our model

Scaled Microbiomics’ Worldview and Strategy:

Scaled Microbiomics has precision technology to target specific pathobionts which cause and contribute to the disease cascade.

  • Microbiomes are being recognized as “new organs” interacting with and providing essential function to the whole organism.
Horizontal shot of two unrecognizable scientists wearing white coats gloves working in laboratory using modern computers

Scaled Microbiomics’ Worldview and Strategy:

Scaled Microbiomics has precision technology to target specific pathobionts which cause and contribute to the disease cascade.

  • Microbiomes are being recognized as “new organs” interacting with and providing essential function to the whole organism.

Microbiomes are being recognized as “new organs” interacting with and providing essential function to the whole organism.

As with other organs, the cells constituting a microbiome engage in intra- and inter-cellular communications as well as in signaling cascades with other tissues and organs

These pathways and cascades are rapidly becoming evident, providing rational points of intervention by removal/blocking/inhibition of key organisms/molecules involved in dysbiosisdriven pathogenesis

Very recent studies have affirmed that selective inhibition of such pathways in a model of colorectal cancer alters pathological phenotypic expression

As with other organs, the cells constituting a microbiome engage in intra- and inter-cellular communications as well as in signaling cascades with other tissues and organs

These pathways and cascades are rapidly becoming evident, providing rational points of intervention by removal/blocking/inhibition of key organisms/molecules involved in dysbiosisdriven pathogenesis

Very recent studies have affirmed that selective inhibition of such pathways in a model of colorectal cancer alters pathological phenotypic expression

Antibody Technology

Antibody technology has proved invaluable in scientific discovery, detection, and therapeutic interventions within and between traditional organs and organ systems, permitting precise modulation.

SMB proposes that antibody technology holds similar potential in manipulation of microbiome physiology and organ-host interactions, expanding the field of Subtractive Microbiome Therapeutics and diagnostic modalities associated with it, to achieve true editing of microbiome structure and function.

This approach invents a new branch of microbiome therapeutics and diagnostics, and provides countless opportunities to develop new drugs, formulations, diagnostic and screening technologies at low cost.

Challenges to Developing Antibody-Based Microbiome Subtractive Therapeutics

Production Level

SMB anticipates that large (mg/dose) quantities of antibody will not be required to address intra-microbiome processes; traditional Ab therapies are prohibitively costly for this application.

Target-specificity

SMB recognizes the complexity and interrelatedness of microorganisms and their signaling molecules in a functioning microbiome; SMB is working to express strain-specific functional antigens for each target microorganism and signaling molecule.

Regulatory Matters

A regulatory pathway must be established for microbiome-targeted antibody formulations; FDA and EMA (and others) currently approve of multiple polyclonal applications of antimicrobial antibodies (e.g., tetanus/rabies immune globulins, various IVIG and SQIG formulations).

Challenges to Developing Antibody-Based Microbiome Subtractive Therapeutics

Production Level

SMB anticipates that large (mg/dose) quantities of antibody will not be required to address intra-microbiome processes; traditional Ab therapies are prohibitively costly for this application.

Target-specificity

SMB recognizes the complexity and interrelatedness of microorganisms and their signaling molecules in a functioning microbiome; SMB is working to express strain-specific functional antigens for each target microorganism and signaling molecule.

Regulatory Matters

A regulatory pathway must be established for microbiome-targeted antibody formulations; FDA and EMA (and others) currently approve of multiple polyclonal applications of antimicrobial antibodies (e.g., tetanus/rabies immune globulins, various IVIG and SQIG formulations).

SMB’s Selected Antibody Scaffold: Avian Immunoglobulins (IgY)

IgY is produced abundantly in eggs of immunized hens (100 mg/yolk)

Scientist is examining

Extraction & Purification

Extraction and purification costs vary with degree of purity demanded; simple dried hyperimmune egg yolks have promise for use in dietary supplements/DTC market, PEG extraction to 95% purity is practical for initial drug development

GRAS

IgY is Generally Recognized as Safe (GRAS)

SMB’s Selected Antibody Scaffold: Avian Immunoglobulins (IgY)

IgY is produced abundantly in eggs of immunized hens (100 mg/yolk)

Scientist is examining

Extraction & Purification

Extraction and purification costs vary with degree of purity demanded; simple dried hyperimmune egg yolks have promise for use in dietary supplements/DTC market, PEG extraction to 95% purity is practical for initial drug development

GRAS

IgY is Generally Recognized as Safe (GRAS)

IgY structure precludes activation of host innate immune (complement-driven) reactions

IgY scaffold is amenable to modifications including humanization, nanobody production, specialized multi-valent antibodies – as readily as Abs from other species

Production of first-run drug candidates with IgY is disruptively fast and inexpensive; each drug candidate is a diagnostic candidate, extending value of development investment

Taken together, SMB believes that IgY antibodies represent an ideal drug discovery platform for fast, inexpensive development of dysbiosis-targeted microbiome therapeutics and diagnostics. The field is wide open and will be poised for growth as studies of microbiome dynamics reach increasing levels of resolution, identifying ever-broadening ranges of druggable targets and opportunities for detection and screening.

SMB Funnel Diagram General

SMB’s Business Model is a drug discovery platform enabling drug candidates to reach preclinical testing in less than 1 year at fractional cost compared with existing drug discovery strategies.

Join the reEvolution

Growth. Innovation. Discovery.

Join the reEvolution

Growth. Innovation. Discovery.