COMMENSE (Microbiome-Derived Immune Modulators (Pediatric))

(COM101)

Immune System

TRIAL PHASE
AFFILIATEFOCUSPRTC
OWNERSHIP
PRECLINICALPHASE 1PHASE 2PHASE 3/
PIVOTAL
FILING
Commense
Microbiome-Derived Modulators for Pediatric and Maternal Immune Disease
90.0%

Immune System

Commense
Microbiome-Derived Modulators for Pediatric and Maternal Immune Disease
90.0%
Preclinical
Microbiome-Derived Immune Modulators (Pediatric)

 

Our affiliate Commense is developing interventions for pediatric and maternal health based on a deep understanding of the early life microbiome. Nurturing a healthy microbiome early in life represents a novel strategy to significantly reduce the impact of many diseases in children including asthma, allergies, diabetes, and obesity.

The first 100 days – and up to one year – of life are critical periods in the development of a baby’s immune system. The gut holds the most immune tissue in the human body as well as the most bacteria by weight. It is therefore not a coincidence that the cross-talk that occurs between microbial cells and human immune cells serves as the foundation for the development of immune tolerance. Early exposure to a wide range of bacteria educates and primes the developing immune system towards health. Perturbances such as lack of exposure to beneficial bacteria due to antibiotic use, delivery mode (e.g., caesarean vs. natural), environment, diet, and feeding method, etc., can cause a bias in the gut community towards dysbiotic bacteria, thereby skewing the immune system towards disease. 

Drawing insights from natural exposure to beneficial microbes, we are developing rationally-defined bacterial consortia as therapeutics to potentially address critical unmet needs in pediatric populations. These live biotherapeutic products (LBPs) are based on a deep understanding of human-microbe interactions, the effects of microbes on the immune system, and the impact of these interactions on maternal and infant health.

  • 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, children are being affected earlier in life with devastating long-term impacts on families and health systems.
    • Several emerging lines of evidence suggest that alterations in the early life microbiome increases risk for diseases, including asthma, allergies, eczema, necrotising enterocolitis, Type 1 diabetes, Type 2 diabetes, and obesity. These harmful alterations have been linked to changes in the maternal microbiome, birth mode (e.g., caesarean vs natural), exposure to antibiotics, formula-feeding (vs breastmilk-feeding), and other environmental factors such as being raised in an urbanized environment as opposed to growing up on a farm. Recently, and consistent with these lines of evidence, a publication demonstrated that the prospective administration of a microbe could prevent death and sepsis in new borns.
    • Our approach to address unmet needs in the pediatric population revolves around the understanding of 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.
  • Our Approach to Solving the Problem
    • We are developing COM-101, which aims to replenish four microbes causally demonstrated to protect against the development of atopy and wheeze at 12 months – a risk factor in the diagnosis of atopic dermatitis and asthma at school age.
  • Intellectual Property
    • We have broad intellectual property coverage worldwide, including exclusive rights to 16 patent applications in 6 families of patent filings.
    • Our patent portfolio covers a range of compositions and therapeutic uses of products containing microbiome bacteria for use in diagnosing and treating various conditions, including gut dysbiosis, asthma, allergy, and atopy, as well as other conditions.
  • Team
    • Edward J “Tad” Stewart is CEO of Commense. Along with Mr. Stewart, the operations team includes Dr. Lily Ting, Dr. Aleks Radovic-Moreno, Mr. Skip Farinha, and Ms. LuAnn Sabounjian.

    • Advisory board members comprise of Dr. Maria Gloria Dominguez-Bello (Rutgers and inventor of a key technology exclusively licensed by Commense); Dr. B. Brett Finlay (University of British Columbia and inventor of a key technology exclusively licensed by Commense), Dr. Martin Blaser (New York University), Dr Rob Knight (University of California, San Diego), and Dr. Joe St. Geme (Children’s Hospital of Philadelphia).

  • Milestones Achieved
    • We have initiated preclinical studies for COM-101 based on the technology licensed from the lab of Dr. B. Brett Finlay at the University of British Columbia, Canada, in 2017. The license covers several strains of bacteria with potential application in pediatric allergy and respiratory disease.
    • We have built a clinical advisory team specific to COM-101. Its advisors are experts in pediatric pulmonology, pediatric respiratory clinical trials, and pediatric drug regulatory affairs.
    • Work on a clinical strain library has also begun. This library will serve as a master cell bank for pipeline assets.
    • We developed a VMT (vaginal microbial transfer) clinical kit and a companion smartphone app for HIPAA compliant data collection. The kit and app serve as the foundation for clinical collaborations between Commense and clinical researchers performing longitudinal infant studies.
    • Recruitment has begun for the first randomized controlled clinical trial with Inova in Virginia using the clinical trial kit and app.
    • We launched lab operations. In-house capabilities include anaerobic microbiology, biobanking, biochemistry, and molecular biology. Relationships with external CROs expand capabilities to include gnotobiotic mouse facilities and microbiome sequencing (16S and metagenomics).
    • We have initiated preclinical studies to explore the role of VMT in immune and metabolic phenotypes.
  • Expected Milestones and Timing
    • We expect to begin manufacturing activities for COM-101 in 2018 and plan to initiate human clinical studies in 2019.

Drawing insights from natural exposure to beneficial microbes, we are developing rationally-defined bacterial consortia as therapeutics to potentially address critical unmet needs in pediatric populations. These live biotherapeutic products (LBPs) are based on a deep understanding of human-microbe interactions, the effects of microbes on the immune system, and the impact of these interactions on maternal and infant health.


Guiding the Developing Microbiome


CS-004: Commensal consortia for the prevention/treatment of atopic march (asthma/allergy/atopic wheeze)