AGS-TX

2-billion-year-old

technology, unleashed.

AGS THERAPEUTICS

We engineer the billion-years-old natural machinery of microalgae to develop therapeutics delivered by microalgae extracellular vesicles (mEVs).

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AGS-TX

Technology Platform

Our highly versatile, proprietary technology platform can be applied to a diversity of targets and purposes. As part of our initial focus on anti-infectives, we develop microalgae-induced gene silencing therapeutics, delivered by microalgae extracellular vesicles, aimed at killing or blocking the replication of human pathogens.

MIGs Platform

Microalgae Genetic Engineering

Our proprietary platform enables the generation of stable producer cell lines from genetically engineered microalgae, for therapeutics applications. The microalgae are then used to express custom, targeted RNAi (siRNA or miRNA) which are directly embedded, by the same microalgae, into their own extracellular vesicles.

RNAi Biotherapeutics

Antimicrobial Precision Killing

The therapeutic agents (RNAi) produced by our initial set of microalgae cell lines are designed to be pathogen-killers independent of their antibiotic resistance (bacteria) and their immunogenicity or escape mutability (viruses). Welcome the next generation of antibacterial and antiviral biotherapeutics.

RNAi targets

Gene Silencing Shotgun

We take advantage of the versatility of RNAi, used to down-regulate the expression of target genes in specific hand-picked gene sequences, and aim at any and all regions, both structural and functional, where essential, pathogenic, or resistance genes are present.
All the action happens simultaneously, like a shotgun.

MEVs

Natures’ own Delivery System

True to EVs’ natural role as primary communication channel between cells, we engineered our microalgae-based EVs (MEVs) to serve as Drug Delivery System (DDS), to carry, protect, and deliver their cargo right into human or bacterial cells. By design, MEVs can be either generic (targeting a variety of tissues and allowing for multiple administration routes) or specific.

Safe system

The Ideal Biological System

Microalgae are free from human pathogens (e.g. viruses, mycoplasma), and their MEVs are non-toxic as well as non-immunogenic for humans. Unlike most of the current pharmaceutical industry, which uses animal cells or synthetic biology for the manufacturing of proteins, viral vectors, and EVs among others, our technology offers a safer alternative.

Simple process

The New Gold Standard

Requiring only light, water, and salts, microalgae-based biologics are produced and purified using inherently clean and simple processes, with low-to-no media supplements, that can easily be scaled-up in compliance with cGMP regulations. Equipped with cutting-edge Photo-Bioreactors (PBRs) and industry-standard Downstream Processing (DSP) tools, we achieve a high-yield, low-cost overall process.

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Science and Technology

AGS Tx

Extracellular Vesicles from Microalgae (MEVs) as Delivery Systems for Human Therapeutics
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Unmet needs to be addressed by DDS

The ideal DDS must be able to deliver therapeutic molecules specifically to the site of treatment, avoid premature degradation or inactivation of the therapeutic agent by the immune system or by enzymes, and reliably release the molecules transported.

The treatment of a large number of human diseases remain elusive due, among other, to our inability to deliver therapeutic doses of drugs to the right target place in the body, without affecting other organs or tissues. The lack of performing drug delivery systems (DDS) is a significant bottleneck, and a major unmet need for many diseases, for some of which the therapeutic agent even exists but cannot be properly delivered.

The principle of vectorization generally consists of “encapsulating” the therapeutic molecule within a vector to protect it, transport it, and deliver it more efficiently to the body's target site.

Major technical and unresolved bottlenecks directly related to DDS are: (1) routes of administration, (2) delivery vehicles (or vectors), (3) type of therapeutic molecule, (4) mode of loading, (5) targeting strategies.
Major challenges are: (1) the passage of the blood-brain barrier (BBB), (2) the lack of oral availability, (3) the profile of the vectors (stability, non-toxicity, non-immunogenicity) and (4) the manufacturing capacity and scalability.

Microalgal Extracellular Vesicles can be loaded with relevant biological cargos (RNAs/DNAs, and other). MEVs have shown have striking properties in terms of biodistribution (brain penetration by the nose (thus overcoming the BBB), and oral delivery), and they show reduced clearance rates compared to other DDS including mammalian EVs. Finally, MEV manufacturing is easily scalable.

Our Science

MEVs (Microalgae Extracellular Vesicles) as a Universal Delivery System and Non-viral Gene Therapy Vector

As all extracellular vesicles, MEVs have naturally evolved to efficiently pass genetic material and other kinds of molecules from cell to cell. They orchestrate intercellular and cross-kingdom communication between cells via exchange of biologically active molecules.

MEVs are Natural nanoparticles, cell-derived (no synthetic components) and intrinsically safe (non-toxic in animalsno risk of endogenous virus potentially dangerous to humans).

AGS uses Chlorella vulgaris, a freshwater microalgae, to produce its MEVs. Chlorella is a unicellular haploid alga that is a natural and efficient producer of extracellular vesicles.

Chlorella vulgaris has been consumed worldwide as a food supplement for decades. It is non-toxic and non-immunogenic, and can be cultured at large industrial scale at low cost.

Extracellular Vesicle from Microalgae (MEV)

AGS’ MEVs from Chlorella vulgaris can be directly used to protect, convey, and deliver a broad spectrum of innovative therapeutic molecules into target cells relevant to specific diseases.

Native MEV share several relevant common features:

(1)
the biodistribution patterns by route of administration, 
(2)
the toxicity profile by route of administration,
(3)
the pharmacokinetics profiles in vivo,
(4)
the behavior through the downstream processing, and 
(5)
the product specifications related to the outside of the MEV.

Native MEVs have striking properties in terms of:

.
Administration: they can alternatively be administered per os, to the respiratory tract, intranasally, intravenously, among other routes.
.
Biodistribution: they convey the payload to a small set of specific organs according to the route of administration, such as the intestine, the GALT, the spleen, the lungs, the liver, and to specific structures in the brain. 
.
Clearance rates: they last in the target organs longer than reported for other delivery systems including mammalian EV.
.
They efficiently by-pass natural body barriers, such as the gastro-intestinal barrier and the blood-brain barrier ; an objective so far unattainable by most LNPs or EV from mammalian origin.

AGS has demonstrated the capacity of MEV to efficiently overcome natural body barriers (such as oral delivery, or specific lymphoid tissues delivery, or nose-to-brain delivery) which have been so far unattainable by most LNPs or EV from mammalian origin.

Unmet needs to be addressed by drug delivery systems

Unmet needs to be addressed by DDS

The treatment of many human diseases remains elusive due, among other, to our inability to deliver therapeutic agents, to the right cell target in the body and in biologically active amounts, without affecting other cells or tissues.

Drug delivery systems are expected to be able to convey and reliably deliver therapeutic molecules specifically to the site of treatment, while avoiding premature degradation or inactivation of the therapeutic agent by the immune system or by enzymes.

The lack of performing drug delivery systems is a significant bottleneck, and a major unmet need for many diseases, for some of which the therapeutic agent already exists but cannot be properly delivered.

Major unresolved issues related to DDS are:

(1)
the routes of administration and the natural biological barriers in the body (such as the stringency of the digestive tract, the brain-blood barrier, or the immune system),
(2)
the effective targeting of specific cells or tissues, and
(3)
the effective targeting of specific intracellular compartments for proper intracellular processing.

AGS' MEVs

AGS believes that MEVs will play a key role in the fields of innovative drug delivery and gene therapy solutions.

AGS’ MEVs from Chlorella vulgaris can be loaded with a variety of biologically active payload molecules, such as siRNA, mRNA, plasmids, proteins, peptides, and small molecules.

AGS’ MEVs from Chlorella vulgaris have shown their ability to bypass stringent biological barriers, such as the gastro-intestinal and the brain penetration barriers.

Structure of the MEV and payload spectrum