Microbiome Pipeline Landscape

DelveInsight’s, “Microbiome - Competitive landscape, 2025,” report provides comprehensive insights about 140+ 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 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.

Role 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. 

Role 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 July 2024, Kanvas Biosciences, announced that it has raised $12.5 million in additional funding co-led by existing investors DCVC and Lions Capital LLC, and participation from FemHealth Ventures, Germin8, Ki Tua Fund, and Pangaea Ventures as well as existing investors. Kanvas Biosciences secures additional $12.5M to advance its novel, microbiome-based immuno-oncology drug candidates to IND filing.
• In May 2024, Biomica Ltd. announced encouraging initial findings from an ongoing Phase I clinical trial. In the study, Biomica is investigating the safety and tolerability of its microbiome-based immuno-oncology candidate, BMC128, in combination with nivolumab, an anti-PD1 immune checkpoint inhibitor, in patients with non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC).
• In May 2024, BIOM Pharmaceutical Corporation announced that Bi104, its innovative drug product, had been granted Orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of Angelman syndrome (AS).
• In March 2024, Liveome, an affiliate of Medytox completed the Phase I clinical trial in Australia for its gene-recombinant microbiome drug, LIV001. The drug is being developed as a treatment for inflammatory bowel disease, a chronic immune disorder that has been challenging to manage with existing therapies.
• In February 2024, Evogene Ltd. and Verb Biotics LLC. entered into a collaboration agreement that will focus on the development of new strains of probiotic bacteria, which produce a highly sustainable quantity of microbial metabolites that improve human health and vitality. The collaboration will focus on identifying and enhancing the currently unknown genetic pathways in microbes that support the production of novel metabolites, using Evogene's MicroBoost AI tech-engine and Verb Biotics' extensive accumulated knowledge in the field of the microbiome.
• In December 2023, Ferring Pharmaceuticals has signed a research and development partnership and licensing agreement with PharmaBiome to develop new microbiome-based therapies in gastroenterology. The alliance will combine Ferring’s development and commercial expertise with the technology of PharmaBiome to manufacture new donor-independent microbiome-based treatments.
• In March 2023, CJ Bioscience announced that it had signed a contract to take over new drug candidates and their platform technology with 4D Pharma, a company based in the United Kingdom and Ireland. Under the contract, CJ Bioscience will introduce nine new drug candidate substances with the targeted indications of solid cancer, gastrointestinal diseases, brain diseases, and immune diseases. In addition, the company said it would secure 10 pipelines by 2025.

Microbiome: Company and Product Profiles (Marketed 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

VOWSTTM (fecal microbiota spores, live-brpk), formerly called SER-109, is an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). VOWST is not indicated for the treatment of CDI. The FDA approval of VOWST was supported by a robust Phase 3 development program that included the ECOSPOR III and ECOSPOR IV studies. VOWST was previously granted Breakthrough Therapy and Orphan Drug Designations by the FDA. SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores, which normally live in a healthy microbiome. SER-109 is designed to reduce the recurrence of CDI by modulating the disrupted microbiome to a state that resists C. difficile colonization and growth. 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.

2. Company Overview: Acerus Pharmaceuticals/Medinova

Acerus is a Canadian-based pharmaceutical company focused on the commercialization and development of innovative pharmaceutical products that improve the patient experience. Founded in 2008, Acerus has grown into a fully integrated specialty pharmaceutical company with expertise in all stages of the pharmaceutical product life-cycle. The company is focused on Men’s Health (Urology and Andrology). Acerus operates from a Mississauga-based office, and is listed on the Toronto Stock Exchange (TSX:ASP) and the OTCQB Exchange (OTCQB: ASPCF).Acerus (ay-SAIR-us) – Derived from the Latin root word ‘acer’, signifying a fierce and sharp mind, and passionate and energetic action. It also represents a genus of trees commonly known as the maple, the official tree and symbol of Canada.

Product Description: Gynoflor

GYNOFLOR is an ultra-low dose estrogen (estriol) and probiotic (Lactobacillus acidophilus) combination vaginal tablet used for the treatment of symptoms of vaginal atrophy due to estrogen deficiency during menopause and post-menopause, for the restoration of vaginal flora following the use of anti-infectives and for the treatment of certain vaginal infections. GYNOFLOR is approved in 41 countries across Europe, Asia-Pacific, the Middle East, Africa and South America, and it is estimated that up to 32.7 million women worldwide have been treated with the product to date.

Microbiome: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: MaaT Pharma

MaaT Pharma, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, MaaT Pharma has launched, in March 2022, an open-label, single arm Phase III clinical trial in patients with acute GvHD, following the achievement of its proof of concept in a Phase II trial. Its powerful discovery and analysis platform, gutPrint®, enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company’s Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice. MaaT Pharma is listed on Euronext Paris (ticker: MAAT).

Product Description: MaaT 013

MaaT013 is a standardized, high-richness, high-diversity Microbiome Ecosystem TherapyTM containing ButycoreTM (group of bacterial genera known to produce immuno-regulatory metabolites). It aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and reduce steroid-resistant, gastrointestinal-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). MaaT013 is an off-the-shelf, healthy-multi-donors-derived product intended for acute, hospital use. Currently the drug is in Phase III stage of development for the treatment of Graft-versus-host disease.

