Microbiome-Derived Immune Modulators (Pediatric)

(COM101)

Immune System

TRIAL PHASE
MECHANISMINDICATION(S)PRODUCT NAMEPreclinicalPhase 1Phase 2Phase 3
Microbiome-Derived Immune Modulators (Pediatric)
Asthma, Allergy and other Pediatric Autoimmune Disorders
Commense
(COM101)

Immune System

Microbiome-Derived Immune Modulators (Pediatric)
INDICATION(S):Asthma, Allergy and other Pediatric Autoimmune Disorders
NAME:Commense (COM101)
STAGE:Preclinical
Microbiome-Derived Immune Modulators (Pediatric)

Nurturing a healthy microbiome early in life represents a novel strategy to significantly reduce the impact of diseases such as asthma, diabetes, obesity, and allergies in children. We are developing interventions for maternal and pediatric health based on a deep understanding of the early life microbiome.

Drawing insights from natural exposures to beneficial microbes, we are developing rationally defined consortia of bacteria as therapeutics to address critical unmet needs in pediatric populations.

 

  • Patient Need & Market Potential
    • In the developed world, the incidence and prevalence of numerous immune and metabolic diseases affecting children is on the rise. Furthermore, these children are being affected earlier and earlier in life with devastating long-term impact on families and health systems
    • Several emerging lines of evidence suggest that these diseases, including asthma, allergies, eczema, necrotizing enterocolitis, Type 1 diabetes, Type 2 diabetes and obesity, may be caused by alterations to the early microbiome. These harmful alterations have been linked to changes to the maternal microbiome, birth mode, exposure to antibiotics, formula-feeding (as opposed to breastmilk-feeding), and the environment, for example being raised in an urbanized environment as opposed to growing up on a farm
    • We are developing novel, live biotherapeutics (LBPs) based on a deep understanding of human/microbe interactions and the impact on maternal and infant health
  • Our Approach to Solving the Problem
    • Our approach for addressing unmet needs in the pediatric population revolves around understanding how, and in what context, microbes impact maternal and early childhood health. For example, we are exploring the role that maternal microbes play in gestation, at birth, and in infant health in the first year of life
  • Intellectual Property
    • We have broad worldwide intellectual property coverage, including exclusive rights to four issued patents and several patent applications on composition of matter, novel formulations and methods
    • We also have pending patent filings on both our maternal microbial intervention and the associated microbes
  • Team
    • Our team has strong expertise in technology translation, microbiology, and pediatric clinical care 
    • Key advisors include:

      Dr. Martin Blaser, Professor of Translational Medicine and Director of the Human Microbiome Program at New York University;

      Dr. Rob Knight, Professor of Pediatrics and Computer Science and Engineering at the University of California, San Diego, and author of "Follow Your Gut: The Enormous Impact of Tiny Microbes";  

      Dr. Maria Gloria Dominguez-Bello, Associate Professor in the Division of Translational Medicine in the Department of Medicine at the New York University Langone Medical Center, Fellow at the Infectious Disease Society of America and Fellow at the American Academy of Microbiology;

      Dr. Brett Finlay, Professor in the Michael Smith Laboratories, the Departments of Biochemistry and Molecular Biology, and Microbiology and Immunology at the University of British Columbia;

      Dr. Joe St. Geme, Physician-in-Chief and Chairman of the Department of Pediatrics at the Children’s Hospital of Philadelphia (CHOP) and the Chairman of the Department of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania;

      Mr. Sam Kass, former Executive Director of Michelle Obama’s “Let’s Move!” campaign and Senior Policy Advisor for Nutrition and Chef at the White House.
    • Our team includes Dr. James Mutamba, Dr. Aleks Radovic-Moreno, Mr. David Steinberg, Dr. Lily Ting, Mr. Skip Farinha and Ms. LuAnn Sabounjian
  • Milestones Achieved
    • We secured a licensing agreement with the University of British Columbia for a microbiome-based therapy directed toward halting the development of asthma, allergy and other autoimmune diseases that present themselves in childhood. This live biotherapeutic product is being developed as a novel therapeutic to nurture a healthy microbiome early in life. Based on research by Dr. Brett Finlay at the University of British Columbia, this work has been published in Science Translational Medicine [See publications]
    • We obtained an exclusive, worldwide license from New York University for a key building block of our platform – an approach focused on replenishing and bolstering the microbial exposure that a baby experiences at birth during passage through the birth canal. This technology is designed to enable microbial transfer in newborns who may not receive the vaginal microbiome, including those delivered by caesarian section (C-section). The work supporting this technology is from a key advisor, Maria Gloria Dominguez-Bello, Ph.D., Associate Professor of Medicine at NYU Langone Medical Center, and was published in the February 1, 2016 issue of Nature Medicine [See publications]
    • We have initiated preclinical studies to explore the role of vaginal microbial transfer (VMT) in immune and metabolic disease phenotypes 
    • We have also initiated the manufacturing of a VMT Procedure Kit for clinical trials and data collection
  • Expected Milestones and Timing
    • The Microbiome-Derived Immune Modulators – Pediatric program is expected to begin clinical studies in 2019

The first 100 days of life and up to one year are critical periods in a baby’s immune system development (Bokulich et al. 2016). The gut holds the most immune tissue in the human body as well as the most bacteria by weight. It is not a coincidence therefore that the cross-talk that occurs between microbial cells and human immune cells serves as the foundation to the development of immune tolerance. Perturbances such as lack of exposure to beneficial bacteria due to antibiotics exposure, delivery mode, environment, diet and feeding method, etc., can cause a bias in the gut community towards dysbiotic bacteria and skew the immune system towards disease (For example see Dominguez-Bello et al., 2010).


Guiding the Developing Microbiome