« AGS Therapeutics to collaborate with Sanofi on intestinal mucosal vaccination by oral administration using AGS’ MEV technology as a vaccinal delivery system », Evry, FR, Oct. 10, 2024.

MEVs are a universal delivery system; suitable for delivering innovative therapeutics, vaccines and gene therapies. MEVs can be loaded with a diversity of payloads or therapeutic modalities and administered through multiple routes; they overcome stringent biological barriers and reach difficult-to-access tissues, thus overcoming challenges faced by other delivery systems. MEVs deliver their payload in target tissues of interest, where the payload elicits its desired biological activity.

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AGS Therapeutics to collaborate with Sanofi on intestinal mucosal vaccination by oral administration using AGS’ MEV technology as a vaccinal delivery system

MEVs are a universal delivery system; suitable for delivering innovative therapeutics, vaccines and gene therapies. MEVs can be loaded with a diversity of payloads or therapeutic modalities and administered through multiple routes; they overcome stringent biological barriers and reach difficult-to-access tissues, thus overcoming challenges faced by other delivery systems. MEVs deliver their payload in target tissues of interest, where the payload elicits its desired biological activity.

Evry, France, October 10, 2024 – AGS Therapeutics, a preclinical-stage biotech company pioneering microalgae extracellular vesicles (MEVs) as a new, universal delivery system, today announced that it has entered into an agreement with Sanofi, in the context of the 2024 iDEA-TECH Awards. AGS will thus embark on a twelve-month collaborative research project together with scientific experts at Sanofi’s Vaccine business unit to further validate AGS’ MEVs against undisclosed targets, in general, and as a vaccinal delivery system for oral-intestinal mucosal vaccination, in particular. This collaborative work leverages the unique capabilities of AGS’ MEVs and the strength of AGS’ intellectual property in the vaccination and immunomodulation fields (cf. PR from October 1, 2024, on the publication of the relevant patent). 

“We look forward to working alongside Sanofi’s teams of vaccine experts to advance our MEVs and their use in intestinal mucosal vaccination by oral administration," said Marie-Hélène Leopold, Chief Corporate Development Officer, AGS Therapeutics. “Advances in mucosal vaccination are much needed as mucous membranes represent the first line of defence against viruses and bacteria.”

Thanks to their rare and natural capacity to overcome certain stringent biological barriers, MEVs can deliver payloads to tissues and organs that have been difficult or impossible to access by current alternative systems like LNPs, viral gene therapy vectors, or mammalian EVs. 

Upon oral administration, MEVs have demonstrated that they can pass the gastric barrier. Once in the intestine, they are internalized by the intestinal epithelial cells, where they deliver their biologically active payload. In the intestine, MEVs are also internalized by resident macrophages and dendritic cells from the GALT (Gut Associated Lymphoid Tissue). By oral administration, antigen-loaded MEVs elicit an immune response against antigenic payloads. The humoral response includes class switching from IgG to IgA, indicating the generation of antigen-specific mucosal immunity. No neutralizing response to MEVs is observed when administered orally, which allows for repeat dosing.

“We are very excited about this opportunity with Sanofi, a world leader in vaccines, which highlights the potential of AGS’ MEV technology for vaccination”, said Manuel Vega, AGS’ CEO. “This collaboration highlights the attractiveness of AGS’ MEV technology and significantly reduces the risk for our internal vaccines vertical, paving the way for discussions on licensing on the 2026 horizon”. 

Oral and mucosal vaccinations are long-awaited solutions for addressing largely unmet needs in the vaccine field, with the potential to significantly impact global public health challenges, including future pandemics (like past SARS-CoV), and specific epidemics (like Influenza, Cholera, Polio, HIV…). 

