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Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company focused on unmet needs in global health and biodefense, announced today that it has established a collaboration with iBio, Inc. (NYSE AMERICAN: IBIO) to support potential large-scale production of the Aethlon Hemopurifier®. iBio is a leading developer of plant-based biopharmaceuticals.
The Aethlon Hemopurifier® is a first-in-class therapeutic device designed to address life-threatening viral infections. The United States Food and Drug Administration (FDA) has designated the Hemopurifier® to an Expedited Access Pathway (EAP) related to the treatment of life-threatening viruses that are not addressed with approved therapies.
The goal of the Aethlon-iBio collaboration is to advance large-scale production of a recombinant form of Galanthus nivalis agglutinin (GNA), a plant-derived lectin that is immobilized within the Hemopurifier® to bind infectious enveloped viruses. Aethlon further disclosed that it completed a feasibility study with iBio researchers that has confirmed the ability to produce highly active recombinant GNA through the use of iBio’s plant based technology.
Aethlon’s clinical success backed by our cGMP compliant therapeutic protein production capacity and expanded classified manufacturing space for device manufacture are an ideal combination for delivery of a new therapeutic approach to pandemic disease and biothreats,” said Dr. Barry Holtz, President of iBio CDMO.
iBio’s CDMO facilities were initially designed and constructed under sponsorship of the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, and have the capacity to initiate a rapid production response to an infectious disease outbreak or a bioterror attack and to manufacture large quantities of recombinant proteins under Current Good Manufacturing Practices (cGMP’) of the U.S. Food and Drug Administration.
Jim Joyce, Chairman and CEO of Aethlon concluded, “The production of recombinant GNA in iBio’s large-scale manufacturing facilities establishes a pathway for us to access a consistent, high quality supply that can support our long-term clinical and commercialization objectives.”