Microbiome - Competitive landscape, 2023

This “Microbiome- Competitive landscape, 2023” report provides comprehensive insights about 130+ companies and 180+ 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. Role of Microbiota in Health and Disease are in Metabolic Disorders: Various studies have demonstrated that microbiota plays a very important role in pathophysiology of metabolic disorders especially obesity and diabetes. In metabolic diseases the characteristic features of metabolic disorders such as insulin resistance, increased intestinal absorption of monosaccharides, increased expression levels of lipogenetic enzymes (acetyl-CoA carboxylase and fatty acid synthase), enhanced triglyceride synthesis and increased leptin level has been observed. In Inflammatory Bowel Diseases: Microbiome affects the inflammatory disease by causing changes to the metabolism of the host. Inflammatory bowel diseases can affect the intestinal tract which leads to microbial changes. The inflammatory process in IBD could be affected by the host genetics and certain environmental factors like diet. In Cancers: Studies have shown tumor-promoting effects of the microbiota in spontaneous, genetically-induced and carcinogen-induced cancers in various organs, including the skin, colon, liver, breast and lungs. Cancer has seen to promote dysbiotic microbiomes. 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.

Report Highlights

• In April 2023, ADM, a global leader in nutrition that powers many of the world's top food, beverage, and health and wellness brands, and Brightseed, the bioactives company and a World Economic Forum Global Innovator, announced a global joint partnership to develop evidence-based functional synbiotic products that target microbiome optimization with an undisclosed investment. ADM is leveraging Brightseed's artificial intelligence (A.I.) platform, Forager®, to decipher the molecular interactions between dietary plants and gut microbes, and their potential impact on human health.
• In March 2023, Sequential Skin Inc. ("Sequential"), the skin microbiome company developing next generation non-invasive skin testing and data-driven solutions for the skin microbiome, announced that it has entered into a collaboration agreement with Johnson & Johnson Consumer Inc. The collaboration will focus on developing new methods for non-invasive genomic-based skin testing, to help Sequential add to their growing database of skin samples.
• In March 2023, Holobiome announces research collaboration with Johnson & Johnson Consumer Inc. to develop next-generation probiotics and prebiotics, aimed at supporting infant and maternal immune health. The collaboration is the latest in a string of collaboration deals between the two companies, and marks Holobiome's first foray into the arena of the early-life microbiome. The research collaboration with Johnson & Johnson Consumer Inc. will leverage Holobiome's platform to identify, isolate, and develop next-generation probiotic bacteria and the prebiotics that help them flourish.
• In February 2023, The University of Texas MD Anderson Cancer Center and Federation Bio, a biotechnology company pioneering bacterial cell therapies, announced a strategic collaboration to design and manufacture a complex, synthetic microbial consortium with the goal of expanding the number of cancer patients who respond to immunotherapy. The agreement pairs Federation Bio's proprietary ACT™ (anerobic co-culture technology) platform with the expertise and capabilities of MD Anderson's Platform for Innovative Microbiome and Translational Research (PRIME-TR).
• In January 2022, BiomeBank, 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 pediatric 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 November 2022, EnteroBiotix (EBX), announced a partnership with Imperial College London (Imperial) to develop microbiome R&D in patients suffering from blood cancer. The collaboration also aims to accelerate systematic research in the new science of the microbiome. EBX and Imperial are combining to manage a phase 2 investigator-initiated trial, to evaluate how EBX-102 impacts on outcomes of bone marrow transplant patients with blood cancer. The trial, which is funded by the Medical Research Council - forms part of the Microbiota Transplant Prior to Allogeneic Stem Cell Transplantation study, run across six of the UK's leading blood cancer centers.

Microbiome: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Ferring pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women's health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company's research and development investment goes towards finding innovative and personalized healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. In April 2018, Ferring Pharmaceuticals and Rebiotix Inc. announce that they have agreed to the acquisition of Rebiotix by Ferring.

Product Description: RBX 2660

Rebiotix (acquired by Ferring pharmaceuticals) is developing a Microbiota Restoration Therapy (MRT) with RBX2660 an enema formulation as its lead candidate. RBX2660 (microbiota suspension) is a non-antibiotic preparation containing live microbes designed to rebuild a healthy intestinal microbiome and has the potential to be the first human microbiome product approved anywhere in the world. RBX2660 is also being evaluated in Phase I for the treatment of VRE Elimination, Pediatric Ulcerative Colitis, Multi-Drug Resistant UTI and Hepatic Encephalopathy. RBX2660 is administered using the technique enema. It has been granted orphan drug designation, fast track designation and breakthrough therapy designation from the U.S Food and Drug Administration. REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. REBYOTA is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration. REBYOTA is sourced from qualified donors and tested for a panel of transmissible pathogens.

Microbiome: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Seres Therapeutics

Seres Therapeutics, Inc. is a leading microbiome therapeutics company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres' SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced to prevent further recurrences of C. difficile infection and has potential to become a first-in-class oral FDA-approved microbiome therapeutic. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation to reduce incidences of gastrointestinal infections, bloodstream infections and graft-versus-host disease as well as additional preclinical stage programs targeting Infection Protection in medically compromised patients. The Company is also conducting research to inform further development of microbiome therapeutics for ulcerative colitis.

Product Description: SER-109

SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores, which normally live in a healthy microbiome. It was developed utilizing the company's Microbiome Therapeutics platform to understand the ecologies of disease associated with CDI. The SER-109 manufacturing purification process is designed to remove unwanted microbes, thereby reducing the risk of pathogen transmission beyond donor screening alone. The FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the prevention of rCDI. The U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for investigational oral microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection (rCDI).

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 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. 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.

Product Description: Blautix

Blautix® is a single strain Live Biotherapeutic product (LBP), being developed as a treatment for irritable bowel syndrome (IBS). Pre-clinical studies demonstrated its ability to address visceral hypersensitivity and other symptoms of IBS and increase microbiome diversity. A Phase II randomized controlled clinical trial demonstrated an impact on overall response with regards to bowel habit and abdominal pain in both patients with IBS with constipation (IBS-C) or IBS with diarrhoea (IBS-D).Blautix® was well tolerated, with a safety profile comparable to placebo. Currently the drug is in Phase II stage of Clinical trial evaluation for the treatment of Irritable bowel syndrome.

3. Company Overview: Scioto Biosciences, Inc.

Based in Fishers, Indiana, Scioto Biosciences is a clinical-stage biotechnology company developing innovative therapies devoted to having a transformative impact on the delivery of live bacterial therapeutics (LBTs). Lead product, SB-121, is in clinical development for autism spectrum disorder. Scioto's Activated Bacterial Therapeutic (ABT) Platform has the potential to enhance efficacy wherever LBTs are used such as gastrointestinal health, diabetes, neurological disorders, alternatives to in-feed antibiotics (in livestock) and others.

Product Description: SB-121

SB-121, based on its novel microbiome delivery platform, Activated Bacterial Therapeutics (ABT), which is designed to deliver best-in-class, live therapeutic bacteria to the gut. Top-line results from the study demonstrated that SB-121 was safe and well tolerated. The most common adverse events, irrespective of treatment group, were abdominal pain, vomiting, and diarrhea. The majority of adverse events were mild, and none were serious or severe. There were no discontinuations due to adverse events. Additionally, there were treatment-associated improvements noted in the Vineland-3™ adaptive behavior assessment and in measures of eye tracking.

4. Company Overview: Seres Therapeutics

Seres Therapeutics, Inc., is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres' SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres' SER-287 program has obtained Fast Track and Orphan Drug designations from the FDA and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres is evaluating SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 in a Phase 1b study in patients with ulcerative colitis and SER-155 to prevent mortality due to gastrointestinal infections, bacteremia and graft versus host disease.

Product Description: SER-301

SER-301 was developed with innovative and novel manufacturing methods that do not require human donor material. It includes strains delivered in spore form and strains fermented in non-spore (vegetative) form. The product candidate is delivered using enterically-protected technology designed to release in the colon. GMP manufacturing technologies developed through the SER-301 program broaden the breadth of biology that can be incorporated into Seres' microbiome therapeutics.

Microbiome Analytical Perspective

In-depth Commercial Assessment: Microbiome Collaboration Analysis by Companies

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 Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Microbiome Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions Answered

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

• Ferring Pharmaceuticals
• Miyarisan Pharmaceutical
• Seres therapeutics
• 4D Pharma
• Caelus Health
• MRM Health
• Scioto Biosciences
• Adiso Therapeutics
• Servatus Biopharmaceuticals
• Second Genome
• Finch Research and Development LLC.
• MaaT Pharma
• Qu Biologics
• Da Volterra
• Exeliom Biosciences

Key Products

• RBX 2660
• Miya-BM
• SER-109
• Blautix
• SB-121
• ADS024
• SER-301
• CH-0106
• MH002
• SVT 1A4710
• SG 500455
• QBKPN
• DAV 132
• EXL01
• MaaT 033
• MaaT 013
• Thetanix

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