2. Company Overview: Qu Biologics

Qu Biologics is a clinical stage biotechnology company developing Site Specific Immunomodulators (SSI), a novel class of immunotherapies designed to stimulate an innate immune response in targeted organs to reverse the immune dysregulation underlying many important diseases including cancer, inflammatory bowel disease, infection, and inflammatory lung diseases. Qu has completed four Phase 2 studies in lung cancer, Crohn’s disease, and ulcerative colitis. Qu’s 5th Phase 2 study is underway in early-stage colon cancer, with two additional upcoming Phase II randomized placebo-controlled studies in late-stage colon cancer and immunosenescence.

Product Description: QBKPN

QBKPN SSI, a first-in-class immune modulator designed to optimize immunity and barrier function in the lungs. The clinical trial is designed to assess QBKPN’s effectiveness in restoring innate immunity, the prevention of serious morbidity and mortality from respiratory infections, including COVID-19 and its variants, and reduction in all-cause mortality. QBKPN SSI is designed to restore and enhance innate immune function, the body’s first line of defense against all infections and other diseases such as cancer. Currently the drug is in Phase II stage of development for the treatment of immunodeficiency disorders.

3. Company Overview: Enterome

Enterome is a clinical-stage biopharmaceutical company developing breakthrough immunomodulatory drugs for the treatment of cancer and immune diseases. Enterome’s pioneering approach to drug discovery is based on its unique and powerful bacterial Mimicry drug discovery platform, allowing it to analyze and uncover new biological insights from the millions of gut bacterial proteins in constant cross-talk with the human body. Its first-in-class, small protein and peptide drug candidates modulate the immune system by closely mimicking the structure, effect or actions of specific antigens, hormones, or cytokines

Product Description: EO2040

EO2040 is an innovative, off-the-shelf immunotherapy that combines two synthetic OncoMimics™ peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the tumor-associated antigens (TAAs) FOXM1 & BIRC5. EO2040 also includes universal cancer peptide 2 (UCP2), a helper peptide representing the CD4+ epitope. The drug is currently in Phase II stage of development for the treatment of patients with colorectal cancer.

4. Company Overview: Biomica Ltd.

Biomica is a clinical stage biopharmaceutical company developing innovative microbiome-based therapeutics utilizing PRISM system, a proprietary computational platform powered by Evogene’s MicroBoost AI tech-engine licensed from Evogene. Biomica aims to identify and characterize disease-related microbiome entities and to develop novel therapeutics based on these understandings. The company is focused on the development of therapies for antibiotic resistant bacteria, immuno-oncology, and microbiome-related gastrointestinal (GI) disorders. Biomica is a subsidiary of Evogene Ltd.

Product Description: BMC128

BMC128 is a rationally-designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene’s MicroBoost AI platform. Developed as a Live Bacterial Product (LBP), BMC128 is an LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbour specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes. Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria. The drug is currently in Phase I stage of development for the treatment of patients with colorectal cancer.

5. Company Overview: Seres Therapeutics

Seres Therapeutics, Inc. is a commercial-stage company developing novel microbiome therapeutics for serious diseases. Seres’ lead program, VOWST™, obtained U.S. FDA approval in April 2023 as the first orally administered microbiome therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI and is being commercialized in collaboration with Nestlé Health Science. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation. 

Product Description: SER-155

SER-155 is a consortium of bacterial species selected using Seres’ reverse translation discovery and development MbTx platform technologies. The design incorporates microbiome biomarker data from human clinical data and nonclinical human cell-based assays, and in vivo disease models. The SER-155 composition is designed to prevent and decrease the colonization and abundance of bacterial pathogens that can harbor antibiotic resistance and to enhance epithelial barrier integrity in the GI tract to both reduce the likelihood of pathogen translocation and decrease the incidence of bloodstream infections and GvHD. SER-155 has received FDA Fast Track Designation. The drug is currently in Phase I stage of development for the treatment of patients with Bacteraemia.

6. Company Overview: Micro Viable Therapeutics

MatriSys Bioscience is leading the discovery Microviable Therapeutics SL, spun out from the Spanish National Research Council in 2016, focused on developing novel technologies and therapeutic products from the microbiota. Over the last years, Microviable lunched a disruptive product for microbiota sampling that has grown exponentially into an international market with clients across fifteen different countries. Moreover, it has developed a unique technology to store human microbiota for downstream therapeutic applications. Currently, Microviable’s platform together with its large and diverse proprietary bacterial culture collection, has enabled the development of two different products, a unique in its kind product of complete microbiota and rationally defined bacterial consortia.

Product Description: MSB-0221

MVT-201, is an orally administered capsule generated under cGMP conditions representing the complete gut microbiota of a clinically validated healthy donor and will get into the clinical trials in 2024 for undisclosed targets. The lead product, MVT-201, is under evaluation at pre-clinical stage with positive results, and it is a unique in its kind biological drug based on complete microbiota (HiPMTM) for undisclosed targets. The microbiota-derived product development platform also includes rationally design and defined bacterial consortia that will be advanced with this funding. This investment will enable to consolidate Microviable’s growth and focus towards the therapeutics, while increasing their facilities and headcount.

Further product details are provided in the report……..

Microbiome Analytical Perspective by DelveInsight

• 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

• 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?