Evry, France, September 9, 2025 – AGS Therapeutics, a preclinical-stage biotechnology company pioneering microalgae extracellular vesicles (MEVs) as a universal delivery system, today announced the publication of the PCT International Application N° PCT/EP2025/054721 - Publicationn WO2025/176843, titled Microalgae Extracellular Vesicle Based Gene Therapy Vectors (MEV-GTVs), Their Preparation, and Uses Thereof, protecting the use of MEVs for DNA-based gene therapies.

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The published patent underscores and demonstrates the use of MEVs to deliver plasmid DNA and other gene therapy payloads safely and non-invasively, using multiple routes of administration. This breakthrough opens new opportunities for cost-effective, redosable, and sustainable gene therapies—addressing major limitations of current viral-vector approaches such as adeno-associated viruses (AAVs).

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MEVs represent a universal delivery system suitable for innovative therapeutics, vaccines, and gene therapies. They can be loaded with a wide range of payloads and administered through multiple routes. By overcoming stringent biological barriers and reaching hard-to-access tissues, MEVs address challenges that have long restricted other delivery platforms. Once delivered to target tissues, MEVs release their payload, triggering the intended biological activity.

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“Our research demonstrates that MEVs can be loaded with plasmid DNA, which is then released into the target cell nucleus to drive sustained gene expression,” said Lila Drittanti, Chief Operating Officer of AGS Therapeutics. “This unprecedented capability of MEVs unlocks opportunities unimaginable on gene therapy with current viral vectors: non-viral, non-invasive treatments via multiple administration routes; long-lasting and repeat dosing; and, more cost-effective and sustainable manufacturing that supports equitable access worldwide.”

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Thanks to their unique ability to cross stringent biological barriers, MEVs can deliver therapeutic payloads to tissues and organs previously inaccessible with viral vectors, lipid nanoparticles (LNPs), or mammalian EVs.

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“This patent application marks a foundational step for MEV-mediated gene therapies, and implies a transformative impact on the gene therapy field”, said Marie-Hélène Leopold, Chief Corporate Development Officer of AGS Therapeutics. “It establishes a new vertical in our pipeline and strengthens AGS’s position in multi-billion-dollar markets with a highly competitive non-viral alternative.”

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"The potential of MEVs to overcome current limitations in gene therapy delivery is very exciting. The ability of MEVs to safely transport a wide variety of therapeutic payloads—including DNA and RNA—across biological barriers and to hard-to-reach tissues holds the promise to truly revolutionize the landscape of genomic medicine. AGS’s work with MEVs could unlock safer, redosable, and more accessible gene therapies for patients in need, potentially transforming treatment for numerous diseases that have long been out of reach for existing technologies" said Tamar Grossman, member of AGS’ Board of Directors.

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AGS’ portfolio of Intellectual Property is managed by Stephanie Seidman, at Womble Bond Dickinson, San Diego (www.womblebonddickinson.com/us/people/stephanie-seidman).

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About AGS

AGS Therapeutics (Evry, France) is pioneering the use of microalgae extracellular vesicles (MEVs) as a universal delivery system for innovative therapeutics, vaccines, and gene therapies. AGS has demonstrated that MEVs are a safe, targeted, and highly versatile delivery platform for mRNA, siRNA, DNA oligonucleotides, plasmids, proteins, and peptides relevant to a wide range of human diseases. AGS-M, the company’s CDMO subsidiary, manufactures MEVs to support AGS’s own research as well as collaborative programs with partner companies. The company’s MEVs are derived from Chlorella, a two-billion-year-old single-cell alga classified by the FDA as GRAS (Generally Recognized as Safe) for consumption as a food supplement. MEVs can be manufactured at scale through eco-friendly and cost-efficient processes. Through strategic collaborations and a commitment to scientific excellence, AGS aims to transform the drug delivery landscape and improve patient outcomes worldwide. For more information, visit www.ags-tx.com and www.ags-m.com.

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Forward looking statement

This announcement may include predictions, estimates or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this communication.

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Contacts 

Marie-Hélène Leopold | AGS Therapeutics | +33 (0)6 07 16 55 01 | mhl@ags-tx.com

Ana Vega | Markets & Listing | +33 (0)6 88 57 05 77 | av@markets-listing.com

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