In the rapidly evolving landscape of medicine, AGS Therapeutics has emerged as a trailblazer, harnessing the untapped potential of Microalgae Extracellular Vesicles (MEVs) to revolutionise drug delivery and transform healthcare.

Founded in 2020 with a mission to pioneer MEVs as a new delivery system for therapeutic modalities and vaccines, AGS Therapeutics has achieved remarkable success in this groundbreaking field. At the heart of its innovation lies Chlorella, a freshwater unicellular microalga, which nature has perfected as a producer of large quantities of extracellular vesicles – an elegant and efficient natural delivery system that has evolved over billions of years.

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Nature’s Expert Delivery System: The Prowess of Chlorella

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Chlorella stands as a testament to the wonders of nature. A simple organism thriving in freshwater, Chlorella requires minimal resources to grow – just light, fresh water, and essential minerals. Despite its simplicity, Chlorella holds a remarkable ability: the natural production of extracellular vesicles. These tiny, membrane-bound vesicles serve as nature’s masterful couriers, transferring molecules between cells and organisms.

AGS Therapeutics has recognised the incredible potential of Chlorella’s extracellular vesicles, MEVs, as a novel delivery system. With the wisdom of billions of years of evolution in transporting molecules, AGS Therapeutics harnesses this efficiency to unlock new possibilities for therapeutic modalities and vaccines, setting the stage for a revolutionary approach to drug delivery.

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Two Pathways to Loading: Exo-Loading and Endo-Loading

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The company’s innovation in drug delivery is not limited to harnessing MEVs’ natural capabilities. The company has developed two primary approaches to load MEVs effectively: exo-loading and endo-loading.

In exo-loading, scientists from AGS Therapeutics apply various physicochemical methods to unmodified MEVs, empowering them to load diverse types of molecules. These molecules can range from essential mRNA and siRNA to plasmids, proteins, peptides, and small molecules. This versatility makes exo-loading a powerful tool for delivering a wide array of therapeutic payloads.

The second approach, endo-loading, represents a breakthrough in genetic engineering of nanoparticles. AGS Therapeutics has ingeniously modified Chlorella’s genetic makeup, enabling it to produce specific molecules internally. These molecules are naturally encapsulated within its extracellular vesicles. The potential of endo-loading is vast, offering a targeted and precision-driven approach to gene therapies and personalised medicine.

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Defying Biological Barriers: MEVs’ Unique Biodistribution

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AGS Therapeutics MEVs have proven to be true champions in overcoming biological barriers during their administration route, thus setting them apart from existing lipid nanoparticles (LNPs) or extracellular vesicles derived from mammalian cells. The ability to navigate and surpass these barriers gives them a solid competitive edge.

A critical challenge for new therapeutic modalities, such as RNA-based therapies, is delivering them beyond the liver. AGS Therapeutics MEVs have demonstrated their ability to effectively reach various organs, overcoming hurdles and promising targeted delivery where it matters the most.

The versatility of MEVs extends to various routes of administration. AGS Therapeutics’ in vivo experiments have demonstrated the exceptional potential of MEVs in traversing different administration pathways and reaching their intended targets with precision. Orally administered mRNA-loaded MEVs have been shown to reach the epithelial cells of the intestine and express mRNA, a feat previously thought to be elusive for oral drug therapies and a first’ world in the oral delivery and expression of mRNA. Intranasal delivery allows MEVs to travel along the olfactory tract, reaching diverse regions within the brain without having to cross the blood-brain barrier. Intratracheal administration effectively targets lung epithelial cells, holding immense promise for respiratory treatments. Additionally, AGS Therapeutics’ eye drops loaded with mRNA-loaded MEVs have been proven to reach and express the mRNA payload in the retina/choroid tissue. This breakthrough holds significant potential for treating retinal diseases, eliminating the need for invasive intravitreal injections, and improving patient comfort.

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A Visionary Development Plan: Leading the Future of Medicine

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AGS Therapeutics envisions a two-fold development plan that positions the company as a frontrunner in the healthcare industry. The first pillar focuses on establishing an internal pipeline of therapeutics, with AGS’ researchers diligently working on the selection of the company’s first two groundbreaking products. AGS is committed to addressing critical medical needs and delivering transformative solutions through its internal research and development endeavours.

In addition to its internal pipeline, the company seeks strategic collaborations with pharma /biotech companies, forming the second pillar of its development plan. Partnering with established industry leaders brings together a wealth of expertise, resources, and networks. These collaborations expedite the development and commercialisation of AGS’ innovative therapies, ensuring they reach patients worldwide efficiently and effectively.

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Empowering the Future: Advanced Manufacturing for Global Impact

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AGS Therapeutics recognises that the successful translation of breakthrough innovations into real-world applications requires robust manufacturing capabilities. As a pioneer in MEV-based therapeutics, the organisation is committed to developing a cutting-edge manufacturing platform.

Currently, no other industry player is producing MEVs at a large scale. AGS’ Therapeutics dedication to manufacturing excellence sets the company apart as an industry leader. Its state-of-the-art manufacturing processes are scalable, consistent, and industrialisable. AGS Therapeutics currently works on setting a dedicated manufacturing unit to be compliant with Good Manufacturing Practices (GMP) norms. By meeting these stringent regulatory requirements, AGS Therapeutics aims to file its first Investigational New Drug (IND) application with the FDA by end-2025/ early-2026, paving the way for accelerated drug development and approvals.

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AGS Therapeutics stands at the forefront of medical advancements, harnessing the unparalleled potential of Chlorella and MEVs to create a new era in drug delivery systems. With a diverse range of applications and the ability to overcome biological barriers, MEVs offer a transformative platform for delivering new therapeutic modalities, vaccines, and non-viral gene therapies. AGS’ visionary development plan, coupled with its commitment to manufacturing excellence, is poised to make a significant impact on the medical landscape, promising groundbreaking solutions for better health and wellness.

Comprehensive insight into the science and technology behind the pioneering work of this exciting Paris based company, together with up to date news, press releases and contact points can be found on AGS Therapeutics website –  https://www.ags-tx.com/  

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