Science & Innovation

Unlock the Healing Potential of the Microbiome

Yemi Adesokan leading a science innovation meeting Yemi Adesokan leading a science innovation meeting.

Microbiome basics

Our microbiome consists of billions of microbes most of which are found in our intestine. It sends messages throughout our bodies that are essential for our health and wellbeing.

The microbiome is possibly our most fragile organ, easily disrupted and damaged. A damaged microbiome can lead to common symptoms we have all experienced, such as bloating, diarrhea, or worse, chronic inflammation to name a few.

While there has been a scientific revolution in understanding the microbiome and the role it plays in our daily health, there has been little progress in finding solutions which repair and heal an imbalanced microbiome.

Nature provides a solution to develop and form the microbiome in infants, puppies and kittens through complex glycans found in breast milk. Gnubiotics has been able to mimic nature’s magic and healing abilities to maintain and restore the microbiome.

“There has been little progress in finding solutions which repair and heal an imbalanced microbiome”

Gnubiotics products

Unique diversity of glycans in Gnubiotics products.

A breakthrough in replicating nature’s magic

Gnubiotics was founded to apply a unique scientific understanding that nature is a reservoir of diverse glycans endowed with the potential to restore, renew and repair the microbiome.

We have developed the ability to recreate the unique diversity of glycan structures found in breast milk, nature’s perfect food.

From this foundational understanding, Gnubiotics has applied its proprietary technology to develop a broadening pipeline of product candidates. Our pipeline candidates are designed to mimic the complex glycan structures found in the breast milk of cats, dogs and humans with the goal of forming, maintaining and restoring microbiome health for life.

A unique technology platform

Gnubiotics’ technology platform has excelled beyond product development and analytical capabilities to produce its natural glycan-based products at multi-ton scale. Our first-in-class technology platform is anchored on three pillars:

Analytics Analytics

Develop and design products based on unparalleled analytical capabilities and precision.

Development Efficacy

Track product efficacy using ultra-high-resolution sequencing technologies within the framework of robust clinical studies.

Industrialization

Industrialize production of glycans at the highest quality standards.

The Gnubiotics platform enables us to bring an unrivalled source of natural, diverse and scientifically proven glycans into functional microbiome-centric products at industrial scale that target unmet needs in multiple conditions and diseases.

Scientific approach

Gnubiotics advances its candidates through an efficient stage-gate pathway that de-risks and optimizes the pipeline. Our pipeline candidates are initially developed under the food regulation that enables a rapid path to first-in-human clinical studies. Therapeutic candidates are then developed further following drug regulations.

Gnubiotics will soon be starting preclinical trials of its first products designed for human therapeutic applications.

Sourcing process

1
In-Vitro

  • Growth of desirable bacteria
  • No growth of pathogens

2
Safety

  • Genotoxicity battery
  • Sub-chronic study

3
Ex-Vivo

  • Microbiome diversity
  • Positive microbial response
  • Metabolite production

4
Animal Models

  • Microbiota modulation
  • Efficacy markers

Industrialization
5
Clinical Studies

  • Safety & Tolerability
  • Microbiota structure & function
  • Efficacy markers

6
Outcome

  • Evidence of safety, quality and efficacy.

Products & Pipeline Candidates

The desire to enable a precise modulation of the microbiome with specific clinical benefits has stimulated our development of product candidates based on an ensemble of diverse and complex glycans that precisely and safely heal the microbiome.

Our candidates are novel, innovative and uniquely positioned to succeed as they:

  • demonstrate utmost precision in their mode of actions by using a natural reservoir of safe, efficacious and extraordinary diverse glycans
  • are available at or readily amenable to industrial scale thanks to our established manufacturing capabilities and sustainable supply chain
  • target the resident microbiome as opposed to adding foreign bacteria, thus resulting in a safer, more robust modulation.

Our Pipeline:

Candidates & Indications
Discovery
Pre-clinical
Efficacy
Market
Collaborator
Companion Animal - Nutrition
Companion Animal - Health
Human - Supportive Care
GNUbiome FI

ℹ Companion Animal Nutrition


Canine & Feline
GNUbiome FI

ℹ Post-antibiotic microbiome recovery


Canine & Feline
GNUbiome FI

Inflammatory Bowel Disease


Canine
GCX/GBX

ℹ AMR infection


CRE, ESBL, VRE, MDR P. aeruginosa
GCX/GBX

ℹ Inflammatory & Metabolic


IBD
GCX/GBX

ℹ Immuno-oncology


Colorectal cancer
GCX/GBX

ℹ Immuno-oncology


Melanoma
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PRODUCT CANDIDATE OVERVIEW

GNUbiome FI is a functional nutritional ingredient intended to establish and support the microbiome of dogs and cats, thus helping strengthening the immune system and strengthen the gut barrier. GNUbiome FI contains a mix of AMO biosimilars delivering all their benefits to the pets.

PROGRESS

GNUbiome FI is available on different markets. GNUbiome FI has been demonstrated palatable, safe and well-tolerated, and efficacious in beneficially shifting the fecal microbiota. Genotoxicity and 6-month long animal studies support the safety of GNUbiome FI for the inclusion in canine and feline diets.

UNMET NEED

Mimicking the diversity and complexity of AMO is critical, as the diverse benefits of AMO are almost certainly related to their structural and functional diversity, with multiple components acting together to promote health. However, current substitutes are limited either in structural complexity or in diversity, not to mention the challenge of large-scale supply.

MODE OF ACTION

Like AMOs, GNUbiome FI fortifies the microbiome in three key functional areas: (i) support growth of essential bacteria, (ii) control undesirable bacteria and (iii) promote metabolites essential for strengthening the gut lining, reducing inflammation and ensuring optimum immune system function.

×

PRODUCT CANDIDATE OVERVIEW

GNUbiome FI is a functional nutritional ingredient intended to establish and support the microbiome of dogs and cats, thus helping strengthening the immune system and strengthen the gut barrier. GNUbiome FI contains a mix of AMO biosimilars delivering all their benefits to the pets.

PROGRESS

GNUbiome FI is being tested in a clinical study to determine how GNUbiome FI impacts the fecal characteristics, microbiota, and bile acids of adult dogs treated with antibiotics.

UNMET NEED

Antibiotics are frequently used to treat bacterial infections in animals. However, antibiotics can cause unhealthy long-term changes in the microbiome and can present side effects such as Vomiting and diarrhoea. Solutions are needed to mitigate such side effects

MODE OF ACTION

GNUbiome FI fortifies the microbiome and helps restoring its diversity, thus GNUbiome-supplemented animals will have fewer changes to fecal characteristics, microbiota, and metabolites after antibiotic administration.

×

PRODUCT CANDIDATE OVERVIEW

GCX and GBX are product candidates intended to be orally administered to modulate the microbiome, activate metabolites and exert selective antimicrobial as well as immunomodulatory effects in humans. GCX and GBX contains a mix of tens of MO biosimilars in the form of glycopeptides.

PROGRESS

GCX and GBX are being tested in collaboration with NIAID in a pre-clinical program to demonstrate safety and efficacy against multi-drug resistant bacteria in a set of IND-enabling studies.

UNMET NEED

CRE, ESBL, VRE and MDR P. aeruginosa are all recognized as urgent and serious antibiotic resistance threats by the US CDC. CRE, ESBL and VRE are major concerns for patients in healthcare facilities and the community with about 15’000 deaths in 2017 in US alone. MDR P. aeruginosa is particularly dangerous for patients with chronic lung diseases and resulted in about 3’000 deaths in 2017 in US. Colonization of the intestine by these bacteria often preceded systemic infection. Unfortunately, antibiotics often increases susceptibility to infections by disrupting the protective microbiome.

MODE OF ACTION

GCX and GBX fortify the microbiome by favouring the growth of commensal bacteria and helps restoring its diversity and activity, thus GCX and GBX aim to reduce colonization by pathogenic bacteria and support the maintenance of the intestinal barrier, limiting subsequent systemic infection.

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PRODUCT CANDIDATE OVERVIEW

GCX and GBX are product candidates intended to be orally administered to modulate the microbiome, activate metabolites and exert selective antimicrobial as well as immunomodulatory effects in humans. GCX and GBX contains a mix of tens of MO biosimilars in the form of glycopeptides.

PROGRESS

GCX and GBX are being tested in collaboration with University of Zürich (Switzerland) in mice models to demonstrate that they can act as anti-inflammatory agents to treat chronic inflammatory diseases, such as inflammatory bowel disease (IBD).

UNMET NEED

Inflammatory bowel diseases (IBDs) are chronic, relapsing inflammatory disorders of the intestinal tract and potentially causing a life-long burden and reduction of quality of life for the patients. Worldwide, over 2.5 million people of European ancestry are affected. Due to the associated severe morbidity and unsatisfactory treatment options available, research on IBD pathogenesis is currently intense. It becomes apparent that a dysbalance of the entire intestinal flora leads to an activation of the immune system that can cause the disease.

MODE OF ACTION

GCX and GBX fortify the microbiome and help restoring its protective activity, thus GCX and GBX aim to restore the epithelial barrier and exert immunoregulatory function.

×

PRODUCT CANDIDATE OVERVIEW

GCX and GBX are product candidates intended to be orally administered to modulate the microbiome, activate metabolites and exert selective antimicrobial as well as immunomodulatory effects in humans. GCX and GBX contains a mix of tens of MO biosimilars in the form of glycopeptides.

PROGRESS

GCX and GBX are being tested in collaboration with University of Zürich (Switzerland) in mice models to demonstrate that they can control tumor growth alone or in enhancing the efficacy of immune-checkpoint inhibitors (ICIs).

UNMET NEED

Colorectal cancer (CRC) is the second leading cause of cancer-related death worldwide while melanoma remains one of the most aggressive tumor types, with propensity to resist therapy. Despite immune checkpoint inhibitors (ICI) have revolutionized the treatment of some cancers, response rates remain low and differ between patients. Non-responding patients have very few alternative treatments, impacting survival rate. The microbiota has shown promises in controlling tumor growth and in modulating anti-tumor immunity and thus efficacy of ICI therapy. Solutions for prolonging quality and fulfilling lives resides in our ability to leverage the microbiome to help to provide sustainable, long-term control of the disease.

MODE OF ACTION

A high microbiome diversity is now recognized as an essential asset in immunotherapy treatment response. GCX and GBX fortify the microbiome and selectively grow specific bacterial commensals found to be more abundant in the gut of patients responding to immunotherapies, thus GCX and GBX aim to safely alter the microbiome to control tumor growth and improve treatment response.

Gnubiotics products

Patent Filings

Gnubiotics has two patents issued and an additional thirteen patent filings under review and pending.

Please contact Gnubiotics for more information.

Scientific publications & References

Our product candidates are supported by scientific publications involving members of the Gnubiotics team and by third-party evidence.


Companion animal

Microbiome modulation & detection in humans

Complex Glycans: Support the microbiome & fight infectious diseases

Complex Glycans: An opportunity to fight cancer

Complex Glycans: Maintain gut immunity

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