugs?   Key Players • Evelo Biosciences • Vedanta Biosciences • MatriSys Biosystem • 4D Pharma • AOBiome • Caelus Health • DA Volterra • Debiopharm • Enterome Bioscience • Rebiotix • Finch Therapeutics Group • Igen Biotech Group • ImmuneBiotech • Precigen Inc • Immuron • Kaleido Biosciences • YSOPIA Bioscience • MaaT Pharma • Microbiome Therapeutics • MyBiotics • Naked Biome • Nubiyota • OxThera • Pylum Biosciences • Ritter Pharmaceuticals • Seres Therapeutics • Symberix • Symbiotix Biotherapies • Xycrobe Therapeutics • Boehringer Ingelheim Key Products • EDP1815 • VE-202 • MSB-01 • Blautix • B244 • MRx 518 • Thetanix • ABI-M201 • ABI-M301 • AZT-04 • CP 001 • DAV 132 • Debio 1453 • Debio 1454 • Debio 1454M • EB-8018 • EDP 1503 • RBX 2660 • MaaT 013 • MaaT 033 • RBX 7455 • FIN-525 • FIN-524 • Antibody-toxin conjugates • CP101 • FIN-211 • IMM-529 • IMM-124E • AG 019 • AG017 • KB 195 • KB174 • KB 109 • Yso1 • Yso 2 • Yso3 • Yso4 • Yso5 • MaaT 03X • MSB 3163 • MSB 5710 • MSB 2040 • MSB 2179 • MSB 6005 • MSB 4249 • SER-109 • SER-155 • SER 287 • SER 301

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