Aethlon Medical, Inc. (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.
Dr. Barry Holtz, President of iBio CDMO said, “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.”
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 stated, “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.”
About Aethlon Medical, Inc.
Aethlon Medical is focused on addressing unmet needs in global health and biodefense. 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.
In collaboration with leading government and non-government research institutes, Aethlon has validated the ability of the Hemopurifier® to capture a broad-spectrum of pandemic influenza viruses, mosquito-borne viruses and deadly hemorrhagic viruses. Based on its use to treat Ebola virus, the Hemopurifier® was named a “Top 25 Invention” and one of the “Eleven Most Remarkable Advances in Healthcare,” by TIME Magazine.
Aethlon is also investigating the potential therapeutic use of the Hemopurifier® to reduce the presence of tumor-derived exosomes, which contribute to immune-suppression and the spread of metastasis in cancer patients. Additionally, Aethlon is the majority owner of Exosome Sciences, Inc. (ESI), which is focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disorders, including Alzheimer’s disease (AD) and Chronic Traumatic Encephalopathy (CTE). Additional information can be found online at www.AethlonMedical.com and www.ExosomeSciences.com. You can also connect with us on Twitter, LinkedIn, Facebook and Google+.
About iBio, Inc.
iBio, a leader in developing plant-based biopharmaceuticals, provides a range of product and process development, analytical, and manufacturing services at the large-scale development and manufacturing facility of its subsidiary iBio CDMO, LLC. in Bryan, Texas. The facility houses laboratory and pilot-scale operations, as well as large-scale automated hydroponic systems capable of growing over four million plants as “in process inventory” and delivering over 300 kilograms of therapeutic protein pharmaceutical active ingredient per year. iBio applies its technology for the benefit of its clients and the advancement of its own product interests. The Company’s pipeline is comprised of proprietary candidates for the treatment of a range of fibrotic diseases including idiopathic pulmonary fibrosis, systemic sclerosis, and scleroderma. IBIO-CFB03, based on the Company’s proprietary gene expression technology, is the Company’s lead therapeutic candidate being advanced for IND development.