About Sanofi iDEA-TECH Awards

Sanofi Innovations in Data Exploration, Analytics, and TECHnology Awards (iDEA-TECH Awards) is an annual call for projects hosted by Sanofi. Through this initiative, Sanofi supports promising biotech companies or academics working on cutting-edge technologies and strengthens its position as a partner of choice. AGS Therapeutics was selected from a competitive pool of applicants based on the potential of its MEV-based delivery platform, its experienced leadership team, and the potential impact of its collaborative research project for vaccines. « The Sanofi iDEA TECH Awards are seed funding dedicated to supporting innovative ideas coming from Europe and North America for a one-year proof-of-concept study related to a technology that Sanofi would like to see if the idea could work. This could be a stepping stone to further collaboration if the concept becomes proven. The technology proposed by AGS Therapeutics will be tested in the coming 12 months, and we will have a first vision of it” declares Daniel Larocque, Innovation lead at Sanofi.

About AGS

AGS Therapeutics, based at Genopole (www.genopole.fr), Evry, France, is a biotech company pioneering the use of microalgae extracellular vesicles (MEVs) as a universal delivery system for innovative biologics, vaccines and gene therapies. AGS has shown MEVs to be a safe, targeted and highly versatile delivery system for mRNA, siRNA, DNA oligos, plasmids, proteins, and peptides relevant to a broad range of human diseases. AGS-M, the company’s CDMO subsidiary, produces the MEVs needed to support R&D from AGS and from companies partnering with AGS. AGS’ MEVs are derived from Chlorella, a two-billion-year-old single-cell algae, labelled by the FDA as GRAS for consumption as a food supplement. AGS’ MEVs are easy to manufacture in large quantities with processes that are both eco-friendly and easily scalable. Through strategic partnerships and a commitment to scientific excellence, the company aims to challenge the delivery landscape and improve the lives of patients across the globe. For more information visit www.ags-tx.com and www.ags-m.com.

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 judgement 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. 

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

All Press Releases
« AGS Therapeutics strengthens its Patent Portfolio on Microalgae Extracellular Vesicles (MEVs) with an International Patent Application for the use of MEVs in vaccines, including oral mucosal vaccination, and immunomodulation », Evry, FR, Oct. 1, 2024.
« AGS Therapeutics Announces the Appointment  of Dr. Renee T. Williams as an Independent Board Member », Paris, France, July 8, 2024.
« AGS Therapeutics Strengthens its Patent Portfolio on Microalgae Extracellular Vesicles (MEVs) with an International Application on the use of MEVs to deliver biological agents to the brain by the intranasal route of administration », Paris, May 7, 2024.
« AGS Therapeutics Strengthens its Patent Portfolio on Microalgae Extracellular Vesicles (MEV) with an International Patent Application on MEVs from Genetically Modified Microalgae Containing Endogenously-Loaded Payloads », Paris, FR, January 17, 2024.
« AGS Therapeutics Named among BWM’s 20 Most Innovative Companies to Watch in 2023 », London, UK, August 2023.
« AGS Therapeutics Strengthens its Patent Portfolio on Microalgae Extracelluar Vesicles (MEV) with an International Patent Application on Biodistribution and Uses of MEVs as Delivery System to Reach Difficult to Access Tissues », Paris, FR, August 7, 2023.
« AGS Therapeutics Announces Move to Spartners, the already Prestigious Accelerator within the Paris-Saclay Life Sciences Hub », Paris, FR, May 30, 2023.
« AGS Therapeutics Strenghtens its Patent Portfolio on Microalgae Extracelluar Vesicles (MEV) with an  International Patent Application on Preparation and Uses of MEVs as a Universal Drug Delivery System », Paris, FR, Mai 8, 2023.
« AGS Therapeutics Unveils Ambitious R&D Pipeline, Showcasing the Potential of its Universal Delivery System for Novel Therapeutics », Paris, FR, April 4, 2023.
« Novel drug delivery system to overcome barriers | AGS Therapeutics to Present at BIO CEO & Investor Conference NYC », Paris, FR, February 6, 2023.